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510(k) Data Aggregation

    K Number
    K210036
    Device Name
    Carnation Ambulatory Monitor (CAM)
    Manufacturer
    Bardy Diagnostics, Inc.
    Date Cleared
    2021-02-05

    (30 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for the Carnation Ambulatory Monitor (CAM). The document is a 510(k) clearance letter from the FDA, which confirms the device's substantial equivalence to a predicate device and provides general regulatory information and the Indications for Use.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test or training sets, nor data provenance.
    3. Information about experts, ground truth establishment for the test set, or adjudication methods.
    4. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
    5. The type of ground truth used (e.g., pathology, outcomes data).

    Therefore, based solely on the provided text, it's not possible to answer the detailed questions regarding acceptance criteria and the study proving device performance.

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