{"id":"W4399998882","doi":"10.2196/56241","title":"Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study","year":2024,"lang":"en","type":"article","venue":"JMIR Formative Research","topic":"Delphi Technique in Research","field":"Social Sciences","cited_by":6,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Snowball sampling; Rigour; Health care; Relevance (law); Computer science; Delphi method; Nonprobability sampling; Agile software development; Qualitative research; Health technology; Medicine; Medical physics; Management science; Process management; Artificial intelligence; Engineering","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":true,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.17352,0.0009715179,0.001123503,0.004518908,0.009085153,0.007024087,0.003224166,0.005185355,0.005526892],"category_scores_gemma":[0.1838107,0.001749289,0.001181827,0.002781782,0.01091787,0.009248406,0.01725476,0.005777923,0.001291861],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.009490943,"about_ca_system_score_gemma":0.02246334,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003458991,"about_ca_topic_score_gemma":0.003371403,"domain_scores_codex":[0.7972182,0.1765662,0.006145458,0.003218108,0.006930679,0.009921388],"domain_scores_gemma":[0.7496637,0.2098311,0.006926203,0.00393375,0.02195961,0.007685561],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"qualitative","study_design_gemma":"qualitative","study_design_scores_codex":[0.0004132707,0.001007378,0.01151183,0.001853296,0.0000492314,0.0009189795,0.9414911,0.0007600067,0.0008629202,0.007112771,0.002148622,0.03187066],"study_design_scores_gemma":[0.0000964565,0.0009991191,0.005471402,0.002663722,0.00002483912,0.0002805906,0.9717355,0.001593782,0.000602246,0.00274727,0.01369815,0.00008690549],"study_design_candidate":"qualitative","study_design_consensus":"qualitative","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9564292,0.0007735812,0.01244086,0.007516575,0.0001978177,0.008945324,0.000144241,0.00003294444,0.01351942],"genre_scores_gemma":[0.9667089,0.001258725,0.01184638,0.004963782,0.00005137952,0.01336393,0.00009044862,0.00003220822,0.001684161],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.17352,"threshold_uncertainty_score":0.9176726,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3541652300681898,"score_gpt":0.6602425374210544,"score_spread":0.3060773073528646,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}