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    K Number
    K092011
    Device Name
    NORM SPINAL SYSTEM
    Manufacturer
    NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR
    Date Cleared
    2009-10-28

    (114 days)

    Product Code
    MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K063708,K031585
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORM TIBBI URUNLER ITHALAT IHRACAT SANAYI VE TICAR

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

    NORM spinal system implants are designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications of the thoracic, lumbar and sacral spine:

    • degenerative spondylolisthesis with objective evidence of neurological impairment;
    • fracture;
    • dislocation;
    • scoliosis;
    • kyphosis;
    • spinal tumor; and failed previous fusion (pseudarthrosis).
      Levels of fixation are for the thoracic, lumbar and sacral spine.
      Norm Posterior Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attachment of a solid fusion.
    Device Description

    Norm Spinal System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods and set screw. The Norm Spinal System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Norm Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these components are available.

    AI/ML Overview

    The Norm Spinal System aims to provide immobilization and stabilization of spinal segments. The system's performance was evaluated through non-clinical testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Meet Static Compressive requirements per ASTM F 1798-97Tests conducted, results show equivalence or superiority to predicate devices.
    Meet Static Torsion requirements per ASTM F 543-02Tests conducted, results show equivalence or superiority to predicate devices.
    Meet Dynamic Compressive requirements per ASTM F 2193-02Tests conducted, results show equivalence or superiority to predicate devices.
    Meet Dynamic Compressive requirements per ASTM F 1717-04Tests conducted, results show equivalence or superiority to predicate devices.

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

    The document does not explicitly state the sample size for the test set (number of devices/components tested). The tests conducted are non-clinical (mechanical) and not patient-based. Thus, there is no country of origin for human data, and the data is retrospective in the sense that it relies on standardized mechanical testing protocols rather than clinical trials.

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

    Not applicable. This device's performance is demonstrated through mechanical engineering tests against ASTM standards, not expert interpretations of clinical data for ground truth.

    4. Adjudication Method for the Test Set

    Not applicable. Performance is determined by meeting mechanical test specifications, not through expert adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This is a spinal fixation system, not an AI-assisted diagnostic or imaging device. The study focused on mechanical performance, not human reader improvement with AI.

    6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

    Not applicable. This device is a physical implant, not an algorithm. Its standalone performance is inherently its mechanical performance.

    7. Type of Ground Truth Used

    The ground truth used for evaluating the device is established by:

    • ASTM Standards: The mechanical tests (static compressive, static torsion, dynamic compressive) are performed according to recognized industry standards (ASTM F 1798-97, ASTM F 543-02, ASTM F 2193-02, ASTM F 1717-04). These standards define the acceptable performance parameters.
    • Predicate Device Performance: The primary comparative measure for "ground truth" in this 510(k) submission is the performance of legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). The Norm Spinal System is considered to meet the acceptance criteria if it performs "as well as or better than" these predicate devices.

    8. Sample Size for the Training Set

    Not applicable. The device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be its design and manufacturing process, optimized through engineering principles.

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

    Not applicable, as there is no training set in the context of an AI/ML algorithm. The design and manufacturing processes of the device would be based on engineering principles and material science, aiming to meet the performance requirements of ASTM standards and match or exceed predicate device performance.

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