Search Results

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 CPRmeter™ device is small, lightweight (approximately the size and weight of a cell phone), and powered by a replaceable battery. The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. If in doubt about the appropriateness for use or ability to use. CPR is to be performed without using the CPRmeