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510(k) Data Aggregation

    K Number
    K971495
    Device Name
    PATHFINDER SUNGLASSES
    Manufacturer
    COIL
    Date Cleared
    1997-05-29

    (35 days)

    Product Code
    HQY
    Regulation Number
    886.5850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The COIL Pathfinder Sunglasses are intended to be worn by a person to protect the eyes from bright sunlight, but do not provide for refractive correction.

    Device Description

    Sunglasses, Nonprescription, Class I 886.5850, 86HQY

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.

    The document is an FDA 510(k) clearance letter for "Pathfinder Sunglasses." It states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device and does not require a new Pre-Market Approval (PMA) application.

    A 510(k) clearance typically relies on demonstrating substantial equivalence, often through comparisons to predicate devices and adherence to relevant performance standards, rather than requiring extensive clinical trials with detailed acceptance criteria and performance reports like those detailed in your request.

    Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on this document.

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