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510(k) Data Aggregation

    K Number
    K170677
    Device Name
    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
    Manufacturer
    Neurovision Medical Product Inc.
    Date Cleared
    2017-04-05

    (30 days)

    Product Code
    GWF,ETN
    Regulation Number
    882.1870
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurovision Medical Product Inc.

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

    The Neurovision Nerve LocatorMonitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surgical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.

    The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

    Device Description

    The Neurovision Nerve LocatorMonitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability.

    The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria, study details, and performance of the Neurovision Nerve Locator Monitor (Nerveana) and EMGView Software. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device and states the indications for use. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or details about training sets.
    • Information on ground truth establishment, expert qualifications, or adjudication methods.
    • Details about MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot generate the requested table and paragraphs based on the provided input.

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