EyeArt v2.2.0
Eyenuk, Inc.EyeArt v2.2.0 is an AI-based software device designed to automatically detect more than mild and vision-threatening diabetic retinopathy in retinal fundus images. It assists healthcare providers by analyzing images captured from specific retinal cameras and providing diagnostic screening results to help identify retinal disease in adults with diabetes, facilitating early detection and treatment.
Intended Use
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in eyes of adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. It is intended for use with Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400 cameras.
Technology
The device is software as a medical device consisting of three components: EyeArt Client (user interface on local computer connected to fundus camera), EyeArt Server (handles secure data transfer and storage), and EyeArt Analysis Computation Engine (remotely hosted AI algorithms analyzing retinal fundus images for diabetic retinopathy). The software uses artificial intelligence, including deep learning, analyzing optic nerve head and macula centered fundus images to classify diabetic retinopathy severity.
Performance
Non-clinical testing including extensive verification and validation confirmed correct functionality and risk mitigation with cybersecurity protections. Clinical testing included a multi-center prospective study (171 participants, 336 eyes) comparing EyeArt results to a clinical reference standard using the Early Treatment for Diabetic Retinopathy Study grading scale. The system showed high sensitivity (~95-97%) and specificity (~86-92%) for detection of more than mild and vision-threatening diabetic retinopathy. Additional retrospective study using data from 655 participants (1310 eyes) confirmed performance. Human factors testing confirmed usability of the device interface and workflow with indicated cameras.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/2/2022
7 months - 2
FDA Approval
6/16/2023
Other devices from Eyenuk, Inc.
- EyeArt2020 • 510K
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