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510(k) Data Aggregation

    K Number
    K983831
    Device Name
    VECTORVISION2
    Manufacturer
    BRAINLAB, AG
    Date Cleared
    1999-05-19

    (201 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VECTORVISION2

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

    BrainLAB VectorVision Spider is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient 's images data being processed by a VectorVision Spider workstation. The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a CT, MR or X-ray based model of the anatomy.

    Device Description

    BrainLAB VectorVision Spider is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient 's images data being processed by a VectorVision Spider workstation.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Vector Vision2 (BrainLAB Navigation System)". This letter indicates regulatory clearance based on substantial equivalence to a predicate device, rather than providing a detailed technical study report with specific acceptance criteria and performance data.

    Therefore, the input does not contain the information required to answer the questions regarding acceptance criteria, device performance, study details (sample size, data provenance, expert details, adjudication methods, MRMC study, standalone performance), or ground truth establishment.

    The document is a regulatory approval letter and not a scientific or clinical study report.

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