{"id":"W2994754993","doi":"10.1097/ogx.0000000000000733","title":"The Morcellation “Debate” and the FDA 510(k) Process—A Call for Further Reform","year":2019,"lang":"en","type":"review","venue":"Obstetrical & Gynecological Survey","topic":"Gynecological conditions and treatments","field":"Medicine","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Saskatchewan","funders":"","keywords":"Medicine; Food and drug administration; Harm; Medical emergency; Law","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":[],"consensus_categories":[],"category_scores_codex":[0.111777,0.001040536,0.00329033,0.002661623,0.006569136,0.01728762,0.005443827,0.04781594,0.008554718],"category_scores_gemma":[0.1576598,0.0009179859,0.004398189,0.002624108,0.03234529,0.0331154,0.00756979,0.04888455,0.003387724],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01531281,"about_ca_system_score_gemma":0.05563984,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01265628,"about_ca_topic_score_gemma":0.01045755,"domain_scores_codex":[0.9367381,0.02962703,0.005013132,0.005536709,0.01854776,0.00453717],"domain_scores_gemma":[0.8071832,0.1457615,0.008618303,0.007550045,0.0234232,0.007463807],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0001732091,0.0001760241,0.0006370871,0.001469181,0.00006451058,0.0004613585,0.002377951,0.0004168337,0.0004284582,0.5125337,0.3544464,0.1268153],"study_design_scores_gemma":[0.0001548362,0.0001820816,0.001138678,0.005390361,0.00005992258,0.0004072315,0.001859453,0.0003511848,0.0002077152,0.1557937,0.8343392,0.0001157331],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"review","genre_scores_codex":[0.0006911007,0.03777495,0.00147361,0.9482182,0.006995934,0.00002898514,0.00003340104,0.00006457011,0.004719248],"genre_scores_gemma":[0.02354044,0.03754114,0.007018339,0.9141506,0.01444437,0.0001557536,0.00007008941,0.00007454762,0.003004666],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.111777,"threshold_uncertainty_score":0.5911402,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.110888212400254,"score_gpt":0.3796656222945211,"score_spread":0.2687774098942671,"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."}}