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510(k) Data Aggregation

    K Number
    K162873
    Device Name
    MEP Monitor
    Manufacturer
    TONICA ELEKTRONIK A/S
    Date Cleared
    2017-03-31

    (169 days)

    Product Code
    GWF
    Regulation Number
    882.1870
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K061645,K091940,K051864
    Why did this record match?
    Device Name :

    MEP Monitor

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

    The MEP Monitor is an accessory for the MagPro stimulators (MagPro R30, MagPro R30 including MagOption, MagPro X100, and MagPro X100 including MagOption) and is intended to monitor evoked potentials.

    Device Description

    The MEP Monitor is a small accessory device which is connected to the rear side of a MagPro magnetic stimulator. The MagPro magnetic stimulators are FDA cleared in K061645 and K091940. The device in this submission is not used alone but is connected to the MagPro stimulators on the rear side of either of the 4 cleared stimulators. The setup of the MEP Monitor is done in the MEP menu on the stimulator. The display on the stimulator shows a curve with the MEP response. The Motor Evoked Potential (MEP) Monitor is an optional component which allows the user to capture EMG signals and display them on the MagPro UI. Device with 1 channel input. Isolated input DIN-connector (Body Floating). Directly connected to the rear panel of the magnetic stimulator device. The MEP Monitor is designed to be used with surface electrodes only. Supports connections of standard electrode cables and surface electrodes.

    AI/ML Overview

    The provided text is a 510(k) summary for the MEP Monitor, a medical device accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria through clinical or algorithmic testing.

    Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in an AI/algorithm context, a specific study proving it meets those criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.

    This is a regulatory submission based on substantial equivalence, which means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, rather than providing novel performance data against predefined acceptance criteria from a new study. The "Testing" section primarily refers to compliance with electrical safety and EMC standards, not clinical performance metrics for an AI/algorithm.

    In summary, none of the requested information about acceptance criteria, study details, sample sizes, expert involvement, or AI-specific performance metrics is present in the provided text.

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