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510(k) Data Aggregation

    K Number
    K200927
    Device Name
    Transept Cervical Plate System
    Manufacturer
    Neurostructures, Inc.
    Date Cleared
    2020-07-24

    (108 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K142060,K131374,K120515,K133518,K111796,K150666
    Why did this record match?
    Device Name :

    Transept Cervical Plate System

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

    The Transept™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

    Device Description

    The Transept™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transept™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transept™ Cervical Plate System implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (Transept™ Cervical Plate System), which is a spinal intervertebral body fixation orthosis.

    This type of device is a physical orthopedic implant and instrumentation, not an AI or software-as-a-medical-device (SaMD). The document details mechanical performance testing, materials, and indications for use, but does not contain information related to AI/ML device performance, acceptance criteria for an AI/ML algorithm, or details about clinical studies involving human readers or ground truth establishment for an AI/ML model.

    Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details, as these are not relevant to the described medical device and are not present in the provided text.

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