{"id":"AIBD-1081","title":"China's CMDE finds that Airdoc-AIFUNDUS met its sensitivity and specificity targets for diabetic retinopathy in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, Airdoc-AIFUNDUS reached its preset sensitivity and specificity targets for diabetic retinopathy. The report gives no figures.","date_observed":"2020-07-31","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS, software that applies deep learning based on convolutional neural networks to fundus photographs of adults with diabetes. It advises doctors whether moderate non-proliferative diabetic retinopathy or worse is present and 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 as an innovative device. The trial was the maker's own, a prospective, multicenter, single-arm study with senior doctors' reading as the reference standard. The report says that sensitivity and specificity “达到预期目标值” (reached the preset targets) and that no adverse event occurred. It gives no figures and names neither the sites nor the number of patients. The report adds that “与预期受益相比较，综合剩余风险可接受” (compared with the expected benefit, the residual risk is acceptable). On 31 July 2020, CMDE recommended approval. It asked the company to study the accuracy of referrals further after approval, including use in primary care. The report does not say that the software's advice guided any patient's care.","category":"aggregate result","unexpected":false,"purpose":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS to advise practicing physicians whether fundus photographs of adults with diabetes show moderate non-proliferative diabetic retinopathy or worse and whether further examination is needed.","system":"Airdoc-AIFUNDUS (糖尿病视网膜病变眼底图像辅助诊断软件)","model_version":"Release V1.0 (full version V1.0.2020.04.02.01)","developer":"Shanghai Airdoc Medical Technology Co., Ltd. (上海鹰瞳医疗科技有限公司)","deployer":"Shanghai Airdoc Medical Technology (prospective multicenter registration trial)","location":"Trial sites in China that the report does not name","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The report gives no figures from the maker's pre-market trial and does not say that the software's advice guided care."}],"ai_role":{"status":"unassessed","statement":"The trial measured the software's sensitivity and specificity against senior doctors' reading and set them against preset targets. It did not compare diagnoses with and without the software. The trial was the maker's own. The report says that the software uses a deep learning algorithm based on convolutional neural networks."},"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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 三、临床评价摘要 (clinical evaluation summary).","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"糖尿病性视网膜病变的灵敏度与特异性结果达到预期目标值，在试验过程中未发生不良事件和严重不良事件"},{"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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 综合评价意见 (concluding evaluation), CMDE's own recommendation to approve, with a condition for further study after approval.","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"经系统评价后，建议准予注册。鉴于该产品远期安全性、有效性尚需进一步追踪，建议申请人在注册后进行以下工作：结合糖尿病视网膜病变分期、基层医疗卫生机构使用情况，对临床转诊的准确性进一步开展临床研究工作。"}],"replication":{"produced_by":["The software analyzed color fundus photographs of both eyes, centered on the optic disc and on the macula, taken without dilating the pupils.","An automatic quality check accepted the images before a deep learning module on a cloud server assessed them.","Senior doctors' reading served as the reference standard."],"must_hold":["Patients are adults with diabetes.","Images come from the specified fundus camera models and pass the automatic quality check.","Physicians make the diagnosis and do not base a clinical decision on the software's result alone."],"echoes":[]},"paired_incident":null,"headline":"*Airdoc-AIFUNDUS* met its retinopathy targets in China's review","metric":null,"comparator":{"against":"Preset targets for sensitivity and specificity, with senior doctors' reading as the reference standard","before":"Preset targets that the report does not state","after":"Sensitivity and specificity reached the targets","basis":"measured","quote":"糖尿病性视网膜病变的灵敏度与特异性结果达到预期目标值，在试验过程中未发生不良事件和严重不良事件","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.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 figures 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/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","case_jurisdictions":["China"],"profile":{"case_id":"AIBD-1081","catalog_version":"1.0.0","source_fingerprint":"424c78ce7b51445733ef341e560314fd795f93b6ee53a766c7b5631ae1d4e69d","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-1081-source-0001","AIBD-1081-source-0002"],"families":{"strategic assessments":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"evaluations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"monetary observations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"institutional decisions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]}},"fields":{"actors[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"developer":"Shanghai Airdoc Medical Technology Co., Ltd. (上海鹰瞳医疗科技有限公司)","deployer":"Shanghai Airdoc Medical Technology (prospective multicenter registration trial)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["developer","deployer"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"actors[].ownership_control":{"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"},"ai_contribution":{"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"},"ai_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"unassessed","statement":"The trial measured the software's sensitivity and specificity against senior doctors' reading and set them against preset targets. It did not compare diagnoses with and without the software. The trial was the maker's own. The report says that the software uses a deep learning algorithm based on convolutional neural networks."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role","category"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].alternatives":{"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"},"assessments[].assessor_date":{"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"},"assessments[].depth":{"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"},"assessments[].display_confidence":{"state":"value_present","value":{"kind":"structured","data":{"confidence":"high","evidence_word":"found","claim_status":"Found by a regulator","basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","interpretation":"Existing display rule preserved; the richer outcome-specific confidence question still needs review."}},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rationale":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The report gives no figures from the maker's pre-market trial and does not say that the software's advice guided care."