{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.0007561269,0.0005405733,0.0006753238,0.0003429309,0.0001326599,0.0001313064,0.0007492973,0.0006366118,0.001381247],"category_scores_gemma":[0.0009647392,0.0006049575,0.0002031692,0.00104617,0.00007177892,0.0002091853,0.0002027147,0.0008216967,0.0005940358],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004334183,"about_ca_system_score_gemma":0.0005685926,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001627168,"about_ca_topic_score_gemma":0.0001309987,"domain_scores_codex":[0.996868,0.00007127003,0.001098527,0.0005417621,0.0006201686,0.000800327],"domain_scores_gemma":[0.9970703,0.001682087,0.00006093597,0.0007947051,0.0001105476,0.0002814336],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"simulation_or_modeling","study_design_gemma":"simulation_or_modeling","study_design_scores_codex":[0.00004659071,0.000288011,0.02454749,0.02110254,0.00300239,0.002284337,0.001097455,0.5404694,0.001478066,0.1275673,0.03270427,0.2454122],"study_design_scores_gemma":[0.0008225459,0.00002101779,0.005619287,0.006351402,0.0001033897,0.0002125157,0.0001076553,0.5224279,0.00199121,0.00007522627,0.4614272,0.0008407115],"study_design_candidate":"simulation_or_modeling","study_design_consensus":"simulation_or_modeling","genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.0111243,0.02493603,0.6060822,0.002478712,0.01681431,0.0007724497,0.00001514396,0.00258375,0.3351931],"genre_scores_gemma":[0.9877505,0.0004842188,0.004579636,0.0004630977,0.0005865954,0.00006004669,0.000005897452,0.00008788706,0.005982133],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.9766262,"threshold_uncertainty_score":0.9996402,"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."}}