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510(k) Data Aggregation

    K Number
    K220324
    Device Name
    AccuFit Lateral 2-Hole Plate
    Manufacturer
    Precision Spine, Inc.
    Date Cleared
    2022-03-16

    (41 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K162211,K150449
    Why did this record match?
    Device Name :

    AccuFit Lateral 2-Hole Plate

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

    The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

    Device Description

    The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.

    AI/ML Overview

    The provided text describes a medical device (AccuFit® Lateral 2-Hole Plate) and its 510(k) clearance by the FDA based on substantial equivalence to predicate devices. It does not present information related to the performance of an AI/ML-enabled device, nor does it detail a study involving human readers or expert ground truth establishment for a diagnostic algorithm.

    Therefore, I cannot extract the information required in your request about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader studies. The document pertains to a physical spinal implant, not an AI-based diagnostic tool.

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