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rubric_version":{"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"},"assessments[].status_basis":{"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"},"assessments[].target":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The report gives no figures from the maker's pre-market trial and does not say that the software's advice guided care."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"availability":{"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"},"brief":{"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"},"case_kind":{"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"},"case_links[]":{"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"},"claims[].evidence_links":{"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"},"claims[].evidence_strength":{"state":"value_present","value":{"kind":"structured","data":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","evidence_word":"found","claim_status":"Found by a regulator"}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-1081-source-0001","AIBD-1081-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report.","inferred":false}},"claims[].missingness":{"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"},"claims[].proposition":{"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"},"cross_border_flows[]":{"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"},"decisions[].action_outcome":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].grounds":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].institution_task":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].success_criterion":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"deployment_stage":{"state":"value_present","value":{"kind":"structured","data":{"classification":"pilot","answer":"The system was used in a pilot. The maker's prospective multicenter trial ran before approval, and the report does not say that the software's advice guided care.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-1081-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was used in a pilot. The maker's prospective multicenter trial ran before approval, and the report does not say that the software's advice guided care.","inferred":false}},"economics[].amount":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].costs[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].counterfactual":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].currency_price_basis":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].gross_net":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].measure_type":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].period_unit":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].realization":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].recipient_payer":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].return_payback":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].valuation_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"evaluations[].ai_uplift":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].comparator":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].design":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].effect":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].exposure":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].id":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].measurement_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].metric":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].reproduction_materials":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].setting_sample":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].uncertainty_limitations":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"external_references[]":{"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"},"follow_up[]":{"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"},"human_oversight":{"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"},"id":{"state":"value_present","value":{"kind":"record_fields","fields":{"id":"AIBD-1081"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["id"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"infrastructure_dependencies[]":{"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"},"outcomes[].beneficiaries":{"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"},"outcomes[].beneficiary_count":{"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"},"outcomes[].benefit_type":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS, software that applies deep learning based on convolutional neural networks to fundus photographs of adults with diabetes. It advises doctors whether moderate non-proliferative diabetic retinopathy or worse is present and 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 as an innovative device. The trial was the maker's own, a prospective, multicenter, single-arm study with senior doctors' reading as the reference standard. The report says that sensitivity and specificity “达到预期目标值” (reached the preset targets) and that no adverse event occurred. It gives no figures and names neither the sites nor the number of patients. The report adds that “与预期受益相比较，综合剩余风险可接受” (compared with the expected benefit, the residual risk is acceptable). On 31 July 2020, CMDE recommended approval. It asked the company to study the accuracy of referrals further after approval, including use in primary care. The report does not say that the software's advice guided any patient's care.","benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].distribution":{"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"},"outcomes[].duration":{"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"},"outcomes[].id":{"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"},"outcomes[].stakeholder_group":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The report gives no figures from the maker's pre-market trial and does not say that the software's advice guided care."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].status":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_status":"intended"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_status"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].tradeoffs":{"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"},"outcomes[].unexpected":{"state":"value_present","value":{"kind":"record_fields","fields":{"unexpected":false,"purpose":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS to advise practicing physicians whether fundus photographs of adults with diabetes show moderate non-proliferative diabetic retinopathy or worse and whether further examination is needed."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["unexpected","purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"places[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"location":"Trial sites in China that the report does not name","developer_country":"China","deployer_country":"China"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["location","developer_country","deployer_country"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"purpose":{"state":"value_present","value":{"kind":"record_fields","fields":{"purpose":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS to advise practicing physicians whether fundus photographs of adults with diabetes show moderate non-proliferative diabetic retinopathy or worse and whether further examination is needed."