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510(k) Data Aggregation

    K Number
    K120760
    Device Name
    LDR SPINE SPINETUNE TL SPINAL SYSTEM
    Manufacturer
    LDR SPINE USA INC.
    Date Cleared
    2012-06-27

    (106 days)

    Product Code
    MNH,KWP,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K100575,K102331
    Why did this record match?
    Reference Devices :

    K100575, K102331

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

    The SpineTune™ TL Spinal System is a posterior, non-cervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

    • Spondylolisthesis (Grade 3 and 4) .
    • Degenerative spondylolisthesis with objective evidence of neurological . impairment
    • Trauma (i.e., fracture or dislocation)
    • Spinal stenosis .
    • Deformities or curvatures (i.e., scoliosis, . kyphosis, and/or lordosis)
    • Tumor .
    • Pseudoarthrosis .
    • Failed previous fusion .
    Device Description

    The SpineTune TL Spinal System is a top-loading posterior spinal pedicle fixation system consisting of various pedicle screws, rods, set screws, and transverse, lateral, axial, and domino type connectors. The 8.0mm and 8.5mm polyaxial screws are a design modification of the 8.0mm and 8.5m polyaxial screws cleared in the predicate SpineTune TL Spinal System (K100575, K102331). Cannulated 8.0mm and 8.5mm polyaxial screws, additional lengths of 7.5mm polvaxial, monoaxial, and reduction screws and curved rods, and several device specific instruments, are additions to the previously cleared SpineTune TL Spinal System.

    AI/ML Overview

    The provided text describes a 510(k) summary for the LDR Spine USA SpineTune TL Spinal System, focusing on mechanical non-clinical testing for substantial equivalence to a predicate device. It does not contain information about the performance of an AI/ML powered device, or any clinical study involving human readers or AI assistance. Therefore, it is impossible to answer the questions related to AI/ML device performance, human readers, or ground truth establishment based on the provided input.

    However, I can extract information related to the acceptance criteria for the mechanical tests:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test NameAcceptance CriteriaReported Device Performance
    Dynamic Compression Bending Test (ASTM F-1717)The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
    Flexion-Extension Cantilever Test (ASTM F-1798)The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
    Axial Gripping Capacity Test (ASTM F-1798)The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
    Overtightening Test (ASTM F-1798)The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.
    Static Torsion Test (ASTM F-1717)The proposed screws (8.0mm and 8.5mm diameter polyaxial screws) must meet the acceptance criteria set forth by the predicate SpineTune TL Spinal System (K100575, K102331).The results of these tests were compared to the predicate SpineTune TL Spinal System in order to verify that the proposed screws meet the acceptance criteria set forth by the predicate screws. The document states that "the device is as safe and effective, and performs as well or better than the legally marketed predicate device." It doesn't provide specific numerical performance values.

    Summary of the study:
    The study involved non-clinical mechanical testing of the modified 8.0mm and 8.5mm diameter polyaxial screws of the SpineTune TL Spinal System. The purpose was to demonstrate substantial equivalence to the predicate SpineTune TL Spinal System (K100575, K102331). The specific tests performed were Dynamic Compression Bending, Flexion-Extension Cantilever, Axial Gripping Capacity, Overtightening, and Static Torsion, all conforming to relevant ASTM standards. The conclusion was that the device met the acceptance criteria and performed as well or better than the predicate device.

    Information not available in the provided text:

    • 2. Sample sized used for the test set and the data provenance: The document does not specify the number of samples used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as it is non-clinical mechanical testing.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML powered device, and no "ground truth" in the context of expert review is mentioned.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    • 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: Not applicable. This is not an AI/ML powered device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
    • 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the performance standards and criteria set by the predicate device and relevant ASTM standards.
    • 8. The sample size for the training set: Not applicable as this is not an AI/ML powered device.
    • 9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML powered device.
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