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510(k) Data Aggregation

    K Number
    K153525
    Device Name
    Seneka II Polyscrew Pedicle Fixation System
    Manufacturer
    Senecka Spine
    Date Cleared
    2016-01-28

    (50 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K151849,K013444,K151216
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Seneka II Polyscrew Pedicle Fixation System may also be used for the same indications as an adjunct to fusion.

    Device Description

    The Seneka II Polyscrew Pedicle Fixation System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, reduction screws, domino connectors, offset connectors, hooks and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Seneka II system can be implanted via the open surgical approach.

    Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, cobalt chrome per ASTM F1537 or CP Titanium per ASTM E2371-13.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding the "Seneka II Polyscrew Pedicle Fixation System." It declares the device substantially equivalent to previously marketed predicate devices.

    However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical accuracy or effectiveness.

    The document discusses pre-clinical testing for mechanical properties, but this is distinct from clinical performance criteria for an AI/device's diagnostic or predictive accuracy. The "Performance Standards" section only mentions:

    • Pre-clinical testing performed includes static and dynamic compression bending, and static torsion per ASTM F1717-14.

    This is about the mechanical integrity of the pedicle fixation system components, not its diagnostic or clinical performance, nor does it involve any AI component.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance (in terms of clinical accuracy), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/diagnostic device. This document describes a surgical implant, not an AI or diagnostic medical device with performance metrics related to accuracy.

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