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    K Number
    K173904
    Device Name
    CATS Tonometer Prism
    Manufacturer
    CATS Tonometer, LLC
    Date Cleared
    2018-03-09

    (77 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K981432
    Why did this record match?
    Device Name :

    CATS Tonometer Prism

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.

    Device Description

    The CATS Tonometer™ Prism is used as an optical image prism for Goldmann applanation style tonometers. It is a modification of the standard Goldmann Applanation Tonometer (GAT) prism, with the only alteration being the modification of the flat surface in the GAT to a curved surface and a compensatory lengthening in the CATS prism. The CATS prism is made of PMMA, the corneal contact diameter is 7 mm and the total length of the prism is 30 mm.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the CATS Tonometer™ Prism:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Success Criteria for Primary Endpoint)Reported Device Performance
    CATS tonometer prism measurements to be within ± 5 mmHg of the GAT tonometer prism measurements."No statistically significant difference in IOP measurement was observed between the CATS tonometer prism and the reference GAT tonometer prism."
    No more than 5% of the paired differences between the reference tonometer (CATS prism) and the test tonometer (GAT prism) readings for each pressure range, would be greater than the tolerance levels:
    • 7 to 16 mmHg: ±5

    • 16 to

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