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510(k) Data Aggregation

    K Number
    K183054
    Device Name
    SYNMESH System
    Manufacturer
    DePuy Synthes Spine
    Date Cleared
    2019-05-23

    (202 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K003275
    Why did this record match?
    Device Name :

    SYNMESH System

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

    The SYNMESH™ Spacer is a vertebral body replacement device in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SYNMESH Spacer is intended to be used with Synthes supplemental internal fixation of the SYNMESH Spacer can be packed with bone graft.

    The SYNMESH™ System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

    Device Description

    The SYNMESH System spacer is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy/vertebrectomy. Different cross section sizes and heights are available to suit the individual pathology and anatomical conditions.

    The SYNMESH System spacer consists of a cylindrical round or oblong mesh, end rings, standard rings and screws. The round mesh is used in pairs and is available in various diameters and heights. The oblong mesh is used individually and is also available in various cross-section sizes and heights.

    AI/ML Overview

    The provided text is a 510(k) summary from the FDA for a medical device called the "SYNMESH™ System." It describes the device, its intended use, and claims substantial equivalence to a predicate device based on material and non-clinical performance testing.

    However, the document DOES NOT contain information regarding the acceptance criteria or study details for an AI/algorithm-driven device.

    Specifically, the device described is a spinal implant (vertebral body replacement device), which is a physical product, not a software or AI-driven diagnostic/treatment tool. As such, the concept of "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC) and studies involving expert readers, ground truth establishment, training/test sets, or MRMC studies are not applicable to this particular 510(k) submission.

    The "performance data" mentioned (static/dynamic torsion, compression, expulsion, subsidence) refers to mechanical testing of the physical implant, not the performance of an AI algorithm.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving an AI device meets them, as the provided document describes a physical medical implant.

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