{"id":"W4416873946","doi":"10.1109/issrew67781.2025.00063","title":"Linking Medical Device Assurance Cases","year":2025,"lang":"","type":"article","venue":"","topic":"Safety Systems Engineering in Autonomy","field":"Engineering","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"McMaster University; McMaster University Medical Centre","funders":"Natural Sciences and Engineering Research Council of Canada","keywords":"Traceability; Certification; Quality assurance; Medical device; Trustworthiness; Key (lock); Patient safety","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0318807,0.001383382,0.0008352312,0.008724274,0.002566408,0.01153022,0.004216981,0.006158771,0.01155653],"category_scores_gemma":[0.1026468,0.001505307,0.002426433,0.003185518,0.00441419,0.01302832,0.01222995,0.005340996,0.002684284],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005117051,"about_ca_system_score_gemma":0.009769159,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006517468,"about_ca_topic_score_gemma":0.003543214,"domain_scores_codex":[0.9523837,0.01574393,0.00543176,0.004604126,0.01954005,0.002296468],"domain_scores_gemma":[0.9117008,0.04522466,0.006553993,0.02157104,0.0133143,0.001635063],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.0002000783,0.0003924115,0.01394037,0.001000949,0.0001469888,0.004933593,0.007026459,0.02106064,0.004080389,0.7310084,0.01313048,0.2030792],"study_design_scores_gemma":[0.0001233718,0.0002512327,0.003561381,0.002341627,0.0002829533,0.004808107,0.002378695,0.06756281,0.01746907,0.5274997,0.3735084,0.0002126669],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":"theoretical_or_conceptual","genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.02700755,0.001358821,0.8885571,0.008060122,0.0004040594,0.001892538,0.001384362,0.003378879,0.06795663],"genre_scores_gemma":[0.3932514,0.002005154,0.5759902,0.002738505,0.0003894663,0.00131374,0.004117806,0.001239468,0.01895419],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.0318807,"threshold_uncertainty_score":0.1686033,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01112637948312151,"score_gpt":0.249098475247726,"score_spread":0.2379720957646045,"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."}}