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A reading center graded separate images of the same eyes, taken by a professional photographer, as the reference standard. FDA reviewers report that the software found 173 of 198 people with the disease, an observed sensitivity of 87.4%, and that its observed specificity was 89.5%. It gave a usable result for 96.1% of participants with a reading center grade. FDA granted the De Novo request on 11 April 2018 and found that the probable benefits outweigh the probable risks. The trial measured accuracy against a reference standard. It did not measure vision outcomes, and 73 of the 892 participants who completed the procedures could not be fully analyzed.","category":"general benefit","unexpected":false,"purpose":"IDx-DR was built to detect more than mild diabetic retinopathy in primary care without a physician reading the images. 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