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510(k) Data Aggregation

    K Number
    K023342
    Device Name
    NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
    Manufacturer
    HDC CORP.
    Date Cleared
    2004-03-02

    (512 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K883868,K882438,K992596,K955031
    Predicate For
    K061983,K072092,K093591,K102084
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the acceleromotive motor neuron, as a peripheral nerve stimulator (without the objective respecific first in a subjective monitoring and for locating specific nerves. It is measuring raneword 191 basyolock procedures to obtain effective regional anesthesia blocks.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain information regarding acceptance criteria or a study that proves the device (NeuroTrace III) meets specific performance criteria.

    This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

    Therefore, I cannot populate the requested table or answer the questions related to study design, sample sizes, ground truth establishment, or expert involvement. The information is simply not present in the provided text.

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