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510(k) Data Aggregation

    K Number
    K061934
    Device Name
    XTAC
    Manufacturer
    OSTEOGENICS, INC.
    Date Cleared
    2007-07-17

    (375 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XTAC

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

    The XTAC is indicated for the temporary bridging of fascial defects where primary closure is not possible, including, but not limited to, abdominal compartment syndrome.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a surgical mesh device, XTAC™. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria, as one would find for an AI/ML powered medical device.

    The letter states that the device is substantially equivalent to legally marketed predicate devices, which means it has been found to be as safe and effective as a device already on the market. For this type of device (surgical mesh), substantial equivalence is typically demonstrated through a comparison of technological characteristics, materials, and intended use with the predicate device, rather than through performance metrics like sensitivity, specificity, or F1-score which are relevant for AI/ML devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment, as this document pertains to a traditional medical device clearance and not an AI/ML product.

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