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510(k) Data Aggregation

    K Number
    K203850
    Device Name
    CATS®-D Tonometer Prism
    Manufacturer
    CATS Tonometer LLC
    Date Cleared
    2021-06-14

    (165 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K173904
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.

    Device Description

    The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.

    AI/ML Overview

    This document does not contain information related to AI/ML device performance or clinical studies typical for AI/ML-based medical devices. The submission (K203850) is for a CATS®-D Tonometer Prism, which is a physical accessory for Goldmann type tonometers, not an AI/ML algorithm.

    The core of the submission focuses on demonstrating substantial equivalence to a predicate device (CATS® Reusable Tonometer prism K173904) through performance data related to:

    • Design verification: Ensuring the device meets its design specifications.
    • Sterilization validation and shelf-life testing: Confirming the sterility and stability of the disposable prism.
    • Biocompatibility testing: Cytotoxicity, sensitization, and irritation tests according to ISO 10993 standards.

    There is no mention of:

    • Acceptance criteria for an algorithm's performance (e.g., accuracy, sensitivity, specificity).
    • A test set with ground truth or expert annotations.
    • Sample sizes for AI/ML model testing or training.
    • The number or qualifications of experts.
    • MRMC studies or human reader improvement with AI assistance.
    • Standalone algorithm performance.

    Therefore, I cannot provide a response to the prompt's specific requirements, as they are geared towards AI/ML device evaluations, which are not relevant to this 510(k) submission.

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