{"id":"W3022499025","doi":"10.2196/17567","title":"Medical Device Apps: An Introduction to Regulatory Affairs for Developers","year":2020,"lang":"en","type":"article","venue":"JMIR mhealth and uhealth","topic":"Health Systems, Economic Evaluations, Quality of Life","field":"Economics, Econometrics and Finance","cited_by":62,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Documentation; Directive; Medical software; Software; European union; Process (computing); Computer science; Conformity assessment; Business; Computer security; Software development","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":true,"about_ca":false,"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":[0.0202383,0.001415028,0.001004101,0.004937943,0.003067876,0.01165396,0.002092636,0.01110826,0.0123328],"category_scores_gemma":[0.03413953,0.00163802,0.001318701,0.004015617,0.003919819,0.01551114,0.005589864,0.01236613,0.01695515],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003837112,"about_ca_system_score_gemma":0.008791463,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003564488,"about_ca_topic_score_gemma":0.003050836,"domain_scores_codex":[0.9674526,0.008069959,0.004765714,0.002083699,0.01637715,0.001250823],"domain_scores_gemma":[0.9645854,0.01877203,0.002758093,0.002194649,0.01068959,0.001000326],"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":[0.00006892971,0.0002161277,0.0005301673,0.001453762,0.000009655708,0.0005611237,0.003948946,0.0004826505,0.002520631,0.207162,0.5165346,0.2665114],"study_design_scores_gemma":[0.000003955773,0.00003121008,0.0002093729,0.0008616194,0.000003144603,0.0002418877,0.0001986602,0.00008372668,0.000204716,0.005156237,0.9929847,0.00002084003],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.006885518,0.2283497,0.1173246,0.2125829,0.02862313,0.00204526,0.003659228,0.004990108,0.3955396],"genre_scores_gemma":[0.04488671,0.293874,0.2005455,0.1266506,0.03415716,0.003781103,0.007490012,0.003754601,0.2848604],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.0202383,"threshold_uncertainty_score":0.1070316,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3556533912650015,"score_gpt":0.4709701952938343,"score_spread":0.1153168040288329,"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."}}