{"id":"AIBD-0961","title":"China's CMDE finds that less senior sonographers detected breast lesions more accurately with Yizhun-DBU in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, six less senior readers detected breast lesions with an AFROC-AUC of 0.8785 using Yizhun-DBU, against 0.6500 alone.","date_observed":"2025-02-25","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Beijing Yizhun Medical Technology built Yizhun-DBU, software that uses deep learning to mark suspected breast masses over 5 mm in real time in the video from an ultrasound scanner. 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 prospective multi-reader multi-case crossover study of 176 subjects at three sites. Six mid- and junior-level readers read every case with and without the software, and three senior readers set the reference. The AFROC-AUC was 0.8785 with the software and 0.6500 without, a difference of 0.2285 (95% CI 0.2034 to 0.2535). The share of true lesion regions found rose by 28.4 percentage points. Specificity did not differ statistically, and the difference in sensitivity was borderline (p = 0.0507). On 25 February 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. 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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：乳腺超声影像辅助检测软件（CQZ2400392）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1741742380821028657.pdf","date":"2025-02-25","written_by":"independent","quote":"试验组的 AFROC-AUC 为 0.8785 (0.8471, 0.9100)，对照组的AFROC-AUC 为 0.6500(0.6268, 0.6733)"},{"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：乳腺超声影像辅助检测软件 (technical review report for the registration of breast ultrasound image detection-aid software), acceptance no. CQZ2400392, applicant 北京医准医疗科技有限公司. 25 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：乳腺超声影像辅助检测软件（CQZ2400392）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1741742380821028657.pdf","date":"2025-02-25","written_by":"independent","quote":"根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。"}],"replication":{"produced_by":["A video capture card fed the scanner's output to the software, which marked suspected masses in real time.","Six mid- and junior-level readers read each case with and without the marks."],"must_hold":["Patients are adult women without prior breast removal, ablation, radiotherapy, chemotherapy or implants.","Images come from the specified ultrasound devices and probes.","Sonographers judge each case from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]},"paired_incident":null,"headline":"*Yizhun-DBU* helped less senior sonographers find breast lesions","metric":"an AFROC-AUC of 0.8785 using Yizhun-DBU, against 0.6500 alone","comparator":{"against":"The same six readers reading the same cases without the software, with three senior readers as the reference","before":"AFROC-AUC 0.6500(0.6268, 0.6733)","after":"AFROC-AUC 0.8785 (0.8471, 0.9100)","basis":"measured","quote":"试验组的 AFROC-AUC 为 0.8785 (0.8471, 0.9100)，对照组的AFROC-AUC 为 0.6500(0.6268, 0.6733)，两组 AFROC 的差值的点估计为 0.2285，95%置信区间为(0.2034, 0.2535)","url":"https://www.cmde.org.cn/directory/web/cmde/images/1741742380821028657.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial 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/1741742380821028657.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 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：乳腺超声影像辅助检测软件（CQZ2400392）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1741742380821028657.pdf","date":"2025-02-25","written_by":"independent","quote":"根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。"}]}},"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-0961-source-0001","AIBD-0961-source-0002"],"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：乳腺超声影像辅助检测软件 (technical review report for the registration of breast ultrasound image detection-aid software), acceptance no. 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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 prospective multi-reader multi-case crossover study of 176 subjects at three sites. Six mid- and junior-level readers read every case with and without the software, and three senior readers set the reference. The AFROC-AUC was 0.8785 with the software and 0.6500 without, a difference of 0.2285 (95% CI 0.2034 to 0.2535). The share of true lesion regions found rose by 28.4 percentage points. Specificity did not differ statistically, and the difference in sensitivity was borderline (p = 0.0507). On 25 February 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. 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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 prospective multi-reader multi-case crossover study of 176 subjects at three sites. Six mid- and junior-level readers read every case with and without the software, and three senior readers set the reference. The AFROC-AUC was 0.8785 with the software and 0.6500 without, a difference of 0.2285 (95% CI 0.2034 to 0.2535). The share of true lesion regions found rose by 28.4 percentage points. Specificity did not differ statistically, and the difference in sensitivity was borderline (p = 0.0507). On 25 February 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The reference was the senior readers' judgment, and the report mentions no pathology.","replication":{"produced_by":["A video capture card fed the scanner's output to the software, which marked suspected masses in real time.","Six mid- and junior-level readers read each case with and without the marks."],"must_hold":["Patients are adult women without prior breast removal, ablation, radiotherapy, chemotherapy or implants.","Images come from the specified ultrasound devices and probes.","Sonographers judge each case from the images and the patient's condition and do not decide on the marks 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":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"dfd16346b4bf9083faf67e548ba8bf88a32307c39c1612827a61f79fafca07e1"}