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510(k) Data Aggregation

    K Number
    K111771
    Device Name
    NON-CONTACT TEAR FILM THERMOGRAGH
    Manufacturer
    UNITED INTEGRATED SERVICES CO., LTD.
    Date Cleared
    2011-11-30

    (160 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UIS Non-Contact Thermograph System is an ophthalmic imaging device that stores, archives, and manipulates digital images of ocular surface temperature measurements taken by a physician in adult patients.

    Device Description

    The ocular surface temperature is measured by the thermal sensor of the thermograph system. The subject places his/her chin and forehead to the measuring bracket. Keep both eyes on the camera of the thermograph system. Listen to the voice instruction to close and open his/her eyes for recording the temperature variation of his/her ocular surface.

    AI/ML Overview

    The provided text is a 510(k) summary for the United Integrated Non-Contact Thermograph System Model IT-85. This document primarily focuses on establishing substantial equivalence to a predicate device (LipView Ocular Surface Interferometer K091935) and provides general information about the device and its intended use. It does not contain information about acceptance criteria, device performance studies, or details regarding test sets, ground truth establishment, or sample sizes for performance evaluation.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory filing for market clearance, not a performance study report.

    If you have a document that details the performance study for this device, please provide it, and I would be happy to analyze it for the information you've requested.

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