Validation of the Eyerobo FC Portable Fundus Camera for Diabetic Retinopathy Screening Using Public Datasets and Deep Learning.

INTRODUCTION: To validate the diagnostic performance of the Eyerobo FC, a new portable non-mydriatic fundus camera for diabetic retinopathy (DR) screening, against an established desktop fundus camera benchmark using a transfer-learning approach in which artificial intelligence (AI)-based detection algorithms trained on desktop images were applied to Eyerobo FC images. METHODS: This prospective validation study employed a three-tier experimental design. Tier 1 involved training a deep learning model (EfficientNet-B4) on standard desktop camera images from EyePACS and APTOS 2019 datasets. Tier 2 established the reference standard by evaluating the trained model on the Messidor-2 dataset (N = 1748 eyes) captured with a Topcon TRC NW6 desktop camera (sensitivity 92.7%, 95% CI 91.2-94.2%; AUC 0.952, 95% CI 0.943-0.961). Tier 3 validated the same AI model (without retraining) on images from the Eyerobo FC in a prospective cohort (N = 104 eyes: 52 referable DR, 52 non-referable). The primary outcome was noninferiority of sensitivity and specificity (margin Δ = 10%) compared with the desktop benchmark. Statistical analysis included bootstrap resampling (1000 iterations) for confidence intervals and a one-sided Z-test for the difference of proportions to assess noninferiority. RESULTS: In a balanced cohort of 104 eyes (52 referable DR, 52 non-referable), the Eyerobo FC achieved sensitivity of 92.3% (95% CI 84.4-98.2%) and specificity of 94.2% (95% CI 87.0-100%), demonstrating noninferior performance compared with the desktop benchmark (sensitivity 92.7%, specificity 94.3%). The sensitivity difference of - 0.4 percentage points and the specificity difference of - 0.1 percentage points were both within the noninferiority margin. AUC was 0.977 (95% CI 0.945-0.997) versus 0.952 for the desktop benchmark. The AI model correctly classified 97 of 104 eyes (93.3% accuracy, 95% CI 88.5-98.1%), with 4 false negatives and 3 false positives. Noninferiority was statistically confirmed for both sensitivity and specificity (P < 0.05). Inter-grader agreement was excellent (Cohen's kappa = 0.917). Nonmydriatic image gradability rate was 94.4%. Grad-CAM visualization confirmed appropriate model attention to hemorrhages, exudates, and microaneurysms rather than artifacts. CONCLUSIONS: The Eyerobo fundus camera demonstrates noninferior diagnostic performance (sensitivity 92.3%, specificity 94.2%, AUC 0.977) compared with desktop systems when evaluated with AI algorithms trained exclusively on desktop images. These findings support deploying portable AI-assisted screening in resource-constrained and point-of-care settings, with successful cross-domain transfer learning enabling algorithmic generalizability across imaging platforms.