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510(k) Data Aggregation

    K Number
    K181397
    Device Name
    DualX
    Manufacturer
    Innovasive, Inc.
    Date Cleared
    2018-09-27

    (121 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K123281,K152651,K120966,K171519,K161379,K113447
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovasive, Inc.

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

    The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualXTM PLIF is indicated for unilateral or Bilateral implantation.

    The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    Device Description

    The DualX Implants are an expanding family of Interbody Fusion Devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery and, in the collapsed configuration, are between 12.3 mm wide (TLIF and PLIF) and 13.3mm wide (LLIF). After entering the joint space, the implants expand laterally to maximize the contact area around the cortical rim of the vertebral bodies. The implants then expand vertically to maintain destraction of the vertebral bodies and maximize clearance for exiting nerve roots. The implants are binary, and each implant can only be locked out in the fully expanded state. Specific sizes are included in the system with various expanded heights to optimize the fit for the patient. DualX Lumbar Intervertebral Body Fusion Device is made from titanium that conforms to ASTM F136.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the DualX™ intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data, primarily mechanical testing. It does not describe a study involving a medical AI device for diagnosis or prognosis, nor does it present clinical study data with acceptance criteria for such a device.

    Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to:

    1. Acceptance criteria and device performance for an AI/diagnostic device. The document discusses mechanical test results for an implantable device, not accuracy metrics for an AI.
    2. Sample size and data provenance for a test set. The data discussed is from physical, mechanical testing of the implant, not patient data for AI model evaluation.
    3. Number of experts and their qualifications for ground truth. Not applicable to mechanical testing.
    4. Adjudication method for the test set. Not applicable to mechanical testing.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable.
    6. Standalone (algorithm only) performance. Not applicable.
    7. Type of ground truth used. "Ground truth" in this context refers to the defined test conditions for mechanical properties, not expert consensus or pathology on patient data.
    8. Sample size for the training set. Not applicable, as this is not an AI device.
    9. How ground truth for the training set was established. Not applicable.

    The "Performance Data" section explicitly states that "The DualX Lumbar Intervertebral Body Fusion Device has been tested in the following test modes: Static axial compression per ASTM F2077, Static compressive shear per ASTM F2077, Dynamic axial compression per ASTM F2077, Dynamic compressive shear per ASTM F2077, Subsidence per ASTM F2267, Expulsion. The results of this non-clinical testing show that the strength of the DualX Lumbar Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This is all mechanical testing, not a clinical or AI performance study.

    In summary, the provided document is not relevant to the type of device or study described in your prompt.

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