{"id":"AIBD-1160","title":"China's CMDE finds that the BMP-10 monitor's sedation index matched sedation scores more often than BIS in the maker's trial","summary":"In the maker's trial of 140 patients that China's CMDE reviewed, the BMP-10 monitor's NSI agreed with sedation scores 90.62% of the time, more often than the BIS index.","date_observed":"2026-10-23","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Sichuan Xinyuan Bioelectronics Technology built the BMP-10 anesthesia depth monitor. It records EEG through six forehead electrodes and shows a sedation depth index, the NSI. The report says that the company submitted research on an EEG detection algorithm based on machine learning. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. For the NSI, the maker ran a prospective, multicenter, self-controlled trial with 140 patients at four clinical institutions. The reference standard was the MOAA/S sedation score. The NSI agreed with that score 90.62% of the time (95% CI 89.89% to 91.36%), which met the target. CMDE reports that the NSI agreed with MOAA/S more often than the BIS index did, a statistically significant difference. No patient had awareness during surgery, and no device-related adverse event occurred. CMDE concluded that “申请人提供的临床评价资料符合目前的临床审评要求” (the clinical evaluation data that the applicant provided meet current clinical review requirements). The report, posted on 23 October 2026, has no benefit-risk section and gives no figure for BIS.","category":"aggregate result","unexpected":false,"purpose":"Sichuan Xinyuan Bioelectronics Technology built the BMP-10 monitor to record EEG in patients aged one and over and to show an index of sedation depth for adults under anesthesia.","system":"BMP-10 anesthesia depth monitor (麻醉深度监护仪), with its sedation depth index (NSI)","model_version":"Software release 1 (full version 1.0.0.143)","developer":"Sichuan Xinyuan Bioelectronics Technology Co., Ltd. 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The report says that the EEG detection algorithm is based on machine learning, but it does not say that this algorithm computes the sedation index."},"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：麻醉深度监护仪 (technical review report for the registration of an anesthesia depth monitor), acceptance no. CQZ2500601, applicant 四川新源生物电子科技有限公司. Undated report, posted on CMDE's website on 23 October 2026. 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：麻醉深度监护仪（CQZ2500601）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1792720030064015380.pdf","date":"2026-10-23","written_by":"independent","quote":"NSI 指数与 MOAA/S 评分一致率高于 BIS 值与 MOAA/S 评分一致率且差异有统计学意义"},{"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：麻醉深度监护仪 (technical review report for the registration of an anesthesia depth monitor), acceptance no. CQZ2500601, applicant 四川新源生物电子科技有限公司. Undated report, posted on CMDE's website on 23 October 2026. Section 三、临床评价概述 (clinical evaluation), CMDE's closing judgment on the clinical evidence. The report has no benefit-risk section.","title":"医疗器械产品注册技术审评报告：麻醉深度监护仪（CQZ2500601）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1792720030064015380.pdf","date":"2026-10-23","written_by":"independent","quote":"综上，申请人提供的临床评价资料符合目前的临床审评要求。"}],"replication":{"produced_by":["Six electrodes on the patient's forehead recorded EEG.","The monitor computed the sedation depth index (NSI) from quantitative EEG, with an EEG detection algorithm that the report says is based on machine learning.","Sedation was scored on the MOAA/S scale as the reference."],"must_hold":["The sedation depth index is meant for adult patients.","Anesthetic drugs change the frontal EEG in a measurable way, which the index tracks."],"echoes":[]},"paired_incident":null,"headline":"*BMP-10* sedation index tracked sedation scores better than BIS","metric":"agreed with sedation scores 90.62% of the time","comparator":{"against":"The BIS index, scored against the same MOAA/S sedation assessments in the trial","before":"Lower agreement of the BIS value with MOAA/S (figure not given)","after":"Higher agreement of the NSI with MOAA/S, a statistically significant difference","basis":"measured","quote":"NSI 指数与 MOAA/S 评分一致率高于 BIS 值与 MOAA/S 评分一致率且差异有统计学意义","url":"https://www.cmde.org.cn/directory/web/cmde/images/1792720030064015380.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The agreement 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/1792720030064015380.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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CQZ2500601, applicant 四川新源生物电子科技有限公司. Undated report, posted on CMDE's website on 23 October 2026. 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：麻醉深度监护仪（CQZ2500601）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1792720030064015380.pdf","date":"2026-10-23","written_by":"independent","quote":"NSI 指数与 MOAA/S 评分一致率高于 BIS 值与 MOAA/S 评分一致率且差异有统计学意义"},{"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：麻醉深度监护仪 (technical review report for the registration of an anesthesia depth monitor), acceptance no. CQZ2500601, applicant 四川新源生物电子科技有限公司. Undated report, posted on CMDE's website on 23 October 2026. Section 三、临床评价概述 (clinical evaluation), CMDE's closing judgment on the clinical evidence. 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It records EEG through six forehead electrodes and shows a sedation depth index, the NSI. The report says that the company submitted research on an EEG detection algorithm based on machine learning. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. For the NSI, the maker ran a prospective, multicenter, self-controlled trial with 140 patients at four clinical institutions. The reference standard was the MOAA/S sedation score. The NSI agreed with that score 90.62% of the time (95% CI 89.89% to 91.36%), which met the target. CMDE reports that the NSI agreed with MOAA/S more often than the BIS index did, a statistically significant difference. No patient had awareness during surgery, and no device-related adverse event occurred. CMDE concluded that “申请人提供的临床评价资料符合目前的临床审评要求” (the clinical evaluation data that the applicant provided meet current clinical review requirements). 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It records EEG through six forehead electrodes and shows a sedation depth index, the NSI. The report says that the company submitted research on an EEG detection algorithm based on machine learning. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. For the NSI, the maker ran a prospective, multicenter, self-controlled trial with 140 patients at four clinical institutions. The reference standard was the MOAA/S sedation score. The NSI agreed with that score 90.62% of the time (95% CI 89.89% to 91.36%), which met the target. CMDE reports that the NSI agreed with MOAA/S more often than the BIS index did, a statistically significant difference. No patient had awareness during surgery, and no device-related adverse event occurred. CMDE concluded that “申请人提供的临床评价资料符合目前的临床审评要求” (the clinical evaluation data that the applicant provided meet current clinical review requirements). 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