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Verily Numetric Retinal Camera
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
The Verily Numetric Retinal Camera has the following acceptance criteria and reported device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resolving power (center) | ≥ 60 line pairs/mm at the center of the field | Pass |
| Resolving power (mid field) | ≥ 40 line pairs/mm at the mid field (r/2) | Pass |
| Resolving power (periphery) | ≥ 25 line pairs/mm at the periphery of the field (r) | Pass |
| Field of view | 45 degrees | Pass |
| Pixel pitch tolerance |
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