{"id":"AIBD-1086","title":"China's CMDE finds that Infervision's IR-CT-PE flagged pulmonary embolism with 92.27% sensitivity and 96.91% specificity in the maker's trial","summary":"In the maker's two-site trial that China's CMDE reviewed, Infervision's IR-CT-PE flagged pulmonary embolism with 92.27% sensitivity and 96.91% specificity, above 80% targets.","date_observed":"2025-02-19","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Infervision Medical Technology built IR-CT-PE, software that uses deep learning to segment the airways, pulmonary vessels, lung lobes and emboli on pulmonary CT angiography. It flags adults with suspected acute pulmonary embolism for triage. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a multicenter, single-arm study of 485 cases at two institutions. An expert panel's case judgments served as the reference. Sensitivity was 92.27% (95% CI 87.57% to 95.61%) and specificity 96.91% (95% CI 94.21% to 98.58%), both above targets of 80%. The software's median time to a result was 167.0 seconds. The hospitals' routine imaging reports took a median of 55431.0 seconds, about 15.4 hours. No software fault or adverse event occurred. On 19 February 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. 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CQZ2400926, applicant 推想医疗科技股份有限公司. 19 February 2025. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：肺栓塞CT血管造影图像辅助分诊软件（CQZ2400926）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1740618990620049428.pdf","date":"2025-02-19","written_by":"independent","quote":"经综合评价，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}],"replication":{"produced_by":["The software segmented the airways, pulmonary vessels, lung lobes and emboli with deep learning and gave a triage prompt for suspected acute pulmonary embolism.","An expert panel's case judgments served as the reference."],"must_hold":["Patients are adults with suspected acute pulmonary embolism.","Trained physicians use the prompt and do not base a clinical decision on it alone."],"echoes":[]},"paired_incident":null,"headline":"*IR-CT-PE* flagged pulmonary embolism in a two-site trial in China","metric":"92.27% sensitivity and 96.91% specificity","comparator":{"against":"Preset targets of 80%, with an expert panel's case judgments as the reference","before":"Targets of 80% for sensitivity and for specificity","after":"92.27% sensitivity and 96.91% specificity","basis":"measured","quote":"软件的分诊灵敏度 92.27%（95%CI，87.57%-95.61%），区间下限大于目标值 80%，p <0.0001。以专家组的病例判定为参考，评价软件分诊功能验证中与专家组一致的阴性病例比率，及与专家组不一致的病例。软件的分诊特异度为 96.91%（95%CI，94.21%-98.58%），区间下限大于目标值 80%，p <0.0001。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1740618990620049428.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The accuracy and speed were measured in the maker's pre-market trial, and the report gives no outcome of 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/1740618990620049428.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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