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K Number
K063750
Device Name
XCEL 255 SLIT LAMP
Manufacturer
REICHERT INC.
Date Cleared
2006-12-20

(1 days)

Product Code
HJO
Regulation Number
886.1850
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

An AC-Powered 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.

Device Description

Not Found

AI/ML Overview

The document provided is a 510(k) clearance letter from the FDA for a device called "Xcel 255 Slit Lamp". This type of document confirms that a new medical device is substantially equivalent to a legally marketed predicate device, rather than providing a detailed technical study or specific performance metrics.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Information on standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document serves as a regulatory clearance, indicating equivalence to an existing device, but does not detail the technical performance testing that would typically be described in a study report.

§ 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.