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    K Number
    K173886
    Device Name
    CPRmeter 2 CPR Feedback Device
    Manufacturer
    Laerdal Medical AS
    Date Cleared
    2018-03-23

    (92 days)

    Product Code
    LIX
    Regulation Number
    870.5210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K151702
    Why did this record match?
    Device Name :

    CPRmeter 2 CPR Feedback Device

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

    The CPRmeter™ 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

    Device Description

    The CPRmeter™ 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter™ 2 is composed of polycarbonate. It is small, lightweight and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6"× 2 ½"× 1") and weighs approximately 163 g (5.7 oz), excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device.

    When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity. The CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.

    AI/ML Overview

    The CPRmeter™ 2 CPR Feedback Device's acceptance criteria and the study that proves it meets these criteria are detailed below. It is important to note that this device is not an AI-powered diagnostic tool, but rather a feedback device for CPR. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, training set details, expert ground truth for training) are not applicable.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the CPRmeter™ 2 are primarily based on its functionality in providing real-time feedback for CPR compressions according to current guidelines. The reported device performance is demonstrated through various verification and validation tests.

    FeatureAcceptance Criteria (Target)Reported Device Performance (Demonstrated)
    Depth Feedback> 50 mm and 50 mm and
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