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510(k) Data Aggregation

    K Number
    K121016
    Device Name
    RANGE SPINAL SYSTEM (MESA AND DENALI)
    Manufacturer
    K2M, INC.
    Date Cleared
    2012-06-27

    (84 days)

    Product Code
    MNH,KWP,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111571,K070229,K072914,K080792,K081381,K100851,K110991,K112037
    Predicate For
    K130330,K141147
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

    Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

    Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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); tumor; pseudoarthrosis; and failed previous fusion.

    Device Description

    The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add larger Mesa screws, transition rods, hooks, transverse connectors and rod connectors to the system.

    Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

    Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

    AI/ML Overview

    The provide 510(k) summary does not contain information typically associated with the acceptance criteria and study design for AI/ML devices, such as performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training data, expert qualifications, or details about standalone or MRMC studies.

    Instead, this document describes a traditional medical device (Range Spinal System - spinal fixation system components) and its submission for 510(k) clearance based on substantial equivalence to predicate devices. The "performance data" referred to in the document relates to mechanical testing of the components, not clinical performance or AI/ML algorithm performance.

    Therefore, I cannot fulfill the request as the provided text does not contain the required information for an AI/ML device.

    However, I can extract the information that is present regarding the device's technical performance relative to acceptance criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Criteria TypeAcceptance CriteriaReported Device Performance
    Mechanical TestingIn accordance with ASTM F1717 for static compression, static torsion, and dynamic compression.Worst case components of the modified implants were tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717 and compared with the original Range Spinal System components. The modified implants were determined to be substantially equivalent to the predicate devices.
    MaterialTo meet ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
    Design/SizingSubstantially the same as predicate devices.The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.

    Study Proving Device Meets Acceptance Criteria:

    The study conducted was a mechanical testing study comparing the modified components of the Range Spinal System to its predicate devices and original components.

    Information on requested AI/ML specific aspects (Not applicable to this device type based on the provided text):

    • Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical device components for mechanical testing. No patient data is mentioned for performance evaluation.
    • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on standardized tests and measurements, not expert consensus on clinical data.
    • Adjudication method for the test set: Not applicable.
    • 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.
    • If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
    • The type of ground truth used: For mechanical properties, the "ground truth" is derived from the physical properties of the materials and the results of the standardized ASTM F1717 tests.
    • The sample size for the training set: Not applicable.
    • How the ground truth for the training set was established: Not applicable.
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