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510(k) Data Aggregation

    K Number
    K063772
    Device Name
    EXPEDIUM SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2007-07-10

    (201 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K033901,K041119,K062174,K063156,K024348,K952236,K980485
    Predicate For
    K092473,K110551
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

    Device Description

    The subject EXPEDIUM™ Spine System rods are designed to work in conjunction with the components of the following DePuy Spine spine systems: EXPEDIUM™ 6.35mm Spine System (Ti + SS), EXPEDIUM™ 5.5mm Spine System (Ti + SS), ISOLA® 4.75mm Spine System (Ti + SS), ISOLA® 6.35mm Spine System (Ti + SS), MONARCH™ 5.5mm Spine System (Ti), MONARCH™ 6.35mm Spine System (Ti), MOSS MIAMI™ 5.0mm Spine System (SS), MOSS MIAMITM 5.5mm Spine System (Ti), MOSS MIAMI™ 6.35mm Spine System (SS), VIPERTM 5.5mm Spine System (Ti). Manufactured from ASTM F 138 implant grade stainless steel and ASTM F 136 implant grade titanium alloy.

    AI/ML Overview

    The provided document is a 510(k) summary for the EXPEDIUM™ Spine System, a medical device for spinal fixation. It describes the device, its intended use, materials, and a declaration of substantial equivalence to predicate devices, noting performance data per ASTM F 1717.

    However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically for diagnostic or AI-assisted devices.

    The product is a physical orthotic system, not a diagnostic device or an AI/software product that would typically have acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement. The "performance data" mentioned refers to mechanical testing (ASTM F 1717) for the physical components of the spinal system, not clinical or diagnostic performance criteria.

    Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text, as this information is not present. The questions about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information are all pertinent to the evaluation of AI or diagnostic devices, which this product is not.

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