(13 days)
A slitlamp biomicroscope is intended for use in eye examination of - the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "PSL Portable Slit Lamp". It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The letter is a regulatory document confirming clearance, not a technical report detailing performance study results.
Therefore, I cannot provide the requested information from this document.
§ 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.