IDx-DR v2.3
Digital Diagnostics Inc.IDx-DR v2.3 is an AI-based diagnostic software that automatically detects more than mild diabetic retinopathy from retinal images captured with a Topcon NW400 fundus camera. It helps healthcare providers identify patients who need referral to eye care professionals, improving timely diagnosis and management of diabetic retinopathy.
Intended Use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy (mtmDR) 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
IDx-DR v2.3 consists of AI software components including IDx-DR Analysis (image processing and classification), IDx-DR Client (user interface and image transfer software), and IDx-DR Service (secure server hosting and cybersecurity). It analyzes fundus images from a Topcon NW400 camera, providing automated diabetic retinopathy diagnosis without other patient data.
Performance
Performance testing including retrospective clinical validation of AI algorithm upgrades demonstrates maintained sensitivity (~88%) and specificity (~90%) in detecting more than mild diabetic retinopathy, with diagnosability over 95% after final image acquisition protocols, supporting substantial equivalence with the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/21/2021
8 months - 2
FDA Approval
6/17/2022
Other devices from Digital Diagnostics Inc.
- IDx-DR2021 • 510K
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