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    K Number
    K120355
    Device Name
    LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM
    Manufacturer
    PHYGEN, LLC
    Date Cleared
    2012-03-07

    (30 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K110588
    Why did this record match?
    Device Name :

    LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM

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

    The LEUCADIA™ 4.5 mm 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™ 4.5 mm 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™ 4.5 mm Pedicle Screw System consists of 4.5 mm diameter screws, which are available in 7 different lengths: 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, and 55 mm. All sizes are able to receive 5.5mm connecting rods only. The Leucadia™ 4.5 mm Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ 4.5 mm Pedicle Screw System is a temporary implant system intended to be removed after solid fusion has occurred. Leucadia™ 4.5 mm Pedicle Screw System implant components are an addition to the existing Leucadia™ Pedicle Screw System (K110588 - S/E May 25, 2011). It should not be used with components from any other manufacturer. As with all orthopedic implants, Leucadia™ 4.5 mm Pedicle Screw System components should not be reused.

    AI/ML Overview

    The Leucadia™ 4.5 mm Pedicle Screw System is intended to help correct, immobilize, and stabilize spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral space.

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

    Acceptance Criteria (Predicate Device K110588)Reported Device Performance (LEUCADIA™ 4.5 mm Pedicle Screw System)
    Mechanical tests equivalent to or better than the predicate device for static compression bending, static torsion, dynamic compression bending, and screw pullout.Test results for Static Compression Bending, Static Torsion, Dynamic Compression Bending, and Screw Pullout per ASTM F1717-10 and ASTM F543-07 were confirmed to be equivalent to the predicate device and/or other similar implants. The results are sufficient for in vivo loading.

    2. Sample size used for the test set and the data provenance

    The sample size is not explicitly stated, but the testing involved biomechanical tests compliant with ASTM standards. The data provenance is from laboratory testing of the device and its predicate, conducted by Phygen, LLC, a US-based company. These are prospective tests performed specifically for this submission.

    3. Number of experts used to establish the ground truth for the test set and qualifications

    Not applicable. The ground truth for this device is based on standardized biomechanical testing (ASTM standards), not expert medical opinion on clinical images or patient data.

    4. Adjudication method for the test set

    Not applicable. This device relies on objective mechanical testing against established industry standards.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

    No, a multi-reader multi-case comparative effectiveness study was not done. This is a medical device (spinal implant) and its performance is evaluated through biomechanical testing, not through human reader interpretation of data or images.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Yes, a "standalone" evaluation was performed, meaning the device's mechanical properties were tested independently without human interaction influencing the test results.

    7. The type of ground truth used

    The ground truth used for proving the device meets acceptance criteria is based on:

    • Established ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F1717-10 for Static Compression Bending, Static Torsion, and Dynamic Compression Bending, and ASTM F543-07 for Screw Pullout Tests. These standards define the methodologies and expected performance parameters for spinal implant devices.
    • Comparative equivalence: The device's performance was compared against the predicate device (LEUCADIA™ Pedicle Screw System, K110588) and/or other similar implants, demonstrating equivalent mechanical properties sufficient for in vivo loading.

    8. The sample size for the training set

    Not applicable. This device is a mechanical implant; therefore, no "training set" in the context of machine learning or AI is relevant.

    9. How the ground truth for the training set was established

    Not applicable, as there is no training set for this type of device.

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