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510(k) Data Aggregation

    K Number
    K021720
    Device Name
    MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
    Manufacturer
    SOFLEX ISRALENS CONTACT LENS LTD.
    Date Cleared
    2002-08-12

    (80 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 0.75 diopters. The lens may be disinfected using a chemical disinfection system.

    Device Description

    MULTIVISION (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria, as requested.

    The document is a 510(k) clearance letter from the FDA for a contact lens. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance. However, it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Details about a specific study, including sample sizes, data provenance, number and qualifications of experts, or adjudication methods.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or how ground truth was established for training data.
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