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The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.

The TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitations (CPR) in accordance with current guidelines.

This device is a CPR coaching device, meaning it provides real-time feedback on chest compressions. The provided text, however, focuses on administrative information related to the 510(k) submission and does not contain detailed information about the specific acceptance criteria or the study that demonstrates the device meets these criteria.

Therefore, for aspects related to precise performance metrics, sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies, the information is not available in the provided text. The text states that the 510(k) includes documentation related to verification and validation activities but does not elaborate on their specifics.

Based on the provided snippets, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text. The submission mentions "Performance Standards" and "verification and validation activities supporting the safe and effective use of TrueCPR," but it does not detail specific quantitative acceptance criteria or the device's reported performance against them (e.g., accuracy of depth measurement, rate measurement, etc.).

2. Sample size used for the test set and the data provenance

This information is not available in the provided text. The document refers to "Bench Testing (Comprehensive verification testing)" and "Simulated Use Testing" but does not specify the sample sizes or data provenance for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided text.

4. Adjudication method for the test set

This information is not available in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is a "coaching device" to assist rescuers, not an AI-assisted diagnostic tool that would typically involve "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here in the typical sense of interpreting medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is explicitly a "coaching device" intended to "provide feedback to assist rescuers," which inherently implies a human-in-the-loop scenario. The text does not describe any standalone algorithm-only performance testing in the context of interpretation or diagnosis. However, "bench testing" and "simulated use testing" would likely involve evaluating the device's ability to accurately measure and provide feedback on CPR parameters independently, but these are not referred to as a "standalone algorithm performance" in the context of diagnosis.

7. The type of ground truth used

The text does not explicitly state the type of ground truth used for specific performance evaluations. For a CPR coaching device, ground truth would typically refer to accurate measurements of compression depth, rate, recoil, etc., obtained through high-precision sensors or standardized testing apparatus in a laboratory or simulated environment, rather than expert consensus, pathology, or outcomes data, which are more common for diagnostic devices.

8. The sample size for the training set

This information is not available in the provided text.

9. How the ground truth for the training set was established

This information is not available in the provided text.

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