{"id":"AIBD-1089","title":"China's CMDE finds that AI-SONIC-TH flagged patients with thyroid nodules of TI-RADS 4 or higher with 97.07% sensitivity in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, AI-SONIC-TH flagged patients with thyroid nodules of TI-RADS 4 or higher with 97.07% sensitivity and 90.54% specificity.","date_observed":"2023-11-03","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Zhejiang Deshang Yunxing Medical Technology built AI-SONIC-TH, software for thyroid ultrasound images. After a sonographer outlines a nodule by hand, a deep-learning algorithm flags whether it is suspected ACR TI-RADS category 4 or higher. 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 study of 1,043 patients at three sites in China. Per patient, the software alone reached 97.07% sensitivity (95% CI 95.06% to 98.28%) and 90.54% specificity (87.91% to 92.64%). Both lower bounds exceeded the targets, which the report does not give. Doctors reading with the software reached 94.82% sensitivity and 88.68% specificity. The report gives no figures for doctors reading alone, and it does not name the reference standard. On 3 November 2023, CMDE concluded 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). 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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：甲状腺结节超声影像辅助诊断软件（CQZ2200673）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf","date":"2023-11-03","written_by":"independent","quote":"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 sonographer outlined each nodule by hand on a grayscale ultrasound image imported into the software.","The deep-learning algorithm estimated the probability of each ACR TI-RADS category and suggested category 3 or lower or category 4 or higher."],"must_hold":["Patients have had no thyroid nodule surgery, ablation, radiotherapy or chemotherapy.","Images come from the specified ultrasound devices and probes.","Sonographers make the final imaging diagnosis, and clinicians do not decide on the software's result alone."],"echoes":[]},"paired_incident":null,"headline":"*AI-SONIC-TH* flagged suspicious thyroid nodules in China's review","metric":"97.07% sensitivity and 90.54% specificity","comparator":{"against":"Targets for the lower 95% confidence bounds of per-patient sensitivity and specificity (the report does not give the values)","before":null,"after":"Sensitivity 97.07% (95%CI：95.06%，98.28%) and specificity 90.54% (95%CI：87.91%，92.64%) per patient","basis":"measured","quote":"以患者为单位，器械独立阅片的灵敏度为97.07%（95%CI：95.06%，98.28%） ，特异度为 90.54%（95%CI：87.91%，92.64%） ，95%置信区间下限均大于目标值","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The accuracy 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/1710381379631085314.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2200673, applicant 浙江德尚韵兴医疗科技有限公司. 3 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：甲状腺结节超声影像辅助诊断软件（CQZ2200673）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf","date":"2023-11-03","written_by":"independent","quote":"以患者为单位，器械独立阅片的灵敏度为97.07%（95%CI：95.06%，98.28%） ，特异度为 90.54%（95%CI：87.91%，92.64%） ，95%置信区间下限均大于目标值"},{"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2200673, applicant 浙江德尚韵兴医疗科技有限公司. 3 November 2023. 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：甲状腺结节超声影像辅助诊断软件（CQZ2200673）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf","date":"2023-11-03","written_by":"independent","quote":"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-1089-source-0001","AIBD-1089-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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2200673, applicant 浙江德尚韵兴医疗科技有限公司. 3 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：甲状腺结节超声影像辅助诊断软件（CQZ2200673）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf","date":"2023-11-03","written_by":"independent","quote":"以患者为单位，器械独立阅片的灵敏度为97.07%（95%CI：95.06%，98.28%） ，特异度为 90.54%（95%CI：87.91%，92.64%） ，95%置信区间下限均大于目标值"},{"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2200673, applicant 浙江德尚韵兴医疗科技有限公司. 3 November 2023. 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：甲状腺结节超声影像辅助诊断软件（CQZ2200673）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710381379631085314.pdf","date":"2023-11-03","written_by":"independent","quote":"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[].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, AI-SONIC-TH flagged patients with thyroid nodules of TI-RADS 4 or higher with 97.07% sensitivity and 90.54% specificity.","account":"Zhejiang Deshang Yunxing Medical Technology built AI-SONIC-TH, software for thyroid ultrasound images. After a sonographer outlines a nodule by hand, a deep-learning algorithm flags whether it is suspected ACR TI-RADS category 4 or higher. 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 study of 1,043 patients at three sites in China. Per patient, the software alone reached 97.07% sensitivity (95% CI 95.06% to 98.28%) and 90.54% specificity (87.91% to 92.64%). Both lower bounds exceeded the targets, which the report does not give. Doctors reading with the software reached 94.82% sensitivity and 88.68% specificity. The report gives no figures for doctors reading alone, and it does not name the reference standard. On 3 November 2023, CMDE concluded 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). 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After a sonographer outlines a nodule by hand, a deep-learning algorithm flags whether it is suspected ACR TI-RADS category 4 or higher. 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 study of 1,043 patients at three sites in China. Per patient, the software alone reached 97.07% sensitivity (95% CI 95.06% to 98.28%) and 90.54% specificity (87.91% to 92.64%). Both lower bounds exceeded the targets, which the report does not give. Doctors reading with the software reached 94.82% sensitivity and 88.68% specificity. The report gives no figures for doctors reading alone, and it does not name the reference standard. On 3 November 2023, CMDE concluded 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.","replication":{"produced_by":["A sonographer outlined each nodule by hand on a grayscale ultrasound image imported into the software.","The deep-learning algorithm estimated the probability of each ACR TI-RADS category and suggested category 3 or lower or category 4 or higher."],"must_hold":["Patients have had no thyroid nodule surgery, ablation, radiotherapy or chemotherapy.","Images come from the specified ultrasound devices and probes.","Sonographers make the final imaging diagnosis, and clinicians do not decide on the software's result 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":"c9974822ca95e88fca601f55abcebeeaa9264fb88cb0648ac4ce5ef6a2f4f283"}