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510(k) Data Aggregation

    K Number
    K200794
    Device Name
    AccelFix Spinal Fixation System
    Manufacturer
    L&K BIOMED Co., Ltd.
    Date Cleared
    2020-10-20

    (208 days)

    Product Code
    NKB,KWP,KWQ
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K182544
    Predicate For
    K230245,K231636,K232311
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: 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, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)

    Device Description

    The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The AccelFix Spinal Fixation System is comprised of six different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, AccelFix -SAI Screw, and Accessory.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the AccelFix Spinal Fixation System. This document focuses on the substantial equivalence of and mechanical testing for a medical device (spinal fixation system), not an AI/ML-driven diagnostic or image analysis device.

    Therefore, the information required to answer your query about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.

    The document states that the additional components for the AccelFix Spinal Fixation System "do not require additional mechanical testing" because none of the additional components is the worst case, and they are substituting mechanical test data from the predicate device (K182544). It cites compliance with ASTM standards for mechanical testing (ASTM F17-15, ASTM F1798-13, ASTM F543-17).

    To summarize, for an AI/ML device, your requested information would typically include details on diagnostic performance, reader studies, and dataset characteristics. This document, however, pertains to the mechanical and material equivalence of an implantable medical device.

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