(15 days)
AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens.
Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.
Binocular Indirect ophthalmoscope: AAIO-7 AAIO WIRELESS
I am sorry, but the provided documentation does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The text primarily consists of an FDA clearance letter for a device and its indications for use. There is no mention of:
- Acceptance criteria tables or reported device performance
- Details of a study, including sample sizes, data provenance, ground truth establishment, or expert qualifications
- Adjudication methods
- MRMC studies or effect sizes
- Standalone algorithm performance
- Training set details
Therefore, I cannot fulfill your request based on the given input.
§ 886.1570 Ophthalmoscope.
(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.