{"id":"AIBD-1073","title":"China's CMDE finds that Tencent's MY-YD-01 fundus software raised detection of glaucoma-like optic nerve damage in the maker's trial","summary":"In Tencent's trial of 1,092 subjects that China's CMDE reviewed, the trial group's sensitivity for glaucoma-like optic nerve changes exceeded the control group's by 16.42%.","date_observed":"2022-08-29","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Tencent Healthcare (Shenzhen) built MY-YD-01, software that analyzes a single non-mydriatic color fundus photograph with deep learning modules. They check image quality and segment the optic disc and cup. The software then flags suspected chronic glaucoma-like optic neuropathy and suggests whether the patient needs further examination. 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, with 1,092 subjects at four institutions. It compared a trial group with a control group, and the report does not describe how each group read the photographs. Subject-level sensitivity was higher in the trial group by 16.42% (95% CI 3.09% to 28.97%), and specificity met the non-inferiority test. The report adds that the software alone had fewer false positives and false negatives than either group. On 29 August 2022, CMDE judged that “该产品受益大于风险” (the product's benefits outweigh its risks) and recommended approval. It lists doctors' overreliance on the software as a risk, and the software is not for people with high myopia.","category":"aggregate result","unexpected":false,"purpose":"Tencent Healthcare (Shenzhen) built MY-YD-01 to flag suspected chronic glaucoma-like optic neuropathy on fundus photographs of adults and suggest whether they need further examination.","system":"MY-YD-01 (慢性青光眼样视神经病变眼底图像辅助诊断软件)","model_version":"Release V1","developer":"Tencent Healthcare (Shenzhen) Co., Ltd. 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The report does not describe either group, and the trial was the maker's own."},"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：慢性青光眼样视神经病变眼底图像辅助诊断软件 (technical review report for the registration of fundus image diagnosis-aid software for chronic glaucoma-like optic neuropathy), acceptance no. CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 三、临床评价概述 (clinical evaluation), p. 7.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","written_by":"independent","quote":"受试者水平检出灵敏度，FAS 及 PPS 集的试验组与对照组差值分别为16.42% （ 95%CI ： 3.09%-28.97% ） 和 18.97% （ 95%CI ：3.60%-33.08%） ，均满足优效性验证。"},{"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：慢性青光眼样视神经病变眼底图像辅助诊断软件 (technical review report for the registration of fundus image diagnosis-aid software for chronic glaucoma-like optic neuropathy), acceptance no. CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","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，认为该产品受益大于风险。"}],"replication":{"produced_by":["Deep learning modules checked image quality, segmented the optic disc and cup and classified each accepted photograph.","The software fused the predictions of a disc-and-cup model and a whole-image model into one prompt."],"must_hold":["Photographs are single non-mydriatic color fundus images of about 45 degrees from a specified camera that pass the software's quality check.","Patients are adults, and people with high myopia are excluded.","Doctors qualified for fundus examination make the decision and do not rely on the prompt alone."],"echoes":[]},"paired_incident":null,"headline":"*MY-YD-01* raised detection of glaucoma-like damage on fundus photos","metric":"exceeded the control group's by 16.42%","comparator":{"against":"The control group of the same trial (the report does not describe how either group read the photographs)","before":null,"after":"Subject-level sensitivity higher by 16.42% (FAS) and 18.97% (PPS) in the trial group","basis":"measured","quote":"受试者水平检出灵敏度，FAS 及 PPS 集的试验组与对照组差值分别为16.42% （ 95%CI ： 3.09%-28.97% ） 和 18.97% （ 95%CI ：3.60%-33.08%） ，均满足优效性验证。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.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 the report gives 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/1663555091904022046.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 三、临床评价概述 (clinical evaluation), p. 7.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","written_by":"independent","quote":"受试者水平检出灵敏度，FAS 及 PPS 集的试验组与对照组差值分别为16.42% （ 95%CI ： 3.09%-28.97% ） 和 18.97% （ 95%CI ：3.60%-33.08%） ，均满足优效性验证。"},{"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：慢性青光眼样视神经病变眼底图像辅助诊断软件 (technical review report for the registration of fundus image diagnosis-aid software for chronic glaucoma-like optic neuropathy), acceptance no. CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","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-1073-source-0001","AIBD-1073-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：慢性青光眼样视神经病变眼底图像辅助诊断软件 (technical review report for the registration of fundus image diagnosis-aid software for chronic glaucoma-like optic neuropathy), acceptance no. CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 三、临床评价概述 (clinical evaluation), p. 7.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","written_by":"independent","quote":"受试者水平检出灵敏度，FAS 及 PPS 集的试验组与对照组差值分别为16.42% （ 95%CI ： 3.09%-28.97% ） 和 18.97% （ 95%CI ：3.60%-33.08%） ，均满足优效性验证。"},{"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：慢性青光眼样视神经病变眼底图像辅助诊断软件 (technical review report for the registration of fundus image diagnosis-aid software for chronic glaucoma-like optic neuropathy), acceptance no. CQZ2100700, applicant 腾讯医疗健康（深圳）有限公司. 29 August 2022. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：慢性青光眼样视神经病变眼底图像辅助诊断软件（CQZ2100700）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1663555091904022046.pdf","date":"2022-08-29","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[].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 Tencent's trial of 1,092 subjects that China's CMDE reviewed, the trial group's sensitivity for glaucoma-like optic nerve changes exceeded the control group's by 16.42%.","account":"Tencent Healthcare (Shenzhen) built MY-YD-01, software that analyzes a single non-mydriatic color fundus photograph with deep learning modules. They check image quality and segment the optic disc and cup. The software then flags suspected chronic glaucoma-like optic neuropathy and suggests whether the patient needs further examination. 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, with 1,092 subjects at four institutions. It compared a trial group with a control group, and the report does not describe how each group read the photographs. Subject-level sensitivity was higher in the trial group by 16.42% (95% CI 3.09% to 28.97%), and specificity met the non-inferiority test. The report adds that the software alone had fewer false positives and false negatives than either group. On 29 August 2022, CMDE judged that “该产品受益大于风险” (the product's benefits outweigh its risks) and recommended approval. 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They check image quality and segment the optic disc and cup. The software then flags suspected chronic glaucoma-like optic neuropathy and suggests whether the patient needs further examination. 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, with 1,092 subjects at four institutions. It compared a trial group with a control group, and the report does not describe how each group read the photographs. Subject-level sensitivity was higher in the trial group by 16.42% (95% CI 3.09% to 28.97%), and specificity met the non-inferiority test. The report adds that the software alone had fewer false positives and false negatives than either group. On 29 August 2022, CMDE judged that “该产品受益大于风险” (the product's benefits outweigh its risks) and recommended approval. 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