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510(k) Data Aggregation

    K Number
    K120796
    Device Name
    SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
    Manufacturer
    SUPERDIMENSION INC.
    Date Cleared
    2012-10-26

    (225 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

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

    The superDimension superLock Cobra is intended for use to radiographically mark soft tissue for future surgical therapeutic procedures.

    Device Description

    The superDimension superLock Cobra is an implantable marker intended to be used to radiographically mark soft tissue for future surgical or therapeutic purposes. The marker is placed at or near the intended treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is identified with respect to the marker. The superDimension superLock Cobra is manufactured of gold and nitinol. The marker is delivered in a sterile pre-loaded delivery cartridge. The device is intended for single use.

    AI/ML Overview

    The provided text is a 510(k) Summary for the superDimension superLock Cobra fiducial marker, alongside an FDA clearance letter and Indications for Use statement. This document describes the device and its intended use, but it is not a study report and therefore does not contain acceptance criteria or detailed study results for performance metrics traditionally associated with AI/algorithm performance studies.

    The "Performance Tests" section of the 510(k) Summary states: "Tests were performed to demonstrate substantial equivalence of the superDimension device in comparison to the predicated as follows: • Radiographic Visibility • Compatibility with imaging equipment (Cyberknife, OBI) • Migration resistance."

    However, it does not provide quantitative acceptance criteria or reported device performance data for these tests. The document concludes with a general statement: "The results of the nonclinical tests demonstrate that the superDimension superLock Cobra is as safe and effective as the legally marketed predicate devices, and performs as well as or better than the predicate device(s)."

    Therefore, I cannot fulfill your request for the specific points regarding acceptance criteria, reported performance, sample sizes, ground truth, or details of an AI/algorithm study because this information is not present in the provided text. The document describes a medical device clearance process based on substantial equivalence to predicate devices, focusing on safety and effectiveness, rather than a performance study of a diagnostic algorithm against specific quantitative metrics.

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