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    K Number
    K051448
    Device Name
    MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
    Manufacturer
    MEDOC LTD. ADVANCED MEDICAL SYSTEMS
    Date Cleared
    2005-06-29

    (27 days)

    Product Code
    NTU
    Regulation Number
    882.1870
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K041908
    Why did this record match?
    Device Name :

    MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)

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

    The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations in evaluating the functionality of human pain reception and transmission of sensory pathways.

    Device Description

    The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "Modified Contact Heat-Evoked Potential Stimulator (CHEPS)". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics for the device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies against specific criteria.

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