(127 days)
An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.
Not Found
The provided document describes an FDA 510(k) clearance for the Ellex Slit Lamp, Model 30XL, a medical device. This document is a regulatory approval letter, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for proving device performance in the context of an AI-powered diagnostic system.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a de novo clinical study proving performance against pre-defined acceptance criteria with the statistical rigor typically found in AI/ML device evaluations.
Therefore, I cannot provide the requested information from this document. If you have a different document describing a study for an AI-powered device, please provide that for analysis.
§ 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.