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    K Number
    K030439
    Device Name
    HEADFIX
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2003-05-08

    (86 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K893707,K984365,K980201
    Why did this record match?
    Device Name :

    HEADFIX

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

    Positioning and repositioning of the patient's head; Stereotactic diagnostic localization; and Stereotactic radiotherapy of cranial targets

    Device Description

    The VBH HeadFIX™ is a fixation device for cranial stereotactic radiotherapy and radiosurgery. The major parts of the system include the Vacuum Pump, Vacuum Cushion, Target Positioner Screens and Baseplate, Post Set, and Cranial Localizer.

    AI/ML Overview

    The provided submission for K030439, concerning the VBH HeadFIX™, explicitly states that no performance data was required or requested by the Food and Drug Administration (Office of Device Evaluation) for this Class II device.

    Therefore, the following information, which requires specific performance study data, cannot be extracted from the given text:

    1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported performance data is provided.
    2. Sample sized used for the test set and the data provenance: No test set information is available.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
    4. Adjudication method for the test set: No adjudication method is described.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was conducted or reported. The device is a physical fixation device, not an AI-assisted diagnostic tool.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No such study was conducted or reported. The device is a physical fixation device, not an algorithm.
    7. The type of ground truth used: No ground truth information is available as no performance testing was required.
    8. The sample size for the training set: No training set information is available.
    9. How the ground truth for the training set was established: No ground truth establishment for a training set is described.

    The submission relies on a database search for adverse effects of similar, currently marketed devices rather than prospective performance testing of the VBH HeadFIX™.

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