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"record_dates":{"state":"value_present","value":{"kind":"record_fields","fields":{"date_observed":"2020-07-31","date_basis":"source publication","date_precision":"day","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/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["date_observed","date_basis","date_precision","revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"replication.attempts[]":{"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"},"replication.conditions":{"state":"value_present","value":{"kind":"record_fields","fields":{"replication":{"produced_by":["The software analyzed color fundus photographs of both eyes, centered on the optic disc and on the macula, taken without dilating the pupils.","An automatic quality check accepted the images before a deep learning module on a cloud server assessed them.","Senior doctors' reading served as the reference standard."],"must_hold":["Patients are adults with diabetes.","Images come from the specified fundus camera models and pass the automatic quality check.","Physicians make the diagnosis and do not base a clinical decision on the software's result alone."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"revision_history[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"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/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sector":{"state":"value_present","value":{"kind":"record_fields","fields":{"domain":"Healthcare"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["domain"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].access_version":{"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[].citation_locator":{"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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 三、临床评价摘要 (clinical evaluation summary).","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"糖尿病性视网膜病变的灵敏度与特异性结果达到预期目标值，在试验过程中未发生不良事件和严重不良事件"},{"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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 综合评价意见 (concluding evaluation), CMDE's own recommendation to approve, with a condition for further study after approval.","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"经系统评价后，建议准予注册。鉴于该产品远期安全性、有效性尚需进一步追踪，建议申请人在注册后进行以下工作：结合糖尿病视网膜病变分期、基层医疗卫生机构使用情况，对临床转诊的准确性进一步开展临床研究工作。"}]}},"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-1081-source-0001","AIBD-1081-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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 三、临床评价摘要 (clinical evaluation summary).","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"糖尿病性视网膜病变的灵敏度与特异性结果达到预期目标值，在试验过程中未发生不良事件和严重不良事件"},{"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：糖尿病视网膜病变眼底图像辅助诊断软件 (technical review report for the registration of diabetic retinopathy fundus image diagnosis-aid software), acceptance no. CQZ1900653, applicant 上海鹰瞳医疗科技有限公司. 31 July 2020. Section 综合评价意见 (concluding evaluation), CMDE's own recommendation to approve, with a condition for further study after approval.","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900653）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjUzo6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"经系统评价后，建议准予注册。鉴于该产品远期安全性、有效性尚需进一步追踪，建议申请人在注册后进行以下工作：结合糖尿病视网膜病变分期、基层医疗卫生机构使用情况，对临床转诊的准确性进一步开展临床研究工作。"}]}},"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, Airdoc-AIFUNDUS reached its preset sensitivity and specificity targets for diabetic retinopathy. The report gives no figures.","account":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS, software that applies deep learning based on convolutional neural networks to fundus photographs of adults with diabetes. It advises doctors whether moderate non-proliferative diabetic retinopathy or worse is present and 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 as an innovative device. The trial was the maker's own, a prospective, multicenter, single-arm study with senior doctors' reading as the reference standard. The report says that sensitivity and specificity “达到预期目标值” (reached the preset targets) and that no adverse event occurred. It gives no figures and names neither the sites nor the number of patients. The report adds that “与预期受益相比较，综合剩余风险可接受” (compared with the expected benefit, the residual risk is acceptable). On 31 July 2020, CMDE recommended approval. It asked the company to study the accuracy of referrals further after approval, including use in primary care. The report does not say that the software's advice guided any patient's care."}},"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 V1.0 (full version V1.0.2020.04.02.01)"}},"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":"Airdoc-AIFUNDUS (糖尿病视网膜病变眼底图像辅助诊断软件)"}},"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 Airdoc-AIFUNDUS met its sensitivity and specificity targets for diabetic retinopathy in the maker's trial","headline":"*Airdoc-AIFUNDUS* met its retinopathy targets 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":["bf5cce6367beff4b5d78909ff22e3fdb659f72b32d82a3df14a6d22183237a6c"],"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":"Shanghai Airdoc Medical Technology built Airdoc-AIFUNDUS, software that applies deep learning based on convolutional neural networks to fundus photographs of adults with diabetes. It advises doctors whether moderate non-proliferative diabetic retinopathy or worse is present and 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 as an innovative device. The trial was the maker's own, a prospective, multicenter, single-arm study with senior doctors' reading as the reference standard. The report says that sensitivity and specificity “达到预期目标值” (reached the preset targets) and that no adverse event occurred. It gives no figures and names neither the sites nor the number of patients. The report adds that “与预期受益相比较，综合剩余风险可接受” (compared with the expected benefit, the residual risk is acceptable). On 31 July 2020, CMDE recommended approval. It asked the company to study the accuracy of referrals further after approval, including use in primary care. The report does not say that the software's advice guided any patient's care.","replication":{"produced_by":["The software analyzed color fundus photographs of both eyes, centered on the optic disc and on the macula, taken without dilating the pupils.","An automatic quality check accepted the images before a deep learning module on a cloud server assessed them.","Senior doctors' reading served as the reference standard."],"must_hold":["Patients are adults with diabetes.","Images come from the specified fundus camera models and pass the automatic quality check.","Physicians make the diagnosis and do not base a clinical decision 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":"8d3b56f1e86b73b18c20c035fca1b0601cbfc1aa7709f70bd62fb3732429ed62"}