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510(k) Data Aggregation

    K Number
    K190418
    Device Name
    NuVasive® VersaTie® System
    Manufacturer
    NuVasive, Incorporated
    Date Cleared
    2019-03-21

    (28 days)

    Product Code
    OWI
    Regulation Number
    888.3010
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K151374,K173117
    Why did this record match?
    Reference Devices :

    K151374

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

    The VersaTie System is a temporary implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

    1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.

    2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis.

    3. Spinal degenerative surgery, as an adjunct to spinal fusions.

    The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt chromium alloy whenever "wiring" may help secure the attachment of the other implants.

    Device Description

    The VersaTie System is part of a spinal posterior fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is comprised of braided bands, clamps and set screws designed to attach to titanium alloy or cobalt-chromium alloy rods. The purpose of this submission is to introduce design modifications to previously cleared components and add new sterilization method for the clamp component to previously cleared VersaTie System.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive® VersaTie® System. This device is a bone fixation cerclage system, which is a temporary implant used in orthopedic surgery for spinal stabilization and fracture repair.

    The document describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets specific acceptance criteria related to AI/software performance, nor does it discuss ground truth establishment, expert adjudication, or MRMC studies.

    The section "Performance Data" states:
    "Gamma sterilization validation, sterile packaging validation, integrity of the sterile barrier over time validation are performed to qualify new packaging and sterilization method for the VersaTie System. The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate."

    This clearly indicates that the "performance data" refers to physical properties and sterilization aspects of the medical device, not the performance of an AI or software component.

    Therefore, I cannot fulfill your request for:

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

    This document describes a traditional medical device submission, not one for an AI/ML-enabled device.

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