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510(k) Data Aggregation

    K Number
    K072426

    Validate with FDA (Live)

    Device Name
    ATLAS SPINE PEDICLE SCREW SYSTEM
    Manufacturer
    ATLAS SPINE LLC
    Date Cleared
    2007-10-19

    (51 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K010515,K010742,K984251,K060979
    Predicate For
    K110842,K112759
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.

    Device Description

    The Atlas Spine Pedicle Screw System is a titanium alloy (6Al-4V ELI per ASTM F136) device consisting of a variety of non-sterile, single use components. The system consists of an assortment of polyaxial and monoaxial screws, cross connectors, rods, collar assemblies, offset receptacle bases and straight receptacle bases.

    AI/ML Overview

    The provided document is a 510(k) summary for the Atlas Spine Pedicle Screw System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes, ground truth establishment, or expert involvement for AI/device performance assessment.

    The "Performance Data" section merely states: "Data were submitted to characterize the Atlas Spine Pedicle Screw System." without providing any details of what that data was or what it showed. This suggests the data primarily related to mechanical testing to ensure the device met engineering standards rather than clinical performance based on a study with a test set, ground truth, or human-in-the-loop assessments as typically found for AI/imaging devices.

    Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or details on training/test sets and ground truth. This type of information is not present in the provided 510(k) summary.

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