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510(k) Data Aggregation

    K Number
    K210573
    Device Name
    Velofix SA Cervical Cage
    Manufacturer
    U&I Corporation
    Date Cleared
    2021-11-19

    (266 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K172424,K122872
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

    Device Description

    The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw. The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate. The Velofix™ SA Cervical Cage has three types: 1) All PEEK Type, 2) Ti plate Type, 3) Ti plate-N type. The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter and summary for the Velofix™ SA Cervical Cage. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical performance testing.

    However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance. The entire document focuses on the mechanical and material properties of an intervertebral fusion device.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance (for software/AI).
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth for software.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is for a medical device (an implantable cage), not a software or AI product. The "performance testing" mentioned refers to mechanical strength evaluation of the physical implant, not algorithmic performance.

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