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510(k) Data Aggregation

    K Number
    K973490
    Device Name
    SUNGLASSES
    Date Cleared
    1997-09-30

    (15 days)

    Product Code
    Regulation Number
    886.5850
    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

    I am sorry, but the provided text is a 510(k) clearance letter for "Sunglasses" and an "Indications For Use" statement. It explicitly states that the device is "intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections."

    This document does not contain information about:

    • Acceptance criteria and reported device performance (beyond its intended use as sunglasses).
    • Details of any study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested table or answer the questions based on the input. The document is primarily about regulatory clearance for a non-medical, over-the-counter item, not a device with complex performance metrics requiring such detailed study information.

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