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510(k) Data Aggregation

    K Number
    K191423
    Device Name
    Normandy VBR System
    Manufacturer
    Zavation Medical Products LLC
    Date Cleared
    2019-08-06

    (69 days)

    Product Code
    PLR,MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K180673,K060416,K142205
    Why did this record match?
    Reference Devices :

    K180673, K060416, K142205

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

    The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

    The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

    The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate systems). When used at more than two levels, supplemental fixation should include posterior fixation.

    Device Description

    The Normandy VBR System is an adjustable height vertebral body replacement device that is implanted into the vertebral body space to provide structural stability in skeletally mature patients following corpectomy or vertebrectomy. The system is comprised of spacers of various sizes and options to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. The device is mechanically locked at the required height by means of a locking screw. Each spacer has an axial hole to allow autograft or allograft to be packed inside each spacer. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Components are manufactured from titanium alloy (Ti-6AL-4V) per ASTM F-136.

    AI/ML Overview

    The provided text describes a medical device, the Normandy VBR System, and its substantial equivalence determination by the FDA. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning an AI/algorithm's performance.

    The document is a 510(k) premarket notification approval letter and summary for a spinal implant. It focuses on demonstrating that the Normandy VBR System is substantially equivalent to existing predicate devices based on design, intended use, material composition, function, and mechanical performance.

    Therefore, I cannot fulfill your request for information regarding AI device acceptance criteria and a study proving an AI device meets them. The provided text does not describe an AI medical device or its performance evaluation in the context you've outlined.

    Here's what the document does provide the closest to your request, but is entirely in the context of a physical medical device (spinal implant) and its mechanical testing, not AI:

    1. A table of acceptance criteria and the reported device performance:

    Test MethodAcceptance CriteriaReported Device Performance
    Static and Dynamic Axial CompressionPassed (Substantially equivalent to predicate devices)Demonstrated substantial equivalence to predicate devices.
    Static and Dynamic TorsionPassed per ASTM F2077 (Substantially equivalent to predicate devices)Demonstrated substantial equivalence to predicate devices.
    SubsidencePassed per ASTM F2267 (Substantially equivalent to predicate devices)Demonstrated substantial equivalence to predicate devices.
    ExpulsionPassed (Substantially equivalent to predicate devices)Demonstrated substantial equivalence to predicate devices.

    Important Note: The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate devices through mechanical testing. The document doesn't provide specific quantitative thresholds for these tests but rather states that the "mechanical test results demonstrated that the Normandy VBR System is substantially equivalent to the predicate devices."

    The following points cannot be addressed as the provided text pertains to a physical spinal implant, not an AI/algorithmic device:

    1. Sample size used for the test set and the data provenance
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    3. Adjudication method
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    6. The type of ground truth used
    7. The sample size for the training set
    8. How the ground truth for the training set was established
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