(276 days)
MYAH is intended to be used by an eye care professional:
- to measure the axial length of the eye in a population age 5 and above
- to capture and store digital images of the meibomian glands under near-infrared illumination in adult population.
MYAH is not intended to be used in patients with cataracts.
Not Found
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a device called "MYAH," which is an AC-Powered Slitlamp Biomicroscope. The letter states its indications for use (measuring axial length and capturing meibomian gland images) and mentions it's a Class II device.
However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific questions you've asked about device performance and validation.
Therefore, I cannot provide the requested information based on the text provided.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.