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    K Number
    K142586
    Device Name
    Captiva Spine FuselOX Cervical IBF System
    Manufacturer
    CAPTIVA SPINE
    Date Cleared
    2015-05-28

    (255 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K092794
    Why did this record match?
    Device Name :

    Captiva Spine FuselOX Cervical IBF System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. FuseLOX Cervical IBF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

    The Captiva Spine FuseLOX Cervical IBF is intended to provide mechanical support of the cervical spine while biologic fusion occurs. It is intended to be used with supplemental fixation.

    Device Description

    The Captiva Spine FuseLOX Cervical IBF System includes various size implants manufactured from implant grade PEEK-OPTIMA'™ LT1 conforming to ASTM F2026-12. The devices also have radiopaque markers made from either titanium alloy (Ti6Al4V) per ASTM F136 or tantalum per ASTM F560-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

    AI/ML Overview

    The provided text describes the Captiva Spine FuseLOX Cervical IBF System, a medical device for intervertebral body fusion. However, it does not include information about AI algorithms, acceptance criteria for AI performance, or any studies involving AI assistance or standalone AI performance.

    Therefore, I cannot answer your specific questions related to AI device performance, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, or how AI ground truth was established, as this information is not present in the provided document.

    The document discusses the regulatory submission for a physical medical device and its substantial equivalence to a predicate device based on mechanical testing. It does not pertain to the evaluation of an AI-powered diagnostic or assistive tool.

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