{"id":"W2778113859","doi":"10.1177/2168479017716712","title":"A Comparative Study of Medical Device Regulations: US, Europe, Canada, and Taiwan","year":2017,"lang":"en","type":"review","venue":"Therapeutic Innovation & Regulatory Science","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":38,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"Food and Drug Administration","keywords":"Medical device; Harmonization; Business; Risk analysis (engineering); Variety (cybernetics); Product (mathematics); Pharmacy; Health technology; Medicine; Computer science; Health care; Political science","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"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":[0.004023105,0.0004076971,0.001721428,0.006413394,0.0007024338,0.002163598,0.0008457014,0.001003122,0.00215374],"category_scores_gemma":[0.007855053,0.0002255722,0.001387917,0.01526312,0.0008074543,0.001027302,0.001049316,0.0007985222,0.00007935522],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007013628,"about_ca_system_score_gemma":0.02453301,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.1859597,"about_ca_topic_score_gemma":0.5011417,"domain_scores_codex":[0.9982995,0.0003463152,0.0003290075,0.0001638022,0.0006845202,0.0001768319],"domain_scores_gemma":[0.9944375,0.003367295,0.001027053,0.00007786855,0.000952623,0.0001376517],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0006748919,0.0001661056,0.02950392,0.2534636,0.004226342,0.0008380132,0.004403712,0.0003867194,0.0007536583,0.01181069,0.01471585,0.6790566],"study_design_scores_gemma":[0.0001994462,0.0003568329,0.2313469,0.2722729,0.02230646,0.002079662,0.01452795,0.0002628753,0.001033963,0.001697597,0.4537663,0.0001491209],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.005983551,0.992379,0.0000366743,0.0003215648,0.0000365689,0.00002318169,0.0001471502,0.000001001376,0.001071285],"genre_scores_gemma":[0.03790979,0.9609974,0.0001439395,0.0005309859,0.00003137595,0.00002237788,0.0001473797,0.000001613215,0.0002151786],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9929864,"threshold_uncertainty_score":0.3697546,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.219277287652675,"score_gpt":0.4487336366723921,"score_spread":0.2294563490197171,"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."}}