{"id":"AIBD-0962","title":"China's CMDE finds that dentists reading panoramic X-rays with DC-OPGAI-01 found more decayed teeth in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, 12 dentists using DC-OPGAI-01 detected caries with a tooth-level sensitivity of 82.40%, against 67.43% without it.","date_observed":"2025-02-13","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Beijing Yuyi Ganlan Information Technology built DC-OPGAI-01, software that uses deep learning to identify teeth with suspected caries on panoramic radiographs of adults. 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 retrospective randomized crossover multi-reader multi-case study of 402 subjects at three sites. Each of 12 dentists read every case with and without the software. Tooth-level sensitivity for caries was 82.40% with the software and 67.43% without, a difference of 14.97% (95% CI 7.28% to 22.66%). Specificity was 97.37% against 97.16%, which met the non-inferiority margin. Reading took 50.3677 seconds per case with the software and 65.1161 seconds without. On 13 February 2025, CMDE concluded 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 approval. The dentists read stored images, so the software guided no care. The report does not state the reference standard for caries.","category":"aggregate result","unexpected":false,"purpose":"Beijing Yuyi Ganlan Information Technology built DC-OPGAI-01 to identify teeth with suspected caries on panoramic radiographs of adults.","system":"DC-OPGAI-01 (龋病口腔曲面体层图像辅助检测软件)","model_version":"Release 1 (full version 1.0.0)","developer":"Beijing Yuyi Ganlan Information Technology Co., Ltd. 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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：龋病口腔曲面体层图像辅助检测软件（CQZ2400448）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1740036818606034537.pdf","date":"2025-02-13","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。"}],"replication":{"produced_by":["The software analyzed panoramic radiographs with deep learning and marked the positions of teeth with suspected caries.","Twelve dentists read 402 stored cases with and without the marks in a randomized crossover design."],"must_hold":["Patients are adults aged 18 or over.","Trained dental clinicians make the diagnosis and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*DC-OPGAI-01* helped dentists find more tooth decay on X-rays","metric":"a tooth-level sensitivity of 82.40%, against 67.43% without it","comparator":{"against":"The same 12 dentists reading the same radiographs without the software","before":"67.43% tooth-level sensitivity","after":"82.40% tooth-level sensitivity","basis":"measured","quote":"组间差值为 14.97%，95%置信区间为（7.28%，22.66%），下限优于优效界值 0，优效性假设成立","url":"https://www.cmde.org.cn/directory/web/cmde/images/1740036818606034537.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/1740036818606034537.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：龋病口腔曲面体层图像辅助检测软件（CQZ2400448）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1740036818606034537.pdf","date":"2025-02-13","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。"}]}},"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-0962-source-0001","AIBD-0962-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：龋病口腔曲面体层图像辅助检测软件 (technical review report for the registration of dental caries panoramic radiograph detection-aid software), acceptance no. 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