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K Number
K981432
Device Name
GOLDMAN MANUAL TONOMETER
Manufacturer
GOLDEN VISION, INC.
Date Cleared
1999-01-12

(267 days)

Product Code
HKY
Regulation Number
886.1930
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRACCULARY RESURE, NOORDING TO MEINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA. IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) substantial equivalence determination letter from the FDA for a medical device called the "Haag-Streit Goldmann Manual Tonometer." This type of letter generally does not contain the detailed acceptance criteria and study results you are asking for.

Here's why and what information can be gleaned:

  • 510(k) Process: A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparisons of design, materials, indications for use, and performance data (often bench testing) to show that the new device is as safe and effective as the predicate. It does not usually involve extensive clinical trials with the kind of detailed statistical analysis, ground truth establishment, and expert adjudication you describe for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, I cannot provide a response filling in all categories of your request based on the provided text. However, I can extract the relevant information and explain what is missing:

Information from the document:

  • Device Name: Haag-Streit Goldmann Manual Tonometer (also referred to as "GOLDMAN MANUAL TONOMETER")
  • Indications for Use: "THE GOLDMAN MANUAL TONOMETER IS AN APPLIANCE THAT SERVES TO MEASURE INTRAOCULAR PRESSURE, ACCORDING TO THE GOLDMAN METHOD. IT IS USED TO MEASURE INTRAOCULAR PRESSURE AND TO MAINTAIN A UNIFORM APPLANATION OF THE SURFACE OF THE CORNEA. IT IS SPECIALLY INDICATED IN GLAUCOMA DISEASE."
  • Regulation Number/Name: 886.1930 / Tonometer and accessories
  • Regulatory Class: Class II
  • Product Code: HKY
  • Type of Submission: 510(k) Premarket Notification (K981432)

Detailed Breakdown of Missing Information (and why it's missing in a 510(k) for this type of device):

  1. A table of acceptance criteria and the reported device performance

    • Missing: The document does not specify quantitative acceptance criteria or detailed performance metrics. For a manual tonometer, performance is typically assessed through manufacturing specifications (e.g., accuracy, precision) that would be compared to a predicate device, but these are not disclosed in this summary letter.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Missing: This information is not typically part of a 510(k) determination letter for a physical medical device like a tonometer. If any performance testing was done, it would likely be laboratory or bench testing, not a "test set" in the sense of clinical data.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Missing: This concept of "ground truth" and expert adjudication is more pertinent to diagnostic AI/SaMD devices. For a manual tonometer, the "ground truth" is typically a known physical pressure or a reference standard device.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Missing: Not applicable for a manual tonometer's 510(k).

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Missing: Not applicable. This device is a manual tonometer, not an AI or software-assisted device.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Missing: Not applicable. This device is a manual tonometer, not a standalone algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Missing: For a tonometer, the "ground truth" would relate to the accuracy of intraocular pressure measurement against a known standard. The document does not specify how this was established or measured.

  8. The sample size for the training set

    • Missing: Not applicable. This is not an AI/machine learning device that requires a training set.

  9. How the ground truth for the training set was established

    • Missing: Not applicable. This is not an AI/machine learning device.

In summary: The provided document is an FDA 510(k) clearance letter for a manual tonometer, a physical medical device. The type of detailed study information requested (especially regarding AI/ML, ground truth, experts, and adjudication) is not applicable to this device or typically found in such a clearance letter. This information would be required for a Software as a Medical Device (SaMD) or AI-powered device, which this is not.

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.