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It was retrospective and blinded, at three qualified medical institutions, with manual reading as the gold standard. The report says that the sensitivity and specificity of software-assisted reading reached the preset targets. It gives no figures. CMDE judged that the product “可以大幅缩短阅片时间，减轻临床医师工作量” (can greatly shorten reading time and lighten doctors' workload) while its triage accuracy meets clinical needs. On 27 October 2020, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE notes that false negatives could delay diagnosis and treatment. It asked the maker to keep studying how the algorithm generalizes and to review clinical use every year. 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Section 五、临床受益-风险评估 (clinical benefit-risk assessment).","title":"医疗器械产品注册技术审评报告：冠脉CT造影图像血管狭窄辅助分诊软件（CQZ2000143）","url":"https://www.cmde.org.cn/directory/web/cmde/images/udrC9kNU1OzTsM28zHRqrncz8HVrbio1vq31tXvyO28qOoQ1FaMjAwMDE0M6Opcy5wZGY=.pdf","date":"2020-10-27","written_by":"independent","quote":"该产品在保证分诊提示准确率满足临床需求的基础上，可以大幅缩短阅片时间，减轻临床医师工作量。"}],"replication":{"produced_by":["The software segmented and reconstructed the coronary arteries and myocardium on CTA images with deep learning.","It gave triage prompts for coronary stenosis, and doctors could correct the segmentation and the vessel names.","Manual reading served as the gold standard."],"must_hold":["Images come from CT scanners with 64 or more rows and meet CTA examination standards.","Patients do not have acute chest pain, diffuse coronary calcification or a history of percutaneous coronary intervention or bypass surgery.","Trained doctors use the prompts and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*CoronaryDoc* met its stenosis triage targets in China's review","metric":null,"comparator":{"against":"Manual reading as the gold standard, with preset targets for sensitivity and specificity","before":"Preset targets (values not given)","after":"Sensitivity and specificity reached the targets (no figures given)","basis":"measured","quote":"软件辅助阅片相对于金标准阅片敏感度、特异度达到预期目标","url":"https://www.cmde.org.cn/directory/web/cmde/images/udrC9kNU1OzTsM28zHRqrncz8HVrbio1vq31tXvyO28qOoQ1FaMjAwMDE0M6Opcy5wZGY=.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The trial measured accuracy on stored images and guided no care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/udrC9kNU1OzTsM28zHRqrncz8HVrbio1vq31tXvyO28qOoQ1FaMjAwMDE0M6Opcy5wZGY=.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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Section 五、临床受益-风险评估 (clinical benefit-risk assessment).","title":"医疗器械产品注册技术审评报告：冠脉CT造影图像血管狭窄辅助分诊软件（CQZ2000143）","url":"https://www.cmde.org.cn/directory/web/cmde/images/udrC9kNU1OzTsM28zHRqrncz8HVrbio1vq31tXvyO28qOoQ1FaMjAwMDE0M6Opcy5wZGY=.pdf","date":"2020-10-27","written_by":"independent","quote":"该产品在保证分诊提示准确率满足临床需求的基础上，可以大幅缩短阅片时间，减轻临床医师工作量。"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1079-source-0001"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：冠脉CT造影图像血管狭窄辅助分诊软件 (technical review report for the registration of coronary CT angiography stenosis triage-aid software), acceptance no. CQZ2000143, applicant 语坤（北京）网络科技有限公司. 27 October 2020. Section 五、临床受益-风险评估 (clinical benefit-risk assessment).","title":"医疗器械产品注册技术审评报告：冠脉CT造影图像血管狭窄辅助分诊软件（CQZ2000143）","url":"https://www.cmde.org.cn/directory/web/cmde/images/udrC9kNU1OzTsM28zHRqrncz8HVrbio1vq31tXvyO28qOoQ1FaMjAwMDE0M6Opcy5wZGY=.pdf","date":"2020-10-27","written_by":"independent","quote":"该产品在保证分诊提示准确率满足临床需求的基础上，可以大幅缩短阅片时间，减轻临床医师工作量。"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"In the maker's trial at three institutions that China's CMDE reviewed, CoronaryDoc's coronary stenosis triage met its sensitivity and specificity targets. No figures are given.","account":"Yukun (Beijing) Network Technology built CoronaryDoc, software that uses deep learning to segment and reconstruct the coronary arteries and heart muscle on coronary CT angiography. It flags suspected coronary stenosis for triage. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as an innovative device. The trial was the maker's. It was retrospective and blinded, at three qualified medical institutions, with manual reading as the gold standard. The report says that the sensitivity and specificity of software-assisted reading reached the preset targets. It gives no figures. CMDE judged that the product “可以大幅缩短阅片时间，减轻临床医师工作量” (can greatly shorten reading time and lighten doctors' workload) while its triage accuracy meets clinical needs. On 27 October 2020, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE notes that false negatives could delay diagnosis and treatment. It asked the maker to keep studying how the algorithm generalizes and to review clinical use every year. The product is not for patients with acute chest pain, such as acute coronary syndrome."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"value_present","value":{"kind":"record_fields","fields":{"model_version":"Release 2.0 (full version 2.0.0.005)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["model_version"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"CoronaryDoc (冠脉CT造影图像血管狭窄辅助分诊软件)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"China's CMDE finds that CoronaryDoc met its stenosis triage targets in the maker's trial and judges that it can greatly shorten reading time","headline":"*CoronaryDoc* met its stenosis triage targets in China's review"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["426ecfa968cf9aaf13b21caa225752958489255c57a038b0b16cc75d5d9d91d8"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Yukun (Beijing) Network Technology built CoronaryDoc, software that uses deep learning to segment and reconstruct the coronary arteries and heart muscle on coronary CT angiography. It flags suspected coronary stenosis for triage. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as an innovative device. The trial was the maker's. It was retrospective and blinded, at three qualified medical institutions, with manual reading as the gold standard. The report says that the sensitivity and specificity of software-assisted reading reached the preset targets. It gives no figures. CMDE judged that the product “可以大幅缩短阅片时间，减轻临床医师工作量” (can greatly shorten reading time and lighten doctors' workload) while its triage accuracy meets clinical needs. On 27 October 2020, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE notes that false negatives could delay diagnosis and treatment. It asked the maker to keep studying how the algorithm generalizes and to review clinical use every year. The product is not for patients with acute chest pain, such as acute coronary syndrome.","replication":{"produced_by":["The software segmented and reconstructed the coronary arteries and myocardium on CTA images with deep learning.","It gave triage prompts for coronary stenosis, and doctors could correct the segmentation and the vessel names.","Manual reading served as the gold standard."],"must_hold":["Images come from CT scanners with 64 or more rows and meet CTA examination standards.","Patients do not have acute chest pain, diffuse coronary calcification or a history of percutaneous coronary intervention or bypass surgery.","Trained doctors use the prompts and do not base a clinical decision on the software alone."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"06c476f3ff14d384a83af054554a15c56143a184ae25d0087a182684679d19c1"}