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510(k) Data Aggregation

    K Number
    K974010
    Device Name
    ADVANTAGE EMG SYSTEM, MODEL #A100
    Manufacturer
    ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
    Date Cleared
    1998-01-16

    (87 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K885246
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.

    Device Description

    The technological characteristics remain unchanged as a result of the modification to the device. Using surface electrodes, signals are recorded from the surface of the skin, or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed. The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture. The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry.

    AI/ML Overview

    This 510(k) summary (K974010) is for a modification to an existing device, the Advantage EMG System, Model #A100. The submission focuses on demonstrating that a corrective modification (removal of diodes) did not adversely affect the device's safety or effectiveness, rather than establishing initial performance criteria or conducting studies for a new device. Therefore, much of the requested information about acceptance criteria for device performance, specific study designs (like MRMC or standalone performance), and ground truth establishment (as typically applied to diagnostic algorithm performance) is not directly present in this document.

    Here's a breakdown of the available information based on your request:

    1. A table of acceptance criteria and the reported device performance

    This document does not outline specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for the diagnostic function of the EMG system, nor does it report such metrics. The "performance" described relates to the safety and effectiveness after a modification.

    Acceptance Criteria (Implied)Reported Device Performance
    Corrective action is effective (to a prior identified issue).Confirmed through failure investigation, ESD, and actual use testing.
    Modification does not adversely affect safety of the product.Confirmed through failure investigation, ESD, and actual use testing.
    Modification does not adversely affect effectiveness of the product.Confirmed through failure investigation, ESD, and actual use testing.
    Remains substantially equivalent to the predicate device.FDA determined the device is substantially equivalent (K974010).

    2. Sample size used for the test set and the data provenance

    The document does not specify a distinct "test set" in the context of evaluating diagnostic performance. The testing described was to support the effectiveness of a corrective modification.

    • Sample Size: Not specified for any particular test set. The document mentions "actual use testing" but no details on the number of subjects or tests.
    • Data Provenance: Not explicitly stated. Given the submitter's address is in Canada, it's possible testing data originated there, but this is not confirmed. The testing was conducted to support the effectiveness of a corrective action.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This information is not applicable and not provided in the document. The study was not designed to establish "ground truth" for diagnostic performance in the way a new diagnostic algorithm would be evaluated. It was focused on the impact of a hardware modification.

    4. Adjudication method for the test set

    Not applicable and not provided.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No, an MRMC comparative effectiveness study was not done. This device is an EMG system, not an AI-powered diagnostic tool, and the submission concerns a hardware modification.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This is not an algorithmic device in the context of AI. The performance evaluation relates to the physical device's function after a modification.

    7. The type of ground truth used

    Not applicable in the conventional sense of diagnostic algorithm evaluation. The "truth" being established was that the corrective action worked and did not negatively impact the device's operation. This was verified through:

    • Failure investigation: Likely involved analysis of the original failure mode.
    • Electrostatic Discharge (ESD) testing: Verifying the device's resilience to static electricity.
    • Actual use testing: Implies functional validation under practical conditions.

    8. The sample size for the training set

    Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

    9. How the ground truth for the training set was established

    Not applicable.

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