LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113514
    Device Name
    SMARTHEART
    Manufacturer
    SHL TELEMEDICINE INTERNATIONAL LTD.
    Date Cleared
    2012-02-22

    (86 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K080047
    Why did this record match?
    Device Name :

    SMARTHEART

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

    The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.

    Device Description

    The Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Smartheart device, extracted from the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text does not explicitly state quantitative acceptance criteria in a table format. However, it does outline the overall performance and equivalence claim.

    Acceptance Criteria (Implied)Reported Device Performance
    Safety and Effectiveness"clearly demonstrate that the Smartheart device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns."
    Effective 12-lead ECG transmitter"The results of the study clearly confirmed the efficacy of the Smartheart as a 12 lead ECG transmitter."
    Compliance with standardsTested according to IEC 60601-2-51:2005, IEC 60601-2-25 (1993) +A1:1999 (and others not fully listed).
    Substantial Equivalence to Predicate Device (CardioSenC™ K080047)"The Smartheart device has similar intended use and technological concepts as the market-cleared CardioSenC™."
    Digital signal transmission"The Smartheart is capable of transmitting the electrocardiographic signal digitally so it can be forwarded to a remote location as the market-cleared CardioSenC™."

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

    The text mentions a "usability study" but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

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

    The text mentions that the Smartheart is designed to enable review at a "physician's office, hospital or other medical receiving center" by a "certified medical professional capable of interpreting the results." However, it does not specify the number or qualifications of experts used to establish ground truth specifically for the usability study mentioned.

    4. Adjudication Method for the Test Set

    The provided text does not describe any adjudication method used for the test set in the usability study.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    The text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human readers with and without AI assistance is provided.

    6. Standalone (Algorithm Only) Performance Study

    The text describes the Smartheart as a device that transmits ECG signals for professional review. It does not describe a standalone (algorithm only) performance study or an AI component that would necessitate such a study. The device's function is data acquisition and transmission, not automated interpretation.

    7. Type of Ground Truth Used

    Based on the device's intended use to transmit ECGs for review by "certified medical professionals," the ground truth for evaluating the device's efficacy in data acquisition and transmission would likely be expert medical interpretation of the transmitted ECGs. However, the text does not explicitly state how ground truth was established for the usability study. Given the nature of the device, it would involve comparison of the transmitted ECGs to a reference standard (e.g., simultaneously acquired "gold standard" ECGs) and/or expert review of the quality and interpretability of the transmitted signals.

    8. Sample Size for the Training Set

    The provided text does not mention a training set or its sample size. This is consistent with the device being a data acquisition and transmission tool rather than an AI-powered diagnostic algorithm requiring a training phase for its core function.

    9. How Ground Truth for the Training Set Was Established

    As no training set is mentioned (since the device is a transmitter, not an AI interpreter), this information is not applicable and not provided in the text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1