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510(k) Data Aggregation

    K Number
    K021295
    Device Name
    SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    ST. SHINE OPTICAL CO., LTD.
    Date Cleared
    2002-06-04

    (41 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily 'Vear is indicated for daily wear for correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 Diopters.

    Device Description

    Saview 55 Toric (methifilcon A) Soft (hydrophilic Contact Lens for Daily Wear

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a contact lens, which primarily states that the device is substantially equivalent to a predicate device.

    It does not include:

    • A table of acceptance criteria or reported device performance metrics.
    • Details about sample sizes, data provenance, or ground truth establishment for any studies.
    • Information on expert involvement, adjudication methods, or MRMC studies.
    • Information on standalone algorithm performance or training sets.

    Therefore, I cannot fulfill your request for this specific document.

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