Abstract
PURPOSE: This study aimed to determine the generalizability of an artificial intelligence (AI) algorithm trained on an ethnically diverse dataset to screen for referable diabetic retinopathy (RDR) in the Armenian population unseen during AI development. METHODS: This study comprised 550 patients with diabetes mellitus visiting the polyclinics of Armenia over 10 months requiring diabetic retinopathy (DR) screening. The Medios AI-DR algorithm was developed using a robust, diverse, ethnically balanced dataset with no inherent bias and deployed offline on a smartphone-based fundus camera. The algorithm here analyzed the retinal images captured using the target device for the presence of RDR (i.e., moderate non-proliferative diabetic retinopathy (NPDR) and/or clinically significant diabetic macular edema (CSDME) or more severe disease) and sight-threatening DR (STDR, i.e., severe NPDR and/or CSDME or more severe disease). The results compared the AI output to a consensus or majority image grading of three expert graders according to the International Clinical Diabetic Retinopathy severity scale. RESULTS: On 478 subjects included in the analysis, the algorithm achieved a high classification sensitivity of 95.30% (95% CI: 91.9%-98.7%) and a specificity of 83.89% (95% CI: 79.9%-87.9%) for the detection of RDR. The sensitivity for STDR detection was 100%. CONCLUSION: The study proved that Medios AI-DR algorithm yields good accuracy in screening for RDR in the Armenian population. In our literature search, this is the only smartphone-based, offline AI model validated in different populations.