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The consensus of three senior chest radiologists served as the reference standard. The report says that doctors' sensitivity for nodules and for patients met clinical needs with the software and that their specificity did not fall. It gives no figures, and it reports no result for reading time, a secondary endpoint. CMDE judged that the product “在临床性能满足临床使用需求的基础上，提高阅片效率” (improves reading efficiency, provided that its clinical performance meets clinical needs). On 23 November 2020, it found that the benefits outweigh the risks and recommended registration. 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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：肺结节CT影像辅助检测软件（CQZ2000139）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743643287649029450.pdf","date":"2020-11-23","written_by":"independent","quote":"该产品临床主要受益为：辅助影像科医生进行 CT 影像阅片，在临床性能满足临床使用需求的基础上，提高阅片效率。"}],"replication":{"produced_by":["The software detected lung nodules on chest CT images in DICOM 3.0 format with deep learning.","Doctors read cases with and without the software in a randomized crossover design.","The consensus of three senior chest radiologists served as the reference standard."],"must_hold":["Nodules are 4 mm or larger.","Senior doctors review the reports, and no clinical decision rests on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*MIDS-PNAS* aided lung nodule detection on CT in China's review","metric":null,"comparator":{"against":"The same doctors reading without the software, in a randomized crossover design with three senior chest radiologists' consensus as the reference","before":"Doctors reading without the software (no figures given)","after":"Sensitivity met clinical needs, and patient-level specificity did not fall (no figures given)","basis":"measured","quote":"本软件在辅助医生进行肺结节检测时，医生肺结节检出灵敏度（以结节为单位）和患者肺结节检出灵敏度（以患者为单位）满足临床使用需求，同时医生在使用软件进行肺结节检测时也没有降低医生患者检出肺结节特异度（以患者为单位）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743643287649029450.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The report gives no figures from the maker's pre-market trial 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/1743643287649029450.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：肺结节CT影像辅助检测软件（CQZ2000139）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743643287649029450.pdf","date":"2020-11-23","written_by":"independent","quote":"该产品临床主要受益为：辅助影像科医生进行 CT 影像阅片，在临床性能满足临床使用需求的基础上，提高阅片效率。"}]}},"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 randomized crossover trial that China's CMDE reviewed, doctors using MIDS-PNAS met clinical needs for lung nodule sensitivity without losing specificity. No figures are given.","account":"Deepwise built MIDS-PNAS, software that uses deep learning to detect lung nodules of 4 mm or more on chest CT and analyze their features. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as an innovative device. The trial was the maker's. It was prospective and randomized, and doctors read cases with and without the software in a crossover design. The consensus of three senior chest radiologists served as the reference standard. The report says that doctors' sensitivity for nodules and for patients met clinical needs with the software and that their specificity did not fall. It gives no figures, and it reports no result for reading time, a secondary endpoint. CMDE judged that the product “在临床性能满足临床使用需求的基础上，提高阅片效率” (improves reading efficiency, provided that its clinical performance meets clinical needs). On 23 November 2020, it found that the benefits outweigh the risks and recommended registration. It asked the maker to keep studying how the algorithm generalizes and to review clinical use every year for its next registration."}},"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 1 (full version 1.2.0.1)"}},"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":"MIDS-PNAS (肺结节CT影像辅助检测软件)"}},"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 doctors using MIDS-PNAS met clinical needs in the maker's trial and judges that it makes lung CT reading more efficient","headline":"*MIDS-PNAS* aided lung nodule detection on CT 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":["9a8833faf81102d2afe5df29b2c55fd2c6c26f7e0452019d6e51637f3d2bc1ad"],"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":"Deepwise built MIDS-PNAS, software that uses deep learning to detect lung nodules of 4 mm or more on chest CT and analyze their features. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration as an innovative device. The trial was the maker's. It was prospective and randomized, and doctors read cases with and without the software in a crossover design. The consensus of three senior chest radiologists served as the reference standard. The report says that doctors' sensitivity for nodules and for patients met clinical needs with the software and that their specificity did not fall. It gives no figures, and it reports no result for reading time, a secondary endpoint. CMDE judged that the product “在临床性能满足临床使用需求的基础上，提高阅片效率” (improves reading efficiency, provided that its clinical performance meets clinical needs). On 23 November 2020, it found that the benefits outweigh the risks and recommended registration. It asked the maker to keep studying how the algorithm generalizes and to review clinical use every year for its next registration.","replication":{"produced_by":["The software detected lung nodules on chest CT images in DICOM 3.0 format with deep learning.","Doctors read cases with and without the software in a randomized crossover design.","The consensus of three senior chest radiologists served as the reference standard."],"must_hold":["Nodules are 4 mm or larger.","Senior doctors review the reports, and no clinical decision rests 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":"1341206fa3fda271988f134bb77c380f75582cfb2f4349914f261a5c6dec5db8"}