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510(k) Data Aggregation

    K Number
    K091011
    Device Name
    PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")
    Date Cleared
    2009-04-22

    (13 days)

    Product Code
    FWP,LZK
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K933367,K021889,K983754,K983755,K983756,K002886
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC ("STL")

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

    PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

    Device Description

    The PureForm ePTFE Facial Implants are threedimensional facial prosthesis (Nasal, Chin, and Malar) that are made from expanded Polytetraflouroethylene (ePTFE). The device is offered sterile in multiple sizes.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets those criteria.

    The document is a 510(k) summary for a medical device (PureForm ePTFE Facial Implants). This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a performance study with defined acceptance criteria.

    The key points of the provided text are:

    • Identification of the device: PureForm ePTFE Facial Implants (Nasal, Chin, Malar)
    • Applicant: Surgical Technology Laboratories, Inc.
    • Date Prepared: April 8, 2009
    • Predicate Devices: Several existing facial implants.
    • Conclusion: The device is deemed substantially equivalent to the predicate devices based on indications, intended use, material, design, and biocompatibility. This is a regulatory finding, not a demonstration of performance against specific, quantitative acceptance criteria through a study.
    • FDA Letter: The FDA letter confirms the substantial equivalence determination but does not mention any performance studies or acceptance criteria met by the device.

    Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study types because the provided text does not contain this information.

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