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510(k) Data Aggregation

    K Number
    K162748
    Device Name
    MindMotionPRO
    Manufacturer
    MindMaze SA
    Date Cleared
    2017-04-24

    (206 days)

    Product Code
    LXJ
    Regulation Number
    890.5360
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MindMotionPRO

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

    MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a clinical environment and supervised by a medical professional trained in the proper utilization of the MindMotionPRO.

    Device Description

    MindMotionPRO is a 3D imaging and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of 3D virtual environments and avatars for visual feedback.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any such criteria. The document is a 510(k) clearance letter for the MindMotionPRO device, which primarily concerns the FDA's determination of substantial equivalence to a predicate device.

    The information you asked for, such as:

    • A table of acceptance criteria and reported device performance
    • Sample size and data provenance for a test set
    • Number and qualifications of experts for ground truth
    • Adjudication method
    • MRMC comparative effectiveness study results
    • Standalone performance
    • Type of ground truth used
    • Sample size and ground truth establishment for the training set

    is not present in this document. This letter focuses on regulatory clearance and does not detail the technical validation studies of the device.

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