The Validation of Deep Learning-Based Grading Model for Diabetic Retinopathy

PURPOSE: To evaluate the performance of a deep learning (DL)-based artificial intelligence (AI) hierarchical diagnosis software, EyeWisdom V1 for diabetic retinopathy (DR). MATERIALS AND METHODS: The prospective study was a multicenter, double-blind, and self-controlled clinical trial. Non-dilated posterior pole fundus images were evaluated by ophthalmologists and EyeWisdom V1, respectively. The diagnosis of manual grading was considered as the gold standard. Primary evaluation index (sensitivity and specificity) and secondary evaluation index like positive predictive values (PPV), negative predictive values (NPV), etc., were calculated to evaluate the performance of EyeWisdom V1. RESULTS: A total of 1,089 fundus images from 630 patients were included, with a mean age of (56.52 ± 11.13) years. For any DR, the sensitivity, specificity, PPV, and NPV were 98.23% (95% CI 96.93–99.08%), 74.45% (95% CI 69.95-78.60%), 86.38% (95% CI 83.76-88.72%), and 96.23% (95% CI 93.50-98.04%), respectively; For sight-threatening DR (STDR, severe non-proliferative DR or worse), the above indicators were 80.47% (95% CI 75.07-85.14%), 97.96% (95% CI 96.75-98.81%), 92.38% (95% CI 88.07-95.50%), and 94.23% (95% CI 92.46-95.68%); For referral DR (moderate non-proliferative DR or worse), the sensitivity and specificity were 92.96% (95% CI 90.66-94.84%) and 93.32% (95% CI 90.65-95.42%), with the PPV of 94.93% (95% CI 92.89-96.53%) and the NPV of 90.78% (95% CI 87.81-93.22%). The kappa score of EyeWisdom V1 was 0.860 (0.827-0.890) with the AUC of 0.958 for referral DR. CONCLUSION: The EyeWisdom V1 could provide reliable DR grading and referral recommendation based on the fundus images of diabetics.