LogoFDA 510(k) Search
K Number
K970414
Device Name
CONFOCAL MICROSCOPE
Manufacturer
CON-S LTD.
Date Cleared
1997-07-15

(173 days)

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

Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.

Device Description

CON-S LTD. CONFOCAL MICROSCOPE

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Confocal Microscope, and as such, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that would typically be found in a study report. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information, which includes:

  1. A table of acceptance criteria and the reported device performance: This document does not specify any performance attributes or acceptance criteria for the device, nor does it report any specific performance data.
  2. Sample size used for the test set and the data provenance: Not available in this clearance letter.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this clearance letter.
  4. Adjudication method for the test set: Not available in this clearance letter.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available in this clearance letter.
  6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (confocal microscope), not an AI algorithm.
  7. The type of ground truth used: Not available in this clearance letter.
  8. The sample size for the training set: Not applicable, as this is a physical medical device (confocal microscope), not an AI algorithm requiring a training set.
  9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The document states that the device has "the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope," which are "to view ocular images, and evaluate ocular disease and infections in patients." The substantial equivalence determination means that the FDA believes the new device performs as safely and effectively as a legally marketed predicate device, but it does not detail the specific studies or performance data that led to this conclusion.

§ 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.