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510(k) Data Aggregation

    K Number
    K193378
    Device Name
    CarboClear Lumbar Cage System
    Manufacturer
    CarboFix Orthopedics Ltd.
    Date Cleared
    2020-03-02

    (88 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K192214,K173487,K182377,K151773,K152475,K172480
    Predicate For
    K203683
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

    CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.

    Patients should have at least six months of non-operative treatment prior to surgery.

    Device Description

    CarboClear® Lumbar Cage System is composed of implants of various sizes, and instruments.

    The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.

    AI/ML Overview

    Unfortunately, the provided text does not contain the specific information required to answer your request about acceptance criteria for an AI/ML powered medical device and the study that proves it meets those criteria.

    The document is a 510(k) summary for the "CarboClear® Lumbar Cage System," which is an intervertebral body fusion device made of carbon fiber-reinforced PEEK and titanium alloy. This is a physical implant, not an AI/ML powered device.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance related to AI/ML.
    2. Details about sample size, data provenance, expert qualifications for test set ground truth, or adjudication methods for an AI/ML study.
    3. Information on MRMC studies or effect sizes of AI assistance.
    4. Details on standalone algorithm performance.
    5. Type of ground truth used for AI/ML.
    6. Sample size and ground truth establishment for an AI/ML training set.

    The document does mention performance data for the CarboClear® Lumbar Cage System, which includes mechanical tests like static and dynamic axial compression, compression-shear, wear evaluation, subsidence, expulsion, and endplate shear tests. These are standard tests for spinal implants, demonstrating the physical device's mechanical integrity and similarity to predicate devices. However, this is not related to AI/ML performance.

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