AEYE-DS
AEYE Health, Inc.AEYE-DS is an AI-powered retinal diagnostic software that helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes using fundus images from a Topcon NW400 camera. It improves screening efficiency by analyzing images to identify disease presence, helping to guide timely patient care.
Intended Use
AEYE-DS device is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. The AEYE-DS is indicated for use with the Topcon NW400.
Technology
AEYE-DS is an AI software medical device comprising multiple software modules (Client, Service, Analytics, Reporting, Security) that analyzes fundus images acquired via a fundus camera attached to a computer. Images are transmitted securely to a server for AI-based analysis of image quality and detection of more-than-mild diabetic retinopathy, and results are returned to the user interface.
Performance
Performance was demonstrated in a multi-center clinical study with 531 diabetic adult subjects imaged with the Topcon NW400 fundus camera by novice operators. AEYE-DS achieved high sensitivity (~93-95%) and specificity (~88-91%) in detecting more-than-mild diabetic retinopathy, with high imageability (>99%) and reproducibility. Usability was confirmed via human factors testing. The device complies with IEC 62304, ISO 14971 standards and FDA software validation guidance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/25/2022
6 months - 2
FDA Approval
11/10/2022
Other devices from AEYE Health, Inc.
- AEYE-DS2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.