LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233203
    Device Name
    Soft Tissue Augmentation Resorbable Matrix
    Manufacturer
    Collagen Matrix, Inc.
    Date Cleared
    2024-05-01

    (216 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

    STAR Matrix is indicated for:

    • Covering of implants placed in immediate or delayed extraction sockets;
    • Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
    Device Description

    The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Soft Tissue Augmentation Resorbable Matrix - STAR Matrix) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report for software as a medical device (SaMD) or AI/ML-driven devices.

    The document primarily covers:

    • Description of the device: A resorbable membrane for gingival augmentation.
    • Comparison to predicate devices: Highlighting similarities and differences in technical characteristics.
    • Performance data: Primarily non-clinical (in vitro, animal, biocompatibility, sterilization, shelf life).
    • No clinical studies were required to determine substantial equivalence for this device.

    Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the document does not describe such a study. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is typically found in documentation for the validation of AI/ML-based medical devices or devices demonstrating clinical efficacy/safety through trials, which is not the nature of this 510(k) submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1