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Imaging experts' readings served as the reference. With the software, lesion-level sensitivity rose by 10.85% (95% CI 7.77% to 13.94%) and patient-level sensitivity by 8.55%. Patient-level specificity fell by 2.96%, within the non-inferiority margin of -10%. On 26 February 2024, CMDE concluded that “该产品上市带来的受益大于风险” (putting the product on the market brings benefits that outweigh the risks). It recommended approval. In a notice dated 1 March 2024, NMPA announced that it had approved the product as an innovative device. 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Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：颅内动脉瘤CT造影图像辅助检测软件（CQZ2301114）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1714024440043003676.pdf","date":"2024-02-26","written_by":"independent","quote":"FAS人群中试验组与对照组动脉瘤检出敏感度 （以病灶为单位）之差及 95%CI 为 10.85%（7.77%, 13.94%），其下限大于 0。"},{"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：颅内动脉瘤CT造影图像辅助检测软件 (technical review report for the registration of intracranial aneurysm detection-aid software for CT angiography images), acceptance no. CQZ2301114, applicant 杭州深睿博联科技有限公司. 26 February 2024. Benefit-risk determination and overall opinion, CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：颅内动脉瘤CT造影图像辅助检测软件（CQZ2301114）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1714024440043003676.pdf","date":"2024-02-26","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。"},{"kind":"regulatory document","citation":"National Medical Products Administration (NMPA), China. CT Image-aided Detection Software for Intracranial Aneurysms Approved for Marketing. 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