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510(k) Data Aggregation

    K Number
    K181998
    Device Name
    CardioBand ECG Event Recorder
    Manufacturer
    Samsung Strategy and Innovation Center (SSIC)
    Date Cleared
    2018-11-15

    (112 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K171816
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CardioBand Event Recorder is indicated for use by adult patients, when prescribed by a physician, to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation.

    Device Description

    The CardioBand Event Recorder is intended to be used by a single patient to record, display, store and transfer single-channel electrocardiogram (ECG) for rhythm interpretation. The system consists of three components: a wrist-worn CardioBand, a smart-phone application, and a secure cloud. The CardioBand records ECG signals from the patient and sends them to the smart-phone application. The smart-phone application then sends the data to the cloud, where it can be accessed by qualified healthcare providers.

    AI/ML Overview

    The CardioBand Event Recorder underwent clinical testing to validate the signal quality of its ECG signal.

    1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the text. The document states that the CardioBand demonstrated substantial equivalence to the predicate device in quantitative ECG measurement analysis when compared to a gel-electrode reference ECG device given a margin of clinically acceptable measurement error. However, the specific acceptance criteria and the reported performance values are not detailed.

    2. Sample Size used for the test set and data provenance:

      • Sample Size: Not explicitly stated.
      • Data Provenance: The study was a "single-center" study. The country of origin is not specified, but the applicant's address is in San Jose, California, USA. The study was "non-randomized," and it is implied to be prospective as it's a validation study.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.

    4. Adjudication method for the test set: Not explicitly stated.

    5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a "comparative" study of signal quality comparing the CardioBand to a predicate device and a reference device. It does not mention human readers or and AI assistance.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided text focuses on the device's signal quality and comparison to other ECG devices. It does not mention a specific algorithm for interpretation or its standalone performance in isolation from the hardware. The device is intended for "rhythm interpretation," implying either human interpretation from the displayed ECG or a subsequent algorithmic analysis (which is not detailed here).

    7. The type of ground truth used: The ground truth for the test set was established by a "reference gel-electrode 12-lead ECG device."

    8. The sample size for the training set: Not applicable, as this study describes a validation of signal quality, not the training of an AI algorithm.

    9. How the ground truth for the training set was established: Not applicable.

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