{"id":"W2056065774","doi":"10.1615/jlongtermeffmedimplants.v17.i2.90","title":"What Is Involved in a Regulatory Trial Investigating a New Medical Device?","year":2007,"lang":"en","type":"article","venue":"Journal of Long-Term Effects of Medical Implants","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"Hamilton General Hospital; University of Toronto; McMaster University","funders":"","keywords":"Medical device; Clinical trial; Process (computing); Risk analysis (engineering); Medicine; Business; Medical emergency; Computer science","routes":{"ca_aff":true,"ca_fund":false,"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":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.3347554,0.001049201,0.00469408,0.003025763,0.008520785,0.01589952,0.004380727,0.05619647,0.007656022],"category_scores_gemma":[0.4606698,0.00140023,0.004329399,0.002191412,0.01994776,0.02324539,0.004254638,0.02685484,0.003178553],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007377403,"about_ca_system_score_gemma":0.02939513,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002969705,"about_ca_topic_score_gemma":0.0024903,"domain_scores_codex":[0.6368416,0.260251,0.02802739,0.01014956,0.05554021,0.009190191],"domain_scores_gemma":[0.4891393,0.3940803,0.04734923,0.01795202,0.0309668,0.02051229],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.002973258,0.002156231,0.03943465,0.008016986,0.002226035,0.01643354,0.02765852,0.002118524,0.005491434,0.3108552,0.1206076,0.462028],"study_design_scores_gemma":[0.001233767,0.002206168,0.01110974,0.01265367,0.001578994,0.02487388,0.01310682,0.004119054,0.004212197,0.3699201,0.5540115,0.0009741751],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.0197489,0.03822574,0.05005084,0.8159686,0.008054202,0.003159962,0.0001503649,0.0002304902,0.06441089],"genre_scores_gemma":[0.2772159,0.0275486,0.08428425,0.5545601,0.03405892,0.005849455,0.0001640103,0.0003824847,0.01593632],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.6652446,"threshold_uncertainty_score":0.820365,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03865849632023175,"score_gpt":0.3750157777278569,"score_spread":0.3363572814076252,"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."}}