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510(k) Data Aggregation

    K Number
    K123045
    Device Name
    BRIGADE STANDALONE SYSTEM
    Manufacturer
    NUVASIVE, INC.
    Date Cleared
    2013-04-16

    (197 days)

    Product Code
    OVD
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100043,K071309,K071795
    Predicate For
    K140479,K141665,K141942,K142487,K150135,K151214,K152943,K153782,K160051,K160597,K163269,K171689,K181386,K181531,K192047,K211935
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Brigade Hyperlordotic System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Brigade Hyperlordotic System is intended for use with autograft. The Brigade Hyperlordotic System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

    Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Brigade Hyperlordotic System.

    Device Description

    The NuVasive Brigade Hyperlordotic System is an interbody system manufactured from PEEK and titanium alloy conforming to industry recognized standards. The NuVasive Brigade Hyperlordotic System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Brigade Hyperlordotic intervertebral fusion device is a device composed of a PEEK interbody implant containing radiographic titanium alloy markers, and four (4) titanium alloy bone screws. The subject device components are made from Polyetheretherketone (PEEK-OPTIMA LT1) conforming to ASTM F-2026 and titanium alloy (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3.

    AI/ML Overview

    The NuVasive® Brigade® Hyperlordotic System is an intervertebral body fusion device. The provided text describes the nonclinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study establishing performance against specific acceptance criteria for a new clinical endpoint.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Test Standard / ParameterReported Device Performance
    Mechanical Strength (Static & Dynamic)Static and dynamic compression, torsion, and compression shear testing per ASTM F2077All test results passed acceptance criteria
    Expulsion ResistanceExpulsion testing per ASTM Work Item Z8423ZAll test results passed acceptance criteria
    Subsidence ResistanceSubsidence testing per ASTM F2267All test results passed acceptance criteria
    Biocompatibility/Material IntegrityWear debris/mass change analysis during ASTM F2077, per ASTM F1714 and ASTM F1877All test results passed acceptance criteria
    Screw Fixation StrengthScrew push-out testingAll test results passed acceptance criteria
    Overall PerformanceMeets or exceeds the performance of the predicate device and does not introduce any new risksSystem is substantially equivalent to the predicate device

    2. Sample Size Used for the Test Set and Data Provenance

    The document details nonclinical (preclinical) testing, not a clinical study with a "test set" of patients. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned are laboratory-based mechanical and material assessments.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not applicable. The "ground truth" for the nonclinical tests is based on established engineering standards (e.g., ASTM standards) and the performance of the predicate device for comparison. There is no mention of expert adjudication for these engineering tests.

    4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

    Not applicable, as this was a nonclinical study based on standardized tests.

    5. 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

    No MRMC study was performed or mentioned. This device is a physical intervertebral body fusion device, not an AI-based diagnostic or assistive software.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Not applicable. This device is a physical implant.

    7. The Type of Ground Truth Used

    The "ground truth" for the nonclinical tests was based on established engineering standards (ASTM and ISO) and the performance metrics of the legally marketed predicate devices. The goal was to demonstrate that the subject device's performance meets or exceeds these established benchmarks.

    8. The Sample Size for the Training Set

    Not applicable. This is a physical device, and the testing described is nonclinical. There is no "training set" in the context of machine learning or AI algorithms.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. No training set was used.

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