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    K Number
    K140055
    Device Name
    ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
    Manufacturer
    TITAN SPINE, LLC
    Date Cleared
    2014-07-02

    (173 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K102067,K032812,K071795
    Why did this record match?
    Device Name :

    ENDOSKELETON(R) TL INTERBODY FUSION DEVICE

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

    The Endoskeleton® TL IBD is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. This device is intended for use supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

    Device Description

    The Endoskeleton® TL Interbody Fusion Device (IBD) implants are available in a various sizes with a variety of lordotic angles (0, 7 or 12 degrees), to accommodate patient anatomy. Lengths range from 40 to 60mm, widths from 18 to 26m and heights range from 8 to 16mm. Endoskeleton® TL IBD implants are intended for treatment in Lateral Lumbar Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a farge hollow region in the center to house bone graft material. The new bone formation through the implant is intended to provide long-term structural support and biologic fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces are acid etched to improve fixation to the adjacent bone. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI).

    AI/ML Overview

    Here's an analysis of the provided text regarding the Endoskeleton® TL Interbody Fusion Device, focusing on acceptance criteria and supporting studies:

    It's important to note that this document is a 510(k) Summary for a medical device seeking clearance, not a detailed research paper. Therefore, the depth of information regarding clinical studies, ground truth establishment, and expert qualifications is much less than what would be found in a peer-reviewed publication. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials for a novel device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria/Tests PerformedReported Device Performance
    Mechanical PerformanceStatic Compression-Shear (per ASTM F2077)Shown to be substantially equivalent to predicate interbody devices.
    Static Torsion (per ASTM F2077)Shown to be substantially equivalent to predicate interbody devices.
    Subsidence (per ASTM F2077)Shown to be substantially equivalent to predicate interbody devices.
    Expulsion (per ASTM F2077)Shown to be substantially equivalent to predicate interbody devices.
    Dynamic Compression (per ASTM F2267)Shown to be substantially equivalent to predicate interbody devices.
    Dynamic Compression-Shear (per ASTM F2267)Shown to be substantially equivalent to predicate interbody devices.
    Dynamic Torsion (per ASTM F2267)Shown to be substantially equivalent to predicate interbody devices.
    Biocompatibility(Implied) Manufactured from medical grade titanium alloy (Ti-6Al-AV-ELI)Accepted by the FDA, implying biocompatibility is established for this material.
    Material/Design Equiv.Indications for Use, Design, Dimensions, Materials (to predicate devices)All inclusive of the subject device (indicated as substantially equivalent).
    Safety/EffectivenessDoes not raise new questions about safety and effectiveness.Concluded that the subject device does not raise new questions.

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

    • Sample Size: The document does not specify a "test set" in the context of human subjects or clinical data. The performance testing described (mechanical testing) likely used device prototypes or manufactured samples. The number of samples for each mechanical test is not provided.
    • Data Provenance: Not applicable in the context of a clinical test set. The mechanical testing was performed in vitro, presumably by Titan Spine, LLC or a contracted lab. There is no mention of country of origin for clinical data, as no clinical study is detailed.
    • Retrospective/Prospective: Not applicable, as no clinical study is described. The mechanical tests are inherently retrospective in the sense that they are performed on manufactured devices.

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

    • This information is not provided in the document. For mechanical testing, the "ground truth" is typically defined by the test standards (ASTM F2077, ASTM F2267) and the performance of the predicate device. There were no human experts establishing a clinical ground truth for this type of submission.

    4. Adjudication Method for the Test Set

    • This information is not provided and is not applicable to the type of mechanical performance testing described. Adjudication methods are typically used in clinical studies for interpreting ambiguous findings, which is not the case here.

    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, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral fusion device, not an AI software or diagnostic imaging tool that would involve human readers or AI assistance.

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

    • No, a standalone performance study was not done. This refers to AI algorithms. The device is a physical implant.

    7. The Type of Ground Truth Used

    • For the mechanical testing, the "ground truth" was established by established ASTM standards (F2077, F2267) and the performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the subject device met or exceeded the performance of the predicates under these standardized conditions.

    8. The Sample Size for the Training Set

    • This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical implant, and the submission does not involve AI or machine learning.

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

    • This information is not applicable. As there is no AI component, there is no training set or associated ground truth.
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