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510(k) Data Aggregation

    K Number
    K071701
    Device Name
    TRACKLEAF-10
    Manufacturer
    DIREX SYSTEMS CORP.
    Date Cleared
    2007-07-23

    (32 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K052705,K040553
    Why did this record match?
    Device Name :

    TRACKLEAF-10

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

    TrackLeaf-10 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    TrackLeaf-10 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.

    Device Description

    TrackLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment.

    It enables shaping the Linac beam according to target geometrical and clinical requirements.

    The device is composed of the MMLC modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. »

    The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments.

    MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures.

    TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT).

    • Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary.
    • Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates.
    • DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.
    AI/ML Overview

    There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.

    The document is a 510(k) summary for a medical device (TrackLeaf-10, a Micro Multi-Leaf Collimator) that focuses on its substantial equivalence to predicate devices. It discusses the device's intended use, description, and classification, as well as regulatory compliance.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

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