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It used stored images of 490 cases at Beijing Friendship Hospital and Ningbo Hwa Mei Hospital, with an expert panel's results as the reference. Lesion-level sensitivity was 94.83% and case-level specificity was 91.60%, with the lower bounds of their 95% confidence intervals above targets of 88.4% and 81%. Judgments took a median of 7.47 minutes with the software and 9.45 minutes for the expert panel, a statistically significant difference. On 22 November 2023, CMDE judged 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 registration. The time comparison is with the panel that set the reference standard, so it does not isolate the software. 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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：肝脏局灶性病变MR图像辅助分诊软件（CQZ2201476）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664577098001803.pdf","date":"2023-11-22","written_by":"independent","quote":"试验组与专家组判定时间，FAS分析集，软件判定时间中位数 7.47min，专家组判定时间中位数 9.45min，软件判定时间小于专家组判定时间，P<0.0001，两组差值有统计学意义"}],"replication":{"produced_by":["The software extracted liver segments from MR images with deep learning and detected suspected focal lesions in them.","It listed the cases with suspected lesions, and doctors could add, delete or edit lesions before a text report was made.","An expert panel's results served as the reference standard."],"must_hold":["Patients are adults, and the lesions are 5 mm or larger.","Trained doctors use the results as a reference and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*LiverMRDoc* reached liver MRI judgments faster in China's review","metric":"a median of 7.47 minutes with LiverMRDoc, against 9.45 minutes for an expert panel","comparator":{"against":"The expert panel that set the reference standard, reading the same 490 cases","before":"median 9.45min for the expert panel","after":"median 7.47min with the software","basis":"measured","quote":"试验组与专家组判定时间，FAS分析集，软件判定时间中位数 7.47min，专家组判定时间中位数 9.45min，软件判定时间小于专家组判定时间，P<0.0001，两组差值有统计学意义","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664577098001803.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured on stored images 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/1743664577098001803.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2201476, applicant 语坤（北京）网络科技有限公司. 22 November 2023. 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：肝脏局灶性病变MR图像辅助分诊软件（CQZ2201476）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664577098001803.pdf","date":"2023-11-22","written_by":"independent","quote":"试验组与专家组判定时间，FAS分析集，软件判定时间中位数 7.47min，专家组判定时间中位数 9.45min，软件判定时间小于专家组判定时间，P<0.0001，两组差值有统计学意义"}]}},"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-1075-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：肝脏局灶性病变MR图像辅助分诊软件 (technical review report for the registration of focal liver lesion MR image triage-aid software), acceptance no. CQZ2201476, applicant 语坤（北京）网络科技有限公司. 22 November 2023. 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：肝脏局灶性病变MR图像辅助分诊软件（CQZ2201476）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664577098001803.pdf","date":"2023-11-22","written_by":"independent","quote":"试验组与专家组判定时间，FAS分析集，软件判定时间中位数 7.47min，专家组判定时间中位数 9.45min，软件判定时间小于专家组判定时间，P<0.0001，两组差值有统计学意义"}]}},"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, judgments on liver MRI took a median of 7.47 minutes with LiverMRDoc, against 9.45 minutes for an expert panel.","account":"Yukun (Beijing) Network Technology built LiverMRDoc, software that uses deep learning to outline liver segments on MRI and detect suspected focal lesions of 5 mm or more. It lists the cases with lesions so that doctors can triage them. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration. The trial was the maker's. It used stored images of 490 cases at Beijing Friendship Hospital and Ningbo Hwa Mei Hospital, with an expert panel's results as the reference. Lesion-level sensitivity was 94.83% and case-level specificity was 91.60%, with the lower bounds of their 95% confidence intervals above targets of 88.4% and 81%. Judgments took a median of 7.47 minutes with the software and 9.45 minutes for the expert panel, a statistically significant difference. On 22 November 2023, CMDE judged 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 registration. The time comparison is with the panel that set the reference standard, so it does not isolate the software. CMDE notes that false negatives could delay treatment."}},"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 2.0.1.001)"}},"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":"LiverMRDoc (肝脏局灶性病变MR图像辅助分诊软件)"}},"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 LiverMRDoc met its liver MRI accuracy targets and reached judgments faster than an expert panel in the maker's trial","headline":"*LiverMRDoc* reached liver MRI judgments faster 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":["5b25a0f1647dd45ebba47004a736886d28c4288e811dfca51269f469e572d78a"],"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 LiverMRDoc, software that uses deep learning to outline liver segments on MRI and detect suspected focal lesions of 5 mm or more. It lists the cases with lesions so that doctors can triage them. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration. The trial was the maker's. It used stored images of 490 cases at Beijing Friendship Hospital and Ningbo Hwa Mei Hospital, with an expert panel's results as the reference. Lesion-level sensitivity was 94.83% and case-level specificity was 91.60%, with the lower bounds of their 95% confidence intervals above targets of 88.4% and 81%. Judgments took a median of 7.47 minutes with the software and 9.45 minutes for the expert panel, a statistically significant difference. On 22 November 2023, CMDE judged 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 registration. The time comparison is with the panel that set the reference standard, so it does not isolate the software. CMDE notes that false negatives could delay treatment.","replication":{"produced_by":["The software extracted liver segments from MR images with deep learning and detected suspected focal lesions in them.","It listed the cases with suspected lesions, and doctors could add, delete or edit lesions before a text report was made.","An expert panel's results served as the reference standard."],"must_hold":["Patients are adults, and the lesions are 5 mm or larger.","Trained doctors use the results as a reference 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":"364bbce60140a41d8398dae7cbba4a254d0967b262ee212990ffb8ef22f19b6e"}