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510(k) Data Aggregation

    K Number
    K171633
    Device Name
    NuVasive TLX Interbody System
    Manufacturer
    NuVasive, Incorporated
    Date Cleared
    2017-09-28

    (118 days)

    Product Code
    MAX,PHM
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K170962,K153627,K141665,K071795,K161230,K140770
    Why did this record match?
    Device Name :

    NuVasive TLX Interbody System

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

    The NuVasive TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

    The TLX Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive TLX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

    Device Description

    The TLX Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NWasive TLX Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

    AI/ML Overview

    I apologize, but the provided text describes a medical device, the "NuVasive TLX Interbody System," which is a spinal implant. The document is a 510(k) premarket notification from the FDA regarding its clearance.

    This type of document does not contain information about:

    • AI/Algorithm performance evaluation. There are no acceptance criteria, performance metrics, or study details related to an AI device.
    • Sample sizes, data provenance, expert labeling, or ground truth establishment in the context of an algorithm's performance.
    • MRMC studies or standalone algorithm performance.

    The "Performance Data" section specifically mentions nonclinical testing related to the physical properties of the spinal implant (e.g., static and dynamic axial compression, push-out testing, subsidence analysis) to demonstrate its equivalence to predicate devices, not the performance of an AI or diagnostic algorithm.

    Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets those criteria from the provided text. The text describes the approval of a physical medical implant, not a software or AI diagnostic tool.

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