LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022128
    Device Name
    BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Date Cleared
    2002-08-22

    (52 days)

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

    BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

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

    The BOSTON® EQUALENS® II (oprifocon A) RGP contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes.

    The lens may be disinfected using a chemical disinfection system only.

    Device Description

    The BOSTON® EQUALENS® II (oprifocon A) is a Rigid Gas Permeable Contact Lens material composed of methyl methacrylate fluoroitaconate siloxanyl copolymer with an ultraviolet absorber.

    The color additives conform to 21 CFR Part 74. The lens may also be supplied clear (no tint).

    The physical / optical properties of the lens are:

    Property: Specific Gravity, BOSTON EQUALENS II: 1.24
    Property: Refractive Index, BOSTON EQUALENS II: 1.423
    Property: Light Absorbance (Absorbance Units/Inch), BOSTON EQUALENS II: 9.4 Blue, 4.8 Green
    Property: Water Content, BOSTON EQUALENS II:

    AI/ML Overview

    The provided text describes a 510(k) summary for the BOSTON® EQUALENS® II (oprifocon A) Rigid Gas Permeable Contact Lenses. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance evaluation.

    Instead, this document is a regulatory submission for a medical device (contact lenses) based on substantial equivalence to a predicate device. This means the manufacturer is asserting that their new contact lens is as safe and effective as a previously approved contact lens, based on its physical/optical properties and intended use.

    Therefore, I cannot fulfill your request for information related to acceptance criteria, device performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text, which pertains to a traditional medical device approval process, not an AI/ML device evaluation.

    The text does give information on:

    • Device Description: Physical/optical properties of the lens material.
    • Indications for Use: What the contact lens is intended to correct.
    • Predicate Device: The existing device to which the new device is compared for substantial equivalence.
    • Regulatory Status: The FDA's determination of substantial equivalence.

    Without details on an AI/ML device and its associated performance study, I cannot generate the requested table or paragraphs.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1