目的：评估白内障人工智能辅助诊断系统在社区筛查中的应用效果。方法：采用前瞻性观察性研究方法对白内障人工辅助诊断系统的应用效果进行分析，结合远程医疗的模式，由社区卫生人员对居民进行病史采集、视力检查和裂隙灯眼前节检查等，将数据上传至云平台，由白内障人工智能辅助诊断系统和人类医生依次进行白内障评估。结果：受检人群中男性所占比例为35.7%，年龄中位数为66岁，裂隙灯眼前节照片有98.7%的图像质量合格。该白内障人工智能辅助诊断系统在外部验证集中检出重度白内障的曲线下面积为0.915。在人类医生建议转诊的病例中，有80.3%也由人工智能系统给出了相同的建议。结论：该白内障人工智能辅助诊断系统在白内障社区筛查的应用中具有较好的可行性和准确性，为开展社区筛查疾病提供了参考依据。
Objective: To evaluate the effectiveness of an artificial intelligence-assisted diagnostic system for cataract screening in community. Methods: A prospective observational study was carried out based on a telemedicine platform. Patient history, medical records and anterior ocular segment images were collected and transmitted from community healthcare centers to Zhongshan Ophthalmic Center for evaluation by both ophthalmologists and artificial intelligence-assisted cataract diagnostic system. Results: Of all enumerated subjects, 35.7% were male and the median age was 66 years old. Of all enumerated slit-lamp images, 98.7% met the requirement of acceptable quality. This artificial intelligence-assisted diagnostic system achieved an AUC of 0.915 for detection of severe cataracts in the external validation dataset. For subjects who were advised to be referred to tertiary hospitals by doctors, 80.3% of them received the same suggestion from this artificial intelligence-assisted diagnostic system.Conclusion: This artificial intelligence-assisted cataract diagnostic system showed high applicability and accuracy in community-based cataract screening and could be a potential model of care in community-based disease screening.
本文根据上海鹰瞳医疗科技有限公司的创新产品《糖尿病视网膜病变眼底图像辅助诊断软件》在国家药品监督管理局(NMPA，原CFDA)历时两年半的上市前创新申报与注册申报经历，介绍了人工智能类医疗器械产品的产品研发、注册申报流程及相关重点难点，并且列明了在整个过程中需要遵循和参考的法律法规，为此类产品的上市前注册工作提供参考。
Based on the NMPA premarket application through two and a half years for the computer aided diagnosis software using fundus images of diabetic retinopathy, which is an innovative medical device of Shanghai EagleVision Medical Technology Co., Ltd. (Airdoc), this article introduced the development process, the premarket application, and the key points in the application of this artificial intelligence device, also lists the related regulations and guidelines as references to provide some ideas for the follow-up premarketing application of such kind of products.
眶尖部肿瘤为眼科罕见疾病，但因其所处位置特殊，对机体，特别是视神经功能危害极大，错误的诊断、不规范合理的治疗不仅不能解决问题，甚至会对机体造成严重的不可挽回的损害。目前针对眶尖部肿瘤的诊断、治疗多建立在医生的主观认知与经验的基础上，尚未达成共识。本文通过分析眶尖部肿瘤的临床特点，结合以往漏诊、误诊、误治的临床案例，阐述眶尖肿瘤正确诊断的关键要点；同时，结合不同临床案例，客观分析治疗方案，尤其是手术方式、路径，为眶尖部肿瘤的合理化治疗提供依据，以期规范眶尖部肿瘤的诊断和治疗，提高治疗成功率。
Although orbital apical tumor is a rare ophthalmic disease, its special location can cause great harm to the body, especially to the function of the optic nerve. Misdiagnosis and improper treatment are not only unable to solve the problem, but also irretrievably harmful to the body. At present, there is no consensus on the diagnosis and treatment of orbital apical tumors, which are mostly based on subjective cognition and experience of doctors. In this paper, the clinical characters of orbital apical tumors were analyzed through the past clinical cases of misdiagnosis and mistreatment, and the key points of proper diagnosis of orbital apical tumors were expounded. Meanwhile, by combining with different clinical cases, the treatment plans, especially the surgical approaches, were analysed to provide a basis for the appropriate treatment of orbital apical tumors, in order to standardize the diagnosis and treatment of orbital apex tumor, and improve the success rate of treatment.
