{"id":"W2107293557","doi":"10.1373/clinchem.2011.165860","title":"The Challenges and Concerns Companies Face Pertaining to the US Food and Drug Administration 510(k) Process for Cardiac Biomarkers","year":2011,"lang":"en","type":"article","venue":"Clinical Chemistry","topic":"Acute Myocardial Infarction Research","field":"Medicine","cited_by":5,"is_retracted":false,"has_abstract":true,"ca_institutions":"Response Biomedical (Canada)","funders":"Roche Diagnostics; Abbott Diagnostics; Siemens; Ortho Clinical Diagnostics; Bio-Rad Laboratories","keywords":"Medicine; Food and drug administration; Acute coronary syndrome; Clearance; Myocardial infarction; Troponin I; Population; Troponin; Medical laboratory; Troponin complex; Appropriate Use Criteria; Roche Diagnostics; Internal medicine; Intensive care medicine; Cardiology; Medical emergency; Pathology; Environmental health","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0009928194,0.000117348,0.000251668,0.000007295773,0.0002273016,0.00003421611,0.0001289492,0.0001083589,0.000006036897],"category_scores_gemma":[0.00119457,0.00006977522,0.00009121385,0.00004654017,0.0004535924,0.00003221251,0.0000802342,0.0002470793,0.000002187508],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00001501569,"about_ca_system_score_gemma":0.0001166519,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000005135602,"about_ca_topic_score_gemma":0.000005599222,"domain_scores_codex":[0.998944,0.00005684729,0.0002957493,0.0003088833,0.0001795758,0.0002149181],"domain_scores_gemma":[0.9982837,0.0009780334,0.00007280536,0.0002796505,0.0001653337,0.0002204314],"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":[0.02569102,0.001377069,0.2419122,0.005773106,0.01221877,0.0000587788,0.05683269,0.000007749545,0.006573091,0.003134151,0.1307508,0.5156705],"study_design_scores_gemma":[0.007413224,0.004919948,0.1478036,0.0005268658,0.001109675,0.0001637506,0.1258313,0.001473195,0.09000004,0.001253552,0.6182736,0.001231283],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9617515,0.004117571,0.00001702727,0.02884242,0.0001179094,0.0006926179,0.00003159575,0.00003625234,0.004393156],"genre_scores_gemma":[0.9968837,0.001578561,0.00007412916,0.0005828873,0.0003990832,0.000140494,0.000008725946,0.00001521816,0.0003172061],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5144392,"threshold_uncertainty_score":0.2845351,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1761324870938888,"score_gpt":0.4224519470907159,"score_spread":0.2463194599968271,"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."}}