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    K Number
    K980444
    Device Name
    SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
    Manufacturer
    SPECTRUM DESIGNS, INC.
    Date Cleared
    1998-05-06

    (90 days)

    Product Code
    FWP
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT

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

    The Spectrum Designs Bilateral Groove Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

    Device Description

    The Spectrum Designs Bilateral Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification summary for a medical device, specifically the Spectrum Designs Bilateral Groove Chin Implant. It is not an AI/ML device, and therefore the majority of the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from the provided text.

    The document discusses the device's description, indications for use, contraindications, and potential warnings/precautions. It then details the FDA's decision regarding substantial equivalence to predicate devices. There is no mention of an algorithm, AI, or any performance study based on quantitative metrics typically associated with AI/ML device submissions.

    Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and acceptance criteria. The provided text does not contain that type of information.

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