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510(k) Data Aggregation

    K Number
    K142185
    Device Name
    EXPEDIUM VERSE SPINE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2014-11-19

    (103 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K091994,K124004,K111136,K033901,K070387
    Predicate For
    K143683,K191212,K200245,K200267
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EXPEDIUM Verse System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine.

    The EXPEDIUM Verse 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

    When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse 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.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The EXPEDIUM® Verse System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. Verse is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM Verse is a self-contained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the DePuy Synthes Spine EXPEDIUM® Verse Spine System. It describes the device, its intended use, and comparability to predicate devices, but does not contain information related to software or AI algorithms, nor does it provide a study that directly assesses the performance of an AI device against specific acceptance criteria.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for AI-related studies.

    The document discusses mechanical testing for the physical medical device (spinal implant system), not an AI or software device. The "Non-clinical Test Summary" and "Conclusion" sections refer to these mechanical tests.

    To answer your request, I would need a document detailing the performance of an AI-based device, including its acceptance criteria and a study demonstrating its performance.

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