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

The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - 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. The CPRmeter™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 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.

This document describes the FDA 510(k) summary for the CPRmeter™ CPR Feedback Device with a Modified Cover. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (CPRmeter™ with Predicate Cover) by showing that the new Modified Cover does not raise new questions of safety or effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table for each criterion. Instead, it states that "The following tests demonstrate that the Modified Cover met applicable design and performance requirements and support a determination of substantial equivalence." and mentions general outcomes.

Implied Acceptance Criteria & Reported Performance (Based on the text):

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

The document does not specify a sample size for any test set in terms of patient data or a specific number of units tested.
The "Data Used in Determination of Substantial Equivalence" section refers to "Bench testing," "Shelf life testing," and "Biocompatibility analysis." These are likely laboratory or in-vitro tests, not clinical studies with patient data.

• Sample Size: Not specified (refers to bench testing, not human subjects).
• Data Provenance: Not explicitly stated as retrospective or prospective human data. The tests described (bench, shelf life, biocompatibility) are typically performed in a laboratory setting. The device manufacturer, Laerdal Medical AS, is based in Norway.

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

This information is not provided in the document as the tests described are bench tests and material analyses, not studies requiring expert clinical judgment for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are bench tests and material analyses, not studies involving human interpretation or adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The submission focuses on substantial equivalence of a modified accessory (the cover) through bench testing, not clinical effectiveness studies comparing human reader performance.

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

The CPRmeter™ is a physical device that provides real-time feedback during CPR. Its function relies on sensors (accelerometer and force sensor) and internal processing to provide visual feedback to a human rescuer. Therefore, the concept of a "standalone algorithm" acting without human-in-the-loop performance is not directly applicable in the typical sense of AI-driven diagnostic tools.

However, the "bench testing" and "shelf life testing" could be considered as evaluating the device's intrinsic performance (its 'algorithm' for sensing and displaying data) independent of a human rescuer, under controlled, simulated conditions. The document states these tests demonstrated "acceptable performance," implying the device's sensing and feedback mechanism functions correctly.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be known physical parameters (e.g., precisely controlled compression depths, rates, and release) against which the device's reported measurements are compared. For biocompatibility, the ground truth is established by biocompatibility standards and test protocols.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The document describes a 510(k) submission for a physical device with a modified cover, not an AI/ML device that typically requires a training set. The device's functionality is based on established biomechanical principles and sensor technology, not machine learning trained on large datasets.

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

This information is not applicable/not provided as there is no mention of a training set for an AI/ML algorithm.

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