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Intended Use

EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy (including severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, and diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy. It is for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras in primary care and eye care settings.

Technology

EyeArt consists of three software components: a local Client for image handling, a Server for secure data transmission and storage, and a remote Analysis Computation Engine located in a secure data center that uses AI (deep learning) algorithms to analyze color fundus images of the retina and provide detection results of diabetic retinopathy severity.

Performance

The safety and effectiveness of EyeArt were demonstrated in a prospective, multicenter, pivotal clinical trial involving 655 adults with diabetes, comparing AI results with expert reference grading of dilated fundus photography. Sensitivity for detecting more than mild diabetic retinopathy was 92.9% to 100% and specificity ranged from 85.2% to 92.2% depending on cohort. The device showed high imageability (>96%) and repeatability/reproducibility, with results supporting substantial equivalence to a legally marketed predicate device.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/13/2020

    4 months
  • 2

    FDA Approval

    8/3/2020

Other devices from Eyenuk, Inc

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