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510(k) Data Aggregation

    K Number
    K000233
    Device Name
    MENICON SF-P
    Manufacturer
    MENICON CO. LTD.
    Date Cleared
    2000-05-19

    (113 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MENICON SF-P

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K972443
    Device Name
    MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    MENICON U.S.A., INC.
    Date Cleared
    1997-08-22

    (53 days)

    Product Code
    HQD
    Regulation Number
    886.5916
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS

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

    The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

    The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

    Device Description

    The Menicon SF-P (melafocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate, siloxanylmethacrylate and methacrylic acid with water absorbance of less than 0.5% by weight. The lens is available in blue tint. The blue tinted lens contains D&C Green No. 6 as the color additive.

    The Menicon Z (tisilfocon A) RGP lens is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. Lens colors available are light blue and violet. The blue lens is tinted with color additive D & C Green No. 6 and the violet lens contains the color additives D & C Green No. 6 and D & C Violet No. 2. Also, UV absorber is added.

    Solution used for packaging the Menicon RGP lenses:

    BARNES-HIND® ComfortCare® GP WETTING & SOAKING SOLUTION, which contains edetate disodium and chlorhexidine gluconate as preservatives.

    AI/ML Overview

    The provided document is a 510(k) summary for Menicon Rigid Gas Permeable Contact Lenses and discusses their substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

    This document describes a process change for contact lenses (wet storage vs. dry storage) and focuses on non-clinical stability, microbiology, and toxicology testing to support substantial equivalence. It does not involve a study with a test set, ground truth established by experts, or any performance evaluation against numerical acceptance criteria for a diagnostic or AI-driven device.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details on sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.

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