{"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":"codex-gemma-dda1882f352a","candidate_categories":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.0002380436,0.00005738362,0.00009125469,0.000009996831,0.0002697741,0.0001053232,0.0002139841,0.00003778466,0.0009768854],"category_scores_gemma":[0.0001505537,0.00002727077,0.000006204667,0.0002151838,0.0000786938,0.0001075835,0.0001661271,0.0000891162,0.000008345989],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00001324669,"about_ca_system_score_gemma":0.000004121121,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01189232,"about_ca_topic_score_gemma":0.01312753,"domain_scores_codex":[0.9992442,0.00004762673,0.0001226991,0.000174699,0.0002928668,0.0001179354],"domain_scores_gemma":[0.9997188,0.00001521737,0.0000573012,0.00002805855,0.0001233053,0.00005733173],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.0004695586,0.0005404184,0.1497065,0.002589282,0.0001369892,0.00005218994,0.01404978,0.00002809747,0.02546927,0.00813355,0.03903705,0.7597873],"study_design_scores_gemma":[0.000382118,0.0003546429,0.6202807,0.0001028748,0.000005583871,0.0000484714,0.006800575,0.0001620737,0.0003724086,0.0001460397,0.3711491,0.0001954323],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9904739,0.00007582753,4.484119e-7,0.001264364,0.00001304792,0.0001541894,0.00003016392,0.00002688753,0.007961146],"genre_scores_gemma":[0.9996311,0.00006321237,0.000004055079,0.00007231006,0.00002871526,2.73738e-8,0.00012889,0.00001084688,0.00006083822],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.7595919,"threshold_uncertainty_score":0.9999363,"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."}}