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510(k) Data Aggregation

    K Number
    K972416
    Device Name
    MOMO DESIGN OR MOMO
    Manufacturer
    MOMO U.S.A., INC.
    Date Cleared
    1997-07-21

    (24 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

    The provided document is an FDA 510(k) clearance letter for "Momo Design Sunglasses" and an "Indications For Use" statement. It does not contain information regarding
    acceptance criteria, study details, device performance data, sample sizes, expert qualifications, or ground truth establishment for an AI/device study.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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