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510(k) Data Aggregation

    K Number
    K022404
    Device Name
    ACTIBAND
    Manufacturer
    PAW, LLC
    Date Cleared
    2002-08-08

    (16 days)

    Product Code
    ILX
    Regulation Number
    890.5290
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAW, LLC

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

    For the treatment of edema following Blepharoplasty

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Actiband™". It does not contain any information about acceptance criteria, device performance studies, or details relevant to statistical analysis or ground truth establishment. The letter primarily focuses on the regulatory aspects of the device's substantial equivalence and approval to market.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or MRMC studies from the provided text.

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