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510(k) Data Aggregation

    K Number
    K041409
    Manufacturer
    Date Cleared
    2004-08-20

    (85 days)

    Product Code
    Regulation Number
    882.1330
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Micro - recording and stimulation electrodes are intended to be used in the human brain for the recording of Neuro potentials of single brain cells and for electrical stimulation of small areas in the brain.

    Device Description

    MicroMacroelectrodes are equipped with a micro tip and a MacroElectrode. The micro tip is used to for recording cell potentials of single cells or of cell clusters and for If acca to tol sion. The macro tip is used for stimulation and recording of local field potentials.

    MacroElectrodes are monopolar electrodes equipped with an active macro tip. They are used for stimulation and recording of local field potentials.

    Micro Electrodes are monopolar electrodes equipped with a micro tip. They are used for recording cell potentials of single cells or cell clusters and for Microstimulation. They are similar to MicroMacroelectrodes but without the Macroelectrode.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called "Micro - recording and stimulation electrodes" by Inomed GmbH. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in documentation related to the validation of an AI/ML algorithm. This document is for a traditional medical device (electrodes) and focuses on regulatory submission for a hardware product.

    Therefore, I cannot extract the requested information from the provided text. The document is likely from 2004, predating the widespread use and regulatory considerations for AI/ML in medical devices.

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