LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981951
    Device Name
    CT 100 ELECTROCARDIOGRAPH
    Manufacturer
    MACQUARIE MEDICAL SYSTEMS
    Date Cleared
    1998-07-28

    (90 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K946205,K904032
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display of the electrical signal produced by the heart.

    Device Description

    The device is a battery-operated, portable, 12 lead electrocardiograph which produces a single channel strip chart output.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Macquarie CT 100 Electrocardiograph. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    The document primarily focuses on:

    • Manufacturer and Contact Information: Macquarie Medical Systems.
    • Device Classification and Names: Electrocardiograph, CT 100 Electrocardiograph.
    • Substantial Equivalence: To Schiller Cardiovit AT-1 (K946205) and Burdick Elite II (K904032).
    • Device Description: Battery-operated, portable, 12-lead electrocardiograph producing a single-channel strip chart output.
    • Intended Use: Diagnostic device to retrieve, record, and visually display the heart's electrical signal.
    • Technological Characteristics: Similar to other standard one-channel printout electrocardiographs.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are present.
    2. Sample sized used for the test set and the data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
    4. Adjudication method: Not mentioned.
    5. MRMC comparative effectiveness study: Not mentioned.
    6. Standalone performance study: Not mentioned.
    7. Type of ground truth used: Not mentioned.
    8. Sample size for the training set: Not mentioned.
    9. How the ground truth for the training set was established: Not mentioned.

    This document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a clinical or performance study report that would detail the information you are seeking.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1