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    K Number
    K953762
    Device Name
    HEART 400 ECG TRANSMITTER
    Manufacturer
    AEROTEL, LTD.
    Date Cleared
    1996-07-18

    (342 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K930314,K931020
    Why did this record match?
    Device Name :

    HEART 400 ECG TRANSMITTER

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

    The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone.

    Device Description

    The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The Heart 400 transmits each of leads I, II, III as selected by the patient. Patient connection is done by means of electrodes and a patient cable. The electrodes are attached by the physician. To transmit the electrocardiogram, the telephone handset transmitter is placed over the device and the On/Off button of the H400 is released. At the receiving center, the ECG will be edited and recorded.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Aerotel Heart 400 ECG Transmitter's acceptance criteria and studies:

    Based on the provided text, the device is extremely simple, and the "study" is equally simple. It involves a comparison of ECG signal quality transmitted by the new device vs. the predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Non-clinical Tests:
    Common mode rejectionPassed (implied "no safety question")
    Frequency responsePassed (implied "no safety question")
    Sound level of the audio signalPassed (implied "no safety question")
    Temperature stressPassed (implied "no safety question")
    Ratio (unspecified type of ratio)Passed (implied "no safety question")
    Electromagnetic immunityPassed (implied "no safety question")
    Shock and vibrationPassed (implied "no safety question")
    Clinical Tests:
    Equivalence in quality of transmitted ECGs to predicate device (Heart 1001)"The quality of the electrocardiograms in every case is equivalent."
    Equivalence in safety and efficacy to predicate device"The Heart 400 is equivalent in safety and efficacy to its predicate device."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Three volunteers.
    • Data Provenance: Not explicitly stated, but given it's a 1996 submission from Aerotel Ltd. in Israel, the volunteers likely originated from Israel. The study appears to be prospective as it involves "volunteers" specifically undergoing testing for this submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    The document does not specify the number or qualifications of experts used to establish the ground truth. It simply states that "The quality of the electrocardiograms in every case is equivalent," implying an internal assessment, but without detailing who performed this assessment.

    4. Adjudication Method for the Test Set

    The document does not describe any specific adjudication method. The assessment of "equivalent quality" appears to be a direct conclusion from comparing the transmitted ECGs.

    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 conducted. This device is a simple ECG transmitter, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not applicable here.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This is not applicable to the Heart 400. The device itself is a signal transmitter, and its "performance" is assessed by the quality of the transmitted signal, not by an algorithm's diagnostic capabilities. The study assesses the device's ability to transmit an ECG, which would then be interpreted by a human at a receiving center.

    7. The Type of Ground Truth Used

    The ground truth for the clinical test was the quality of the electrocardiograms taken from the volunteers using both the Heart 400 and the predicate device (Heart 1001). The "ground truth" was essentially the visual and expert assessment of whether the transmitted ECGs were of comparable quality. This is an implied "expert consensus" on signal quality, though the experts are not quantified or qualified.

    8. The Sample Size for the Training Set

    There is no mention of a "training set" for this device. This is not an AI/ML device that requires training data. The "study" described is purely for performance testing and comparison to a predicate.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this device.

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