{"id":"AIBD-1077","title":"China's CMDE finds that Yitu_AICare_Bone_Age met its bone-age error target in the maker's trial and judges that it makes reading more efficient","summary":"In the maker's trial of 1,000 subjects that China's CMDE reviewed, Yitu_AICare_Bone_Age gave TW3 bone ages within its error target against an expert panel. The report gives no figures.","date_observed":"2021-03-15","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Hangzhou Yitu Healthcare Technology built Yitu_AICare_Bone_Age, software that locates ossification centers on hand and wrist X-rays with deep learning and calculates bone age by the TW3 method. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as a priority device. The trial was the maker's. It was prospective and enrolled 1,000 subjects at four clinical institutions. An expert panel's TW3-RUS and TW3-Carpal bone ages served as the gold standard. The report says that the software's mean absolute error against the panel reached the preset target. It gives no figures. CMDE judged that the product “能够有效提高医师阅片效率” (can effectively improve doctors' reading efficiency) when its clinical performance meets clinical needs. On 15 March 2021, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE warns that accuracy may be lower for people aged 0.5 to 6 and 13 to 18, who were few in the trial. 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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：儿童手部X射线影像骨龄辅助评估软件（CQZ2000273）","url":"https://www.cmde.org.cn/directory/web/cmde/images/tvnNr8rWsr9YyeTP39OwzG5x8HkuKjW+sbAucDI7bz+o6hDUVoyMDAwMjczo6lzLnBkZg==.pdf","date":"2021-03-15","written_by":"independent","quote":"在临床性能满足临床需求的基础上，能够有效提高医师阅片效率"}],"replication":{"produced_by":["The software located ossification centers on hand and wrist X-rays with deep learning.","It calculated TW3-RUS and TW3-Carpal bone ages.","An expert panel's TW3 bone ages served as the gold standard."],"must_hold":["Patients are aged 0.5 to 18 and do not have cone-shaped or deformed epiphyses.","Trained doctors use the result and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*Yitu_AICare_Bone_Age* met its bone-age error target in China's review","metric":null,"comparator":{"against":"An expert panel's TW3-RUS and TW3-Carpal bone ages as the gold standard, with a preset error target","before":"Expert panel's TW3 bone ages (the gold standard)","after":"Mean absolute error within the preset target (no figures given)","basis":"measured","quote":"试验器械的TW3-RUS和TW3-Carpal骨龄诊断结果与金标准诊断结果的绝对误差均值达到预期目标","url":"https://www.cmde.org.cn/directory/web/cmde/images/tvnNr8rWsr9YyeTP39OwzG5x8HkuKjW+sbAucDI7bz+o6hDUVoyMDAwMjczo6lzLnBkZg==.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The trial measured agreement with an expert panel, and the report gives no figures and 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/tvnNr8rWsr9YyeTP39OwzG5x8HkuKjW+sbAucDI7bz+o6hDUVoyMDAwMjczo6lzLnBkZg==.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).","title":"医疗器械产品注册技术审评报告：儿童手部X射线影像骨龄辅助评估软件（CQZ2000273）","url":"https://www.cmde.org.cn/directory/web/cmde/images/tvnNr8rWsr9YyeTP39OwzG5x8HkuKjW+sbAucDI7bz+o6hDUVoyMDAwMjczo6lzLnBkZg==.pdf","date":"2021-03-15","written_by":"independent","quote":"在临床性能满足临床需求的基础上，能够有效提高医师阅片效率"}]}},"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-1077-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：儿童手部X射线影像骨龄辅助评估软件 (technical review report for the registration of pediatric hand X-ray bone age assessment-aid software), acceptance no. CQZ2000273, applicant 杭州依图医疗技术有限公司. 15 March 2021. 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：儿童手部X射线影像骨龄辅助评估软件（CQZ2000273）","url":"https://www.cmde.org.cn/directory/web/cmde/images/tvnNr8rWsr9YyeTP39OwzG5x8HkuKjW+sbAucDI7bz+o6hDUVoyMDAwMjczo6lzLnBkZg==.pdf","date":"2021-03-15","written_by":"independent","quote":"在临床性能满足临床需求的基础上，能够有效提高医师阅片效率"}]}},"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 of 1,000 subjects that China's CMDE reviewed, Yitu_AICare_Bone_Age gave TW3 bone ages within its error target against an expert panel. The report gives no figures.","account":"Hangzhou Yitu Healthcare Technology built Yitu_AICare_Bone_Age, software that locates ossification centers on hand and wrist X-rays with deep learning and calculates bone age by the TW3 method. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as a priority device. The trial was the maker's. It was prospective and enrolled 1,000 subjects at four clinical institutions. An expert panel's TW3-RUS and TW3-Carpal bone ages served as the gold standard. The report says that the software's mean absolute error against the panel reached the preset target. It gives no figures. CMDE judged that the product “能够有效提高医师阅片效率” (can effectively improve doctors' reading efficiency) when its clinical performance meets clinical needs. On 15 March 2021, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE warns that accuracy may be lower for people aged 0.5 to 6 and 13 to 18, who were few in the trial. It adds that accuracy may be lower for ethnic minorities, because the algorithm work was mainly based on Han Chinese people."}},"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 (full version 2.2.0)"}},"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":"Yitu_AICare_Bone_Age (儿童手部X射线影像骨龄辅助评估软件)"}},"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 Yitu_AICare_Bone_Age met its bone-age error target in the maker's trial and judges that it makes reading more efficient","headline":"*Yitu_AICare_Bone_Age* met its bone-age error target 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":["7be8a44804b90dcac5a15f7773d47d7e3c1b02c4a7ec6980d204c504142adff9"],"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":"Hangzhou Yitu Healthcare Technology built Yitu_AICare_Bone_Age, software that locates ossification centers on hand and wrist X-rays with deep learning and calculates bone age by the TW3 method. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as a priority device. The trial was the maker's. It was prospective and enrolled 1,000 subjects at four clinical institutions. An expert panel's TW3-RUS and TW3-Carpal bone ages served as the gold standard. The report says that the software's mean absolute error against the panel reached the preset target. It gives no figures. CMDE judged that the product “能够有效提高医师阅片效率” (can effectively improve doctors' reading efficiency) when its clinical performance meets clinical needs. On 15 March 2021, it found that the benefits outweigh the risks and recommended registration. The trial did not time the reading. CMDE warns that accuracy may be lower for people aged 0.5 to 6 and 13 to 18, who were few in the trial. It adds that accuracy may be lower for ethnic minorities, because the algorithm work was mainly based on Han Chinese people.","replication":{"produced_by":["The software located ossification centers on hand and wrist X-rays with deep learning.","It calculated TW3-RUS and TW3-Carpal bone ages.","An expert panel's TW3 bone ages served as the gold standard."],"must_hold":["Patients are aged 0.5 to 18 and do not have cone-shaped or deformed epiphyses.","Trained doctors use the result 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":"a5b5d84e70e01ebba2fca3cd4090389bb19c8d95a2abc26b2a56d57d3c6b8d9d"}