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510(k) Data Aggregation

    K Number
    K113366
    Device Name
    LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
    Manufacturer
    PHYGEN, LLC
    Date Cleared
    2012-01-17

    (63 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K110588
    Predicate For
    K182339
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LEUCADIA AutoLok™ Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

    Device Description

    The Leucadia AutoLok™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia AutoLok™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Multi-axial AutoLok™ screws are supplied in 5mm, 6mm, 7mm and 8 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The unique pedicle screw and set screw interface is designed to prevent backout of the set screw from the construct. The Leucadia AutoLok™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia AutoLok™ Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia AutoLok™ Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia AutoLok™ Pedicle Screw System components should not be reused.

    AI/ML Overview

    The provided text describes a medical device, the LEUCADIA AutoLok™ Pedicle Screw System, and its substantial equivalence to a predicate device, rather than an AI/ML-driven device requiring extensive performance studies as outlined in your request. Therefore, most of the requested fields are not applicable to the information given.

    However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the provided content.

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Mechanical performance equivalent to the predicate device and/or other similar implants, sufficient for in vivo loading.Biomechanical tests per ASTM F1717-11 (Static Compression Bending, Static Torsion, and Dynamic Compression Bending) and ASTM F1798-97 (2008) (Static Axial Gripping Capacity, Static A-P and Static Axial Torque) were performed. The test results were equivalent to the predicate device and/or other similar implants.

    Regarding the other requested information:

    • 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is a mechanical implant, and its performance was evaluated through biomechanical tests, not based on a clinical test set of patient data.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical devices is established through engineering standards and testing, not expert consensus on clinical data.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a mechanical device's performance testing.
    • 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 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 device.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this mechanical device, the ground truth is established by the specified ASTM (American Society for Testing and Materials) standards for biomechanical properties.
    • 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
    • 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

    Summary:

    The LEUCADIA AutoLok™ Pedicle Screw System's acceptance criteria are based on its mechanical performance relative to a predicate device and established ASTM standards. The study proving this involved biomechanical testing, demonstrating equivalence to the predicate device. The information provided does not pertain to an AI/ML medical device, and therefore many of the requested fields are not relevant.

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