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510(k) Data Aggregation

    K Number
    K050250
    Device Name
    AQUIFY MULTIPURPOSE SOLUTION
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2005-08-10

    (188 days)

    Product Code
    LPN
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AQUIFY MULTIPURPOSE SOLUTION

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

    AQuify® Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify is also indicated for daily protein removal when lenses are soaked for at least 4 hours.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called Aquify® Multipurpose Solution. This document is related to regulatory approval for a contact lens care product and does not contain information about the performance of an AI/ML powered device, its acceptance criteria, or any associated studies.

    Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document.

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