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510(k) Data Aggregation

    K Number
    K190584
    Device Name
    CAYMAN LP Plate System
    Manufacturer
    K2m, Inc.
    Date Cleared
    2019-05-15

    (70 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K080302,K181063,K142699
    Why did this record match?
    Device Name :

    CAYMAN LP Plate System

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

    The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

    Device Description

    The CAYMAN LP Plate System are non-load bearing devices, each consisting of a plate and screw for attachment to the vertebral body. The plates are designed to be used as additions to spinal fusion procedures from the lateral and anterior approaches, forming a preventative barrier to intervertebral cage movement. Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in a spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

    AI/ML Overview

    The provided text describes the CAYMAN LP Plate System, a spinal implant, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing. No information is provided in the document regarding acceptance criteria for an AI/ML device, nor any study proving an AI/ML device meets such criteria.

    The document describes a medical device, the CAYMAN LP Plate System, which is a physical implant used in spinal fusion procedures. It is not an AI/ML device, and thus, the concepts of a "test set," "training set," "ground truth," "human readers," or "AI assistance" do not apply to the information presented.

    Therefore, I cannot provide a table of acceptance criteria, details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

    The study described in the document is a nonclinical mechanical test to demonstrate the ability of the physical plates to resist migration or expulsion of graft material, and to show mechanical superiority to a legacy predicate device. This is a performance test for a physical medical device.

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