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510(k) Data Aggregation

    K Number
    K160209
    Device Name
    Gold Anchor
    Manufacturer
    NASLUND MEDICAL AB
    Date Cleared
    2016-06-21

    (145 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K091645,K070305
    Predicate For
    K201117
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

    Device Description

    The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

    AI/ML Overview

    I'm sorry, but the provided text does not contain the specific information required to answer your request. The document is an FDA 510(k) summary for a medical device (Gold Anchor), which focuses on demonstrating substantial equivalence to a predicate device. It details the device's description, indications for use, comparison to predicate devices, and performance data related to MRI safety and biocompatibility.

    The text does not include:

    • A table of acceptance criteria and reported device performance in the context of clinical or diagnostic accuracy.
    • Details about a study proving the device meets acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
    • Information on sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for diagnostic performance. The performance data mentioned is related to MRI compatibility and biocompatibility, not clinical accuracy as would be relevant for AI/diagnostic devices.
    • Training set details.

    This document describes a passive fiducial marker, not an AI-powered diagnostic device, so the requested information about diagnostic performance, AI studies, and ground truth establishment is not applicable to the content provided.

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