(232 days)
Specular Observation of the tear film
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This document is a 510(k) clearance letter from the FDA for the KEELER TEARSCOPE-PLUS. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the acceptance criteria, details of a study proving the device meets those criteria, or any information about AI/algorithm performance.
The 510(k) process primarily evaluates substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness information, often relying on comparisons to existing devices rather than new performance studies with pre-defined acceptance criteria in the way you've described.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.