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EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and visionthreatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diabetes who have not been previously diagnosed with diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 Plus AF, and Topcon NW400 caneras.

EyeArt is a software as a medical device that consists of three components - Client, Server, and Analysis Computation Engine. A retinal fundus camera, used to capture retinal fundus images of the patient, is connected to a computer where the EyeArt Client software is installed. The EyeArt Client software provides a graphical user interface (GUI) that allows the EyeArt operator to transfer the appropriate fundus images to and receive results from the remote EyeArt Analysis Computation Engine through the EyeArt Server. The EyeArt Analysis Computation Engine is installed on remote computer(s) in a secure data center and uses artificial intelligence algorithms to analyze the fundus images and return results. EyeArt is intended to be used with retinal fundus images of resolution 1.69 megapixels or higher captured using one of the indicated retinal fundus cameras (Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400) with 45 degrees field of view. EyeArt is specified for use with two retinal fundus images per eye: optic nerve head (ONH) centered and macula centered. For each patient eye, the EyeArt results separately indicate whether "more than mild diabetic retinopathy (mtmDR)" and "vision-threatening diabetic retinopathy (vtDR)" are detected.