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K Number
K994340
Device Name
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
Manufacturer
HAI LABORATORIES, INC.
Date Cleared
2000-09-20

(272 days)

Product Code
HLI,NQE
Regulation Number
886.1570
Type
Abbreviated
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Clinical Specular Microscope Model HAI CL-1000xyz is intended to be used to examine the cornea of the eye.

Device Description

Clinical Specular Microscope, Model HAI CL-1000xyz

AI/ML Overview

The provided text is a 510(k) substantial equivalence letter and associated indications for use for the HAI Clinical Specular Microscope, Model HAI CL-1000xyz.

Unfortunately, this document does not contain the detailed information required to answer your request about acceptance criteria and the specific study proving the device meets those criteria.

Here's why and what's missing:

  • Nature of the document: A 510(k) clearance letter primarily states that a new device is substantially equivalent to a legally marketed predicate device. It signifies that the FDA has determined the device is as safe and effective as a previously cleared device. It generally does not include the detailed performance study data, acceptance criteria, or statistical analyses that would be found in a full submission.
  • Approval Date: The letter is dated April 26, 2004, which is before the widespread use and regulatory guidelines for AI/ML-driven devices. Specular microscopes primarily rely on optical principles, not AI, for their core function.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. It's highly unlikely for this type of device from 2004.
  6. If a standalone study was done: Not present in this document.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not present (and not applicable for a non-AI/ML device).
  9. How the ground truth for the training set was established: Not present (and not applicable).

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.