IDx-DR
Digital Diagnostics Inc.IDx-DR is an AI software device designed to help healthcare providers automatically detect more than mild diabetic retinopathy in diabetic adult patients using retinal fundus images. It assists clinicians by analyzing images captured from a specialized retinal camera and providing a diagnostic screening result, thus potentially improving early detection and management of diabetic eye disease.
Intended Use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. It is indicated for use with the Topcon NW400 fundus camera.
Technology
The device uses AI software to analyze two fundus images per eye obtained via a Topcon NW400 fundus camera. It comprises a client software running on local computers to acquire and send images securely over a network to a cloud-based analysis service that evaluates image quality and presence of diabetic retinopathy, and returns results to the user interface. Key components include IDx-DR Client, IDx-Service, and IDx-DR Analysis software, hosted on secure servers.
Performance
The device underwent comprehensive software validation including risk analysis, cybersecurity assessment, and usability testing. The usability study showed that untrained operators could successfully capture sufficient quality images according to protocol using the indicated camera and training materials. Clinical performance was deemed equivalent to the predicate device, with no new clinical data submitted but reference made to prior pivotal clinical trial data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2020
6 months - 2
FDA Approval
6/10/2021
Other devices from Digital Diagnostics Inc.
- IDx-DR v2.32022 • 510K
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