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510(k) Data Aggregation

    K Number
    K020320
    Device Name
    RADIOSYSTEM/NT, MODEL 80-13020
    Manufacturer
    STYKER INSTRUMENTS
    Date Cleared
    2002-08-28

    (209 days)

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

    The RadioSystem/NT stereotactic planning software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-energetic photons. It is used for patients which are selected for a precise radiation therapeutical treatment of arbitrary parts of the human body according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers. In addition the planning of interstitial radiosurgery by implanting radioactive seeds inside of the target volume (Brachytherapy) and the planning of stereotactic approaches (Stereotaxy) will be supported.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving device performance.

    The document is an FDA 510(k) clearance letter for the "RadioSystem/NT V1.0" device, issued in 2002. This letter states that the device has been found substantially equivalent to legally marketed predicate devices.

    The content focuses on regulatory compliance, outlining:

    • The device name and regulation numbers.
    • The determination of substantial equivalence.
    • General controls and potential additional controls applicable to the device.
    • Contact information for various FDA offices.
    • The intended use of the device, which is a software-based planning system for radiation therapy and brachytherapy.

    The letter explicitly does not include any details about performance metrics, acceptance criteria, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. These elements are typically found in the 510(k) summary or detailed submission, which is not part of this clearance letter.

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