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510(k) Data Aggregation

    K Number
    K971479
    Device Name
    DURALASTIC ANATOMICAL MALAR IMPLANTS
    Manufacturer
    ALLIED BIOMEDICAL CORP.
    Date Cleared
    1997-07-18

    (86 days)

    Product Code
    LZK,ESR,FWP
    Regulation Number
    878.3550
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K952707
    Why did this record match?
    Reference Devices :

    K952707

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

    The DuralaBtic Anatomical Chin Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery .

    Device Description

    Duralastic Malar implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. They are manufactured in pairs with a mirror image left and right. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has been biocompatibility, mutagenicity, thoroughly tested -for carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Malar Implants will be provided sterile and nonsterile.

    AI/ML Overview

    The provided text is a 510(k) premarket notification document for Duralastic Malar Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and results.

    Therefore, the document does not contain the information required to answer the prompt.

    Specifically, it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
    3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
    4. The type of ground truth used, or details about training sets.

    The document primarily describes the product, its intended use, physical properties, sterilization process, and concludes that it is substantially equivalent to a previously approved device (K952707) based on using the same molds and materials.

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