{"id":"W6968554262","doi":"10.5281/zenodo.3531735","title":"APPROVAL PROCESS AND REGISTRATION PROCESS OF MEDICAL DEVICES IN US, CANADA AND INDIA","year":2019,"lang":"en","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Fisheries and Aquaculture Studies","field":"Agricultural and Biological Sciences","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Medical device; Process (computing); Key (lock); Government regulation; Medical equipment; Health technology; Government (linguistics)","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":[0.02178385,0.000573319,0.0005823203,0.004393853,0.005937646,0.009706446,0.002626198,0.004341159,0.02752589],"category_scores_gemma":[0.0513092,0.0007052647,0.001196988,0.004779094,0.003645606,0.002507328,0.002982357,0.003870621,0.01672366],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.03346405,"about_ca_system_score_gemma":0.09228256,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.4558077,"about_ca_topic_score_gemma":0.4242797,"domain_scores_codex":[0.9564296,0.005134438,0.004304639,0.002745848,0.02629742,0.005088062],"domain_scores_gemma":[0.930507,0.01143051,0.003144121,0.003612455,0.04839871,0.002907156],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0003550773,0.0001512399,0.008588405,0.001145795,0.00005779018,0.001144944,0.005457228,0.0006087853,0.005275846,0.1602897,0.591826,0.2250992],"study_design_scores_gemma":[0.0000311404,0.00006761281,0.01216406,0.0003162076,0.0000317858,0.0004018042,0.0009178506,0.0002843523,0.002698971,0.001634582,0.9813638,0.00008786993],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.02109632,0.008165673,0.01537568,0.06058161,0.003959647,0.005959186,0.00725739,0.001858619,0.8757458],"genre_scores_gemma":[0.2366632,0.01219192,0.03325231,0.04050614,0.001507004,0.003040818,0.0101504,0.0009737097,0.6617146],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.5441923,"threshold_uncertainty_score":0.9063092,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01265770271965959,"score_gpt":0.2131708847372095,"score_spread":0.2005131820175499,"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."}}