AEYE-DS
AEYE Health Inc.The AEYE-DS device helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes by analyzing retinal images taken by specific fundus cameras. It uses AI technology to analyze the images and provides diagnostic screening results, improving early detection and management of diabetic eye disease.
Intended Use
The AEYE-DS is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy 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 camera and the Optomed Aurora camera.
Technology
AEYE-DS consists of five software components: Client (installed on a user computer connected to a fundus camera), Service, Analytics, Reporting & Archiving, and System Security modules. The Client guides image acquisition and sends fundus images via a secure internet connection to a server-based Analytics module that analyzes image quality and presence of mtmDR using AI algorithms. The results are returned to the Client.
Performance
Clinical performance was demonstrated in two prospective, multi-center, single-arm, blinded studies with diabetic adults, showing sensitivity 90-93%, specificity 89-94%, high imageability (99%), and high negative predictive values (~99%) for detection of more than mild diabetic retinopathy. The device also underwent software verification and validation, hazard analysis, cybersecurity assessment, and human factors validation with novice operators showing safe, efficient use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/8/2024
3 months - 2
FDA Approval
4/23/2024
Other devices from AEYE Health Inc.
- AEYE-DS2022 • 510K
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