{"id":"https://openalex.org/W4416291539","doi":"https://doi.org/10.1038/s41746-025-02052-9","title":"Evaluating transparency in AI/ML model characteristics for FDA-reviewed medical devices","display_name":"Evaluating transparency in AI/ML model characteristics for FDA-reviewed medical devices","publication_year":2025,"publication_date":"2025-11-17","ids":{"openalex":"https://openalex.org/W4416291539","doi":"https://doi.org/10.1038/s41746-025-02052-9","pmid":"https://pubmed.ncbi.nlm.nih.gov/41249460"},"language":"en","primary_location":{"id":"doi:10.1038/s41746-025-02052-9","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-02052-9","pdf_url":"https://www.nature.com/articles/s41746-025-02052-9.pdf","source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://www.nature.com/articles/s41746-025-02052-9.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5083424801","display_name":"Viraj Mehta","orcid":"https://orcid.org/0000-0001-9351-2299"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Viraj Mehta","raw_affiliation_strings":["Stanford University, Department of Computer Science, Stanford, USA, CA","Stanford University, School of Medicine, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, Department of Computer Science, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"Stanford University, School of Medicine, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5035804467","display_name":"Abhinav Komanduri","orcid":null},"institutions":[{"id":"https://openalex.org/I1174212","display_name":"University of Southern California","ror":"https://ror.org/03taz7m60","country_code":"US","type":"education","lineage":["https://openalex.org/I1174212"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Abhinav Komanduri","raw_affiliation_strings":["University of Southern California, Department of Population and Public Health Sciences, Los Angeles, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Southern California, Department of Population and Public Health Sciences, Los Angeles, USA, CA","institution_ids":["https://openalex.org/I1174212"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5116748517","display_name":"Rishabh Singh Bhadouriya","orcid":null},"institutions":[{"id":"https://openalex.org/I170201317","display_name":"University of Pittsburgh","ror":"https://ror.org/01an3r305","country_code":"US","type":"education","lineage":["https://openalex.org/I170201317"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Rishabh Singh Bhadouriya","raw_affiliation_strings":["University of Pittsburgh, College of General Studies, Pittsburgh, USA, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pittsburgh, College of General Studies, Pittsburgh, USA, PA","institution_ids":["https://openalex.org/I170201317"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5007217873","display_name":"Vilina Mehta","orcid":"https://orcid.org/0000-0002-5211-7505"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Vilina Mehta","raw_affiliation_strings":["Stanford University, Department of Computer Science, Stanford, USA, CA","Stanford University, School of Medicine, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, Department of Computer Science, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"Stanford University, School of Medicine, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021820756","display_name":"Michael D. Johnson","orcid":"https://orcid.org/0000-0002-5813-9270"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Michael David Johnson","raw_affiliation_strings":["Stanford University, School of Medicine, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, School of Medicine, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101413271","display_name":"Priyanka Shrestha","orcid":"https://orcid.org/0000-0002-8438-2610"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Priyanka Shrestha","raw_affiliation_strings":["Stanford University, Department of Computer Science, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, Department of Computer Science, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5112362939","display_name":"Margaret C. Nikolov","orcid":null},"institutions":[{"id":"https://openalex.org/I4210137306","display_name":"Stanford Medicine","ror":"https://ror.org/03mtd9a03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210137306","https://openalex.org/I97018004"]},{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Margaret Nikolov","raw_affiliation_strings":["Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004","https://openalex.org/I4210137306"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5000807107","display_name":"Bhav Jain","orcid":"https://orcid.org/0000-0003-2648-4894"},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Bhav Jain","raw_affiliation_strings":["Stanford University, School of Medicine, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Stanford University, School of Medicine, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5041175834","display_name":"Nigam H. Shah","orcid":"https://orcid.org/0000-0001-9385-7158"},"institutions":[{"id":"https://openalex.org/I4210105015","display_name":"Stanford Health Care","ror":"https://ror.org/019wqcg20","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210105015"]},{"id":"https://openalex.org/I4210137306","display_name":"Stanford