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510(k) Data Aggregation

    K Number
    K182544
    Device Name
    AccelFix Spinal Fixation System
    Manufacturer
    L&K BioMed Co., Ltd.
    Date Cleared
    2019-05-28

    (253 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K171813,K974749,K000236,K011437,K172546,K091725,K031585,K053573,K161766
    Predicate For
    K200789,K200794,K223565,K230245,K231636,K232311
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

    Device Description

    AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The components of this system are manufactured of Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) or CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The AccelFix Spinal Fixation System is comprised of five different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, and Accessory.

    AI/ML Overview

    The provided text is a 510(k) summary for the "AccelFix Spinal Fixation System," a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through mechanical and material performance testing, not through clinical or AI-driven diagnostic accuracy studies.

    Therefore, the information required to answer your prompt about AI device acceptance criteria, study design, expert ground truth, etc., is not present in this document. This typically applies to devices like AI-powered diagnostic software, not spinal implants.

    The document describes:

    1. Device Type: A spinal fixation system (pedicle screws, rods, etc.).
    2. Indications for Use: Stabilization of spinal segments, fixation for various spinal conditions.
    3. Materials: Titanium Alloy and CoCrMo alloy.
    4. Performance Data: Lists ASTM standards for various mechanical tests (static compression, torsion, fatigue, cantilever, pullout, axial grip force).
    5. Conclusion: The device is substantially equivalent to predicates based on similar design, materials, performance characteristics, and intended use.

    In summary, this document does not contain any information about:

    • Acceptance criteria for an AI-driven or diagnostic device.
    • "Reported device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).
    • Sample sizes for AI test sets.
    • Data provenance for clinical imagery.
    • Number/qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC studies or human reader improvement with AI.
    • Standalone algorithm performance.
    • Types of ground truth (beyond mechanical testing per ASTM standards).
    • Training set details for an AI model.

    The "study" mentioned refers to engineering and biocompatibility testing required for a mechanical orthopedic implant, not a clinical trial for an AI diagnostic tool.

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