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It used stored scans of 600 subjects, 299 with bleeding and 301 without, from three centers, with senior doctors' readings as the reference. The triage flags reached a sensitivity of 97.32% and a specificity of 99.67%, with the lower bounds of their 95% confidence intervals above targets of 90%. CMDE judged that the product “可提高颅内出血患者的筛选效率” (can make screening of patients with intracranial hemorrhage more efficient). On 4 March 2022, it found that the clinical benefits outweigh the risks and recommended registration. The trial did not time the screening, so the gain in efficiency is CMDE's judgment. 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Section 四、产品受益风险判定 (benefit-risk determination).","title":"医疗器械产品注册技术审评报告：颅内出血CT影像辅助分诊软件（CQZ2100676）","url":"https://www.cmde.org.cn/directory/web/cmde/images/wq3E2rP20apDVNOwzG4qNb6t9bV78jtvP6jqENRWjIxMDA2NzajqS5wZGY=.pdf","date":"2022-03-04","written_by":"independent","quote":"该产品临床主要受益为：可对颅脑 CT平扫影像进行显示、处理和分析，用于对超急性期、急性期颅内出血患者的分诊提示，可提高颅内出血患者的筛选效率。"}],"replication":{"produced_by":["The software analyzed non-contrast head CT on a server with a deep learning image processing module.","It gave triage prompts for hyperacute and acute intracranial hemorrhage and quantified the volume of suspected bleeding.","Senior doctors' readings served as the reference standard."],"must_hold":["Images are non-contrast head CT.","Trained doctors use the prompts and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*uAI-HematomaCare* flagged brain bleeds on CT in China's review","metric":"a sensitivity of 97.32% and a specificity of 99.67%","comparator":{"against":"Target values of 90% for sensitivity and specificity, with senior doctors' readings as the reference","before":"target value 90%","after":"sensitivity 97.32% (95%CI: 94.80%, 98.84%) and specificity 99.67% (95%CI:98.16%, 99.99%)","basis":"measured","quote":"产品辅助分诊敏感度为 97.32%（95%CI: 94.80%, 98.84%），敏感度 95％置信区间下限高于目标值 90%, p<0.001；特异度为 99.67%（95%CI:98.16%, 99.99%），特异度 95％置信区间下限高于目标值 90%, p<0.001","url":"https://www.cmde.org.cn/directory/web/cmde/images/wq3E2rP20apDVNOwzG4qNb6t9bV78jtvP6jqENRWjIxMDA2NzajqS5wZGY=.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The trial measured accuracy on stored scans 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/wq3E2rP20apDVNOwzG4qNb6t9bV78jtvP6jqENRWjIxMDA2NzajqS5wZGY=.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2100676, applicant 上海联影智能医疗科技有限公司. 4 March 2022. Section 四、产品受益风险判定 (benefit-risk determination).","title":"医疗器械产品注册技术审评报告：颅内出血CT影像辅助分诊软件（CQZ2100676）","url":"https://www.cmde.org.cn/directory/web/cmde/images/wq3E2rP20apDVNOwzG4qNb6t9bV78jtvP6jqENRWjIxMDA2NzajqS5wZGY=.pdf","date":"2022-03-04","written_by":"independent","quote":"该产品临床主要受益为：可对颅脑 CT平扫影像进行显示、处理和分析，用于对超急性期、急性期颅内出血患者的分诊提示，可提高颅内出血患者的筛选效率。"}]}},"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-1076-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：颅内出血CT影像辅助分诊软件 (technical review report for the registration of intracranial hemorrhage CT image triage-aid software), acceptance no. CQZ2100676, applicant 上海联影智能医疗科技有限公司. 4 March 2022. Section 四、产品受益风险判定 (benefit-risk determination).","title":"医疗器械产品注册技术审评报告：颅内出血CT影像辅助分诊软件（CQZ2100676）","url":"https://www.cmde.org.cn/directory/web/cmde/images/wq3E2rP20apDVNOwzG4qNb6t9bV78jtvP6jqENRWjIxMDA2NzajqS5wZGY=.pdf","date":"2022-03-04","written_by":"independent","quote":"该产品临床主要受益为：可对颅脑 CT平扫影像进行显示、处理和分析，用于对超急性期、急性期颅内出血患者的分诊提示，可提高颅内出血患者的筛选效率。"}]}},"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 that China's CMDE reviewed, uAI-HematomaCare flagged acute brain bleeds on stored head CT of 600 subjects with a sensitivity of 97.32% and a specificity of 99.67%.","account":"Shanghai United Imaging Intelligence built uAI-HematomaCare, deep learning software that reads non-contrast head CT and flags hyperacute and acute intracranial hemorrhage for triage. It also measures the volume of suspected bleeding. 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 used stored scans of 600 subjects, 299 with bleeding and 301 without, from three centers, with senior doctors' readings as the reference. The triage flags reached a sensitivity of 97.32% and a specificity of 99.67%, with the lower bounds of their 95% confidence intervals above targets of 90%. CMDE judged that the product “可提高颅内出血患者的筛选效率” (can make screening of patients with intracranial hemorrhage more efficient). On 4 March 2022, it found that the clinical benefits outweigh the risks and recommended registration. The trial did not time the screening, so the gain in efficiency is CMDE's judgment. 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It also measures the volume of suspected bleeding. 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 used stored scans of 600 subjects, 299 with bleeding and 301 without, from three centers, with senior doctors' readings as the reference. The triage flags reached a sensitivity of 97.32% and a specificity of 99.67%, with the lower bounds of their 95% confidence intervals above targets of 90%. CMDE judged that the product “可提高颅内出血患者的筛选效率” (can make screening of patients with intracranial hemorrhage more efficient). On 4 March 2022, it found that the clinical benefits outweigh the risks and recommended registration. The trial did not time the screening, so the gain in efficiency is CMDE's judgment. CMDE notes that false negatives could delay diagnosis and treatment.","replication":{"produced_by":["The software analyzed non-contrast head CT on a server with a deep learning image processing module.","It gave triage prompts for hyperacute and acute intracranial hemorrhage and quantified the volume of suspected bleeding.","Senior doctors' readings served as the reference standard."],"must_hold":["Images are non-contrast head CT.","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":"fa02c41407ed809ff5681cbd3fde5a873783944b8f0b19831be5d197d37d634e"}