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510(k) Data Aggregation

    K Number
    K151849
    Device Name
    Seneka I Polyscrew Pedicle Fixation System
    Manufacturer
    Senecka Spine
    Date Cleared
    2015-09-30

    (85 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022623,K031585,K001319
    Predicate For
    K153525
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Seneka I Polyscrew Pedicle Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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 Seneka I 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 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 I 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

    The provided text is a 510(k) summary for a medical device (Seneka I Polyscrew Pedicle Fixation System). It focuses on demonstrating substantial equivalence to predicate devices, primarily through material and mechanical performance testing, rather than clinical efficacy through human-centric studies with acceptance criteria for algorithm performance.

    Therefore, the information required to answer the prompt directly, such as acceptance criteria for device performance in terms of diagnostic accuracy/sensitivity/specificity, a multi-reader multi-case study, or standalone algorithm performance, is not present in the document.

    The document mainly covers:

    1. Device Description and Indications for Use: The system is for posterior, non-cervical pedicle fixation as an adjunct to fusion for various spinal conditions.
    2. Predicate Devices: Moss Miami System (DePuy Spine) (K022623), Optima System (U&I) (K031585), and Xia Spinal System (Stryker) (K001319).
    3. Performance Standards/Testing: Pre-clinical testing included static and dynamic compression bending, and static torsion per ASTM F1717-10. These are mechanical tests for the physical device, not related to diagnostic or AI performance.
    4. Technological Characteristics: Comparison to predicate devices regarding indications for use, materials, function, sizes, and mechanical test results.

    In summary, this document does not contain the type of information requested about acceptance criteria for AI/algorithm performance, multi-reader studies, or ground truth establishment relevant to an AI-powered device. It is a regulatory submission for a physical implantable device.

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