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510(k) Data Aggregation

    K Number
    K240951
    Device Name
    Invictus Robotic Navigation Instruments
    Manufacturer
    Alphatec Spine
    Date Cleared
    2024-06-06

    (59 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K161363,K203742,K083416,K111449,K124058,K232044,K232275,K171651
    Why did this record match?
    Reference Devices :

    K161363, K203742, K083416, K111449, K124058

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

    The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spationing and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

    Device Description

    The Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.

    AI/ML Overview

    The provided text is a 510(k) summary for the Invictus Robotic Navigation Instruments. It explains that the determination of substantial equivalence (SE) is not based on an assessment of clinical performance data. Instead, it states that the device was evaluated through dimensional analysis and geometric comparison to the predicate devices to establish safety and effectiveness for accuracy performance.

    Therefore, the document does not contain the information requested concerning acceptance criteria, device performance, test set sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for training sets.

    The relevant section states:
    "Clinical Information
    Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

    VII. PERFORMANCE DATA
    The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance."

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