(78 days)
An AC-powered slitlamp biomicroscope is intended . for use in eye examination of the anterior eye 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
Biomicroscope, Slit Lamp AC Powered
While the provided document is an FDA 510(k) clearance letter for a "Slit Lamp" (Biomicroscope), it does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) clearance process primarily determines substantial equivalence to a predicate device, not necessarily in-depth performance studies against specific clinical acceptance criteria for an AI or advanced medical device. Given the date of the document (1999), it predates the widespread use of AI in medical devices and the level of detail regarding performance studies typically required for AI-powered devices today.
Therefore, I cannot fulfill your request with the provided input. The document
- Does not mention AI assistance.
- Does not provide a table of acceptance criteria or reported device performance.
- Does not detail sample size for test sets, data provenance, expert qualifications, or adjudication methods.
- Does not describe MRMC studies or standalone algorithm performance.
- Does not specify the type of ground truth used or details about training sets.
§ 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.