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    K Number
    K161230
    Device Name
    NuVasive Lumbar Interbody Implants
    Manufacturer
    NUVASIVE, INCORPORATED
    Date Cleared
    2016-08-25

    (115 days)

    Product Code
    MAX,OVD
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K153782,K141896,K153419,K160051
    Why did this record match?
    Device Name :

    NuVasive Lumbar Interbody Implants

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

    NuVasive® Lumbar Non-Interfixated Interbody Implants:

    The NuVasive Lumbar Interbody Implants are 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 Lumbar Interbody Implants (XL platform) are intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and the Lumbar Interbody Implants (XL and L platforms) are 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 Lumbar Interbody Implants (XL and L platforms) are also indicated for use in the treatment of multilevel degenerative scoliosis in the thoracolumbar spine.

    NuVasive® Lumbar Interfixated Interbody Implants:

    CoRoent XL-F System:

    The NuVasive Lumbar Interbody Implants (CoRoent XL-F platform) are 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 a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The devices are to be used in patients who have had at least six months of non-operative treatment.

    The CoRoent XL-F platform implants are intended for use in interbody fusions in the lumbar spine from L2 to L5, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The CoRoent XL-F platform implants can also be used as an adjunct for fusion in patients diagnosed with multilevel degenerative scoliosis.

    Brigade System:

    The NuVasive Lumbar Interbody Implants (Brigade System platform) are indicated for spinal fusion procedures in skeletally mature patients. The Brigade Standalone System (lordotic angles of 8° and 12°) is a standalone system. The Brigade Hyperlordotic System (lordotic angles of 15° to 30°) must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The System is designed for use with autogenous and/or allogeneic bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

    The Lumbar Interbody Implants (Brigade System platform) are intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Brigade System platform implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. However, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the Brigade System platform must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

    Device Description

    The subject NuVasive Lumbar Interbody Implants are interbody implants manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026. Additinally, CoRoent Ti-C implants are PEEK devices with a commercially pure titanium (CP Ti) coating applied to the superior and inferior surfaces of the device. The PEEK devices contain titanium alloy radiographic markers conforming to ASTM F136 or ASTM F1472 or tantalum markers conforming to ASTM 560 or ISO 13782. The device's hollow core or graft aperture allows for packing of graft material to help promote a solid fusion. Small spikes or teeth on each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device.

    The interfixated version of the subject NuVasive Lumbar Interbody Implants devices are composed of an interbody device manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026, MP35N conforming to ASTM F562, and titanium alloy conforming to ASTM F136 and ISO 5832-3. The Lumbar Interfixated Interbody System implants have four screw holes in the anterior wall of the PEEK implant that allow titanium alloy screws to be placed in the cranial and caudal vertebral bodies or one or two integrated tabs to allow a titanium alloy screw to be placed in the cranial and caudal vertebral bodies. Additionally, implants include titanium alloy radiographic markers conforming to industry recognized standards.

    The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. In addition to the integrated screws, the device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

    AI/ML Overview

    This document describes the NuVasive® Lumbar Interbody Implants and its 510(k) submission for FDA clearance. It does not contain information about the acceptance criteria or a specific study proving the device meets acceptance criteria in the way typically seen for AI/ML device performance. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for spinal fusion applications.

    Therefore, many of the requested sections about acceptance criteria, performance metrics, ground truth, and study parameters for an AI/ML device cannot be answered from the provided text.

    However, I can extract the relevant information from a regulatory perspective:

    Regulatory Context: This is a premarket notification (510(k)) to the FDA, which assesses substantial equivalence to a predicate device, rather than requiring de novo proof of safety and effectiveness against specific, novel acceptance criteria defined by performance metrics. The "acceptance criteria" here are effectively proving that the new device is as safe and effective as existing legally marketed devices for its intended use.

    Here's what can be answered based on the provided text, with an explanation of why other sections cannot be addressed:

    Acceptance Criteria and Device Performance (Regulatory Equivalence)

    Criterion (Implicit for 510(k))Reported Device Performance (as claimed for Substantial Equivalence)
    1. Intended Use EquivalenceThe NuVasive® Lumbar Interbody Implants have indications for use that are substantially equivalent to the predicate devices, covering intervertebral body fusion, treatment of DDD, degenerative spondylolisthesis, and multilevel degenerative scoliosis in the thoracolumbar and lumbar spine.
    2. Technological Characteristics EquivalenceThe device's design, material composition (PEEK-Optima® LT-1, MP35N, titanium alloy, tantalum markers), and function are substantially equivalent to predicate devices. It does not contain software or electrical equipment.
    3. Mechanical Performance EquivalencePreviously presented mechanical testing data from predicate 510(k) submissions were deemed sufficient to support the proposed use. No new mechanical testing was performed as no new device designs or worst-case sizes were introduced, and the expanded indications (use of allograft, treatment of lumbar spondylolisthesis) do not create a new mechanical worst-case.
    4. Safety and Effectiveness Profile EquivalenceA retrospective clinical analysis (literature review) determined that the safety and effectiveness profile for the NuVasive Lumbar Interbody Implants used in the treatment of lumbar spondylolisthesis is similar to the predicate devices.

    Study Details Related to Substantial Equivalence Assessment:

    1. Sample size used for the test set and the data provenance:

      • Test Set Sample Size: Not applicable in the context of an AI/ML test set. For the mechanical testing, it states "worst case devices included with the subject system were tested and cleared in these predicate 510(k) submissions." Specific numbers are not provided.
      • Data Provenance: The retrospective clinical analysis was "Based on the published clinical literature review." This implies data from various sources within the literature, but specific countries of origin or if it was primary data collection are not specified. It was retrospective.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There was no "ground truth" derived by experts in the context of an AI/ML device for this submission. The "ground truth" for a 510(k) is essentially the established safety and effectiveness of the predicate device and the clinical understanding of the spinal fusion procedure.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no expert adjudication of a test set in the AI/ML sense.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI/ML diagnostic or assistive tool for human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the 510(k) review is the established performance of predicate devices and general clinical understanding of spinal fusion and related conditions from existing literature.

    7. The sample size for the training set: Not applicable. There was no AI/ML training set.

    8. How the ground truth for the training set was established: Not applicable.

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