Medicine","ror":"https://ror.org/03mtd9a03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210137306","https://openalex.org/I97018004"]},{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Nigam Shah","raw_affiliation_strings":["Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA","Technology and Digital Solutions, Stanford Healthcare, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004","https://openalex.org/I4210137306"]},{"raw_affiliation_string":"Technology and Digital Solutions, Stanford Healthcare, Stanford, USA, CA","institution_ids":["https://openalex.org/I4210105015"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5082094092","display_name":"Kevin A. Schulman","orcid":"https://orcid.org/0000-0002-8926-5085"},"institutions":[{"id":"https://openalex.org/I121847817","display_name":"The Graduate Center, CUNY","ror":"https://ror.org/00awd9g61","country_code":"US","type":"education","lineage":["https://openalex.org/I121847817"]},{"id":"https://openalex.org/I4210137306","display_name":"Stanford Medicine","ror":"https://ror.org/03mtd9a03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210137306","https://openalex.org/I97018004"]},{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kevin Schulman","raw_affiliation_strings":["Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA. Kevin.Schulman@Stanford.Edu","Operations, Information and Technology (by courtesy), The Graduate School of Business, Stanford University, Stanford, USA, CA. Kevin.Schulman@Stanford.Edu","Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA. Kevin.Schulman@Stanford.Edu","institution_ids":["https://openalex.org/I97018004","https://openalex.org/I4210137306"]},{"raw_affiliation_string":"Operations, Information and Technology (by courtesy), The Graduate School of Business, Stanford University, Stanford, USA, CA. Kevin.Schulman@Stanford.Edu","institution_ids":["https://openalex.org/I121847817","https://openalex.org/I97018004"]},{"raw_affiliation_string":"Clinical Excellence Research Center, School of Medicine, Stanford University, Stanford, USA, CA","institution_ids":["https://openalex.org/I97018004","https://openalex.org/I4210137306"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":10,"corresponding_author_ids":["https://openalex.org/A5083424801"],"corresponding_institution_ids":["https://openalex.org/I97018004"],"apc_list":{"value":3060,"currency":"USD","value_usd":3060},"apc_paid":{"value":3060,"currency":"USD","value_usd":3060},"fwci":5.7874,"has_fulltext":true,"cited_by_count":11,"citation_normalized_percentile":{"value":0.96146512,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":99,"max":100},"biblio":{"volume":"8","issue":"1","first_page":"673","last_page":"673"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.7985000014305115,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.7985000014305115,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10883","display_name":"Ethics and Social Impacts of AI","score":0.025599999353289604,"subfield":{"id":"https://openalex.org/subfields/3311","display_name":"Safety Research"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.014700000174343586,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/transparency","display_name":"Transparency (behavior)","score":0.9315999746322632},{"id":"https://openalex.org/keywords/clearance","display_name":"Clearance","score":0.7287999987602234},{"id":"https://openalex.org/keywords/food-and-drug-administration","display_name":"Food and drug administration","score":0.6003000140190125},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.3269999921321869},{"id":"https://openalex.org/keywords/clinical-practice","display_name":"Clinical Practice","score":0.31850001215934753}],"concepts":[{"id":"https://openalex.org/C2780233690","wikidata":"https://www.wikidata.org/wiki/Q535347","display_name":"Transparency (behavior)","level":2,"score":0.9315999746322632},{"id":"https://openalex.org/C138944611","wikidata":"https://www.wikidata.org/wiki/Q1163287","display_name":"Clearance","level":2,"score":0.7287999987602234},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.6003000140190125},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4097000062465668},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.38029998540878296},{"id":"https://openalex.org/C121955636","wikidata":"https://www.wikidata.org/wiki/Q4116214","display_name":"Accounting","level":1,"score":0.37220001220703125},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.36149999499320984},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3580000102519989},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.3269999921321869},{"id":"https://openalex.org/C2779974597","wikidata":"https://www.wikidata.org/wiki/Q28448986","display_name":"Clinical Practice","level":2,"score":0.31850001215934753},{"id":"https://openalex.org/C2993312423","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medical practice","level":2,"score":0.3091999888420105},{"id":"https://openalex.org/C162118730","wikidata":"https://www.wikidata.org/wiki/Q1128453","display_name":"Actuarial