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510(k) Data Aggregation

    K Number
    K972850
    Device Name
    SUNGLASSES
    Manufacturer
    INDOPTICA, S.A.
    Date Cleared
    1997-09-17

    (47 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

    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

    Device Description

    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for sunglasses (K972850). It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for AI/device performance evaluation.

    Therefore, I cannot provide the requested information based on the provided text. The letter is a regulatory approval, not a scientific study report.

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