science","level":1,"score":0.2782999873161316},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.2581999897956848},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.25600001215934753},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.2558000087738037},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.2547000050544739},{"id":"https://openalex.org/C2776007630","wikidata":"https://www.wikidata.org/wiki/Q2798912","display_name":"Accountability","level":2,"score":0.250900000333786}],"mesh":[],"locations_count":4,"locations":[{"id":"doi:10.1038/s41746-025-02052-9","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-02052-9","pdf_url":"https://www.nature.com/articles/s41746-025-02052-9.pdf","source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},{"id":"pmid:41249460","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/41249460","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"NPJ digital medicine","raw_type":null},{"id":"pmh:oai:doaj.org/article:d55f2e96a5664f01b81e72ae9e83ec19","is_oa":true,"landing_page_url":"https://doaj.org/article/d55f2e96a5664f01b81e72ae9e83ec19","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"npj Digital Medicine, Vol 8, Iss 1, Pp 1-8 (2025)","raw_type":"article"},{"id":"pmh:oai:europepmc.org:11432328","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/12624113","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Text"}],"best_oa_location":{"id":"doi:10.1038/s41746-025-02052-9","is_oa":true,"landing_page_url":"https://doi.org/10.1038/s41746-025-02052-9","pdf_url":"https://www.nature.com/articles/s41746-025-02052-9.pdf","source":{"id":"https://openalex.org/S4210195431","display_name":"npj Digital Medicine","issn_l":"2398-6352","issn":["2398-6352"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310319908","host_organization_name":"Nature Portfolio","host_organization_lineage":["https://openalex.org/P4310319908","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Nature Portfolio","Springer Nature"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"npj Digital Medicine","raw_type":"journal-article"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4416291539.pdf","grobid_xml":"https://content.openalex.org/works/W4416291539.grobid-xml"},"referenced_works_count":34,"referenced_works":["https://openalex.org/W166169566","https://openalex.org/W2811374795","https://openalex.org/W3016012157","https://openalex.org/W3119527628","https://openalex.org/W3143784018","https://openalex.org/W3160891011","https://openalex.org/W3177617320","https://openalex.org/W3206840963","https://openalex.org/W4200226212","https://openalex.org/W4205897661","https://openalex.org/W4220765976","https://openalex.org/W4229036772","https://openalex.org/W4284974349","https://openalex.org/W4321504267","https://openalex.org/W4321782827","https://openalex.org/W4361003621","https://openalex.org/W4380538374","https://openalex.org/W4382394524","https://openalex.org/W4387763575","https://openalex.org/W4387966489","https://openalex.org/W4391221083","https://openalex.org/W4391238866","https://openalex.org/W4391969619","https://openalex.org/W4392240076","https://openalex.org/W4392283037","https://openalex.org/W4396780322","https://openalex.org/W4400126525","https://openalex.org/W4401283978","https://openalex.org/W4401635636","https://openalex.org/W4403107901","https://openalex.org/W4403420201","https://openalex.org/W4403775133","https://openalex.org/W4407064919","https://openalex.org/W4407918369"],"related_works":[],"abstract_inverted_index":{"The":[0,89],"rapid":[1],"integration":[2],"of":[3,50,96,113],"artificial":[4],"intelligence":[5],"(AI)":[6],"and":[7,28,52,66,73,121,135],"machine":[8],"learning":[9],"(ML)":[10],"into":[11],"medical":[12,147],"devices":[13,43,57,114],"has":[14],"underscored":[15],"the":[16,25,62,108,137],"need":[17,138],"for":[18,55,139],"transparency":[19,133],"in":[20,41,70,145],"regulatory":[21],"reporting.":[22],"In":[23],"2021,":[24],"U.S.":[26],"Food":[27],"Drug":[29],"Administration":[30],"(FDA)":[31],"issued":[32],"Good":[33],"Machine":[34],"Learning":[35],"Practice":[36],"(GMLP)":[37],"principles,":[38],"but":[39],"adherence":[40],"FDA-reviewed":[42],"remains":[44],"uncertain.":[45],"We":[46],"reviewed":[47],"1,012":[48],"summaries":[49],"safety":[51],"effectiveness":[53],"(SSEDs)":[54],"AI/ML-enabled":[56],"approved":[58],"or":[59],"cleared":[60],"by":[61,101],"FDA":[63],"between":[64],"1970":[65],"December":[67],"2024.":[68],"Transparency":[69,82],"model":[71],"development":[72],"performance":[74,128],"was":[75,93],"assessed":[76],"using":[77],"a":[78,118],"novel":[79],"AI":[80],"Characteristics":[81],"Reporting":[83],"(ACTR)":[84],"score":[85,92],"across":[86],"17":[87],"categories.":[88],"average":[90],"ACTR":[91],"3.3":[94],"out":[95],"17,":[97],"with":[98],"modest":[99],"improvement":[100],"0.88":[102],"points":[103],"(95%":[104],"CI,":[105],"0.54-1.23)":[106],"after":[107],"2021":[109],"guidelines.":[110],"Nearly":[111],"half":[112,123],"did":[115,124],"not":[116,125],"report":[117,126],"clinical":[119],"study":[120],"over":[122],"any":[127],"metric.":[129],"These":[130],"findings":[131],"highlight":[132],"gaps":[134],"emphasize":[136],"enforceable":[140],"standards":[141],"to":[142],"ensure":[143],"trust":[144],"AI/ML":[146],"technologies.":[148]},"counts_by_year":[{"year":2026,"cited_by_count":11}],"updated_date":"2026-05-06T08:25:59.206177","created_date":"2025-11-17T00:00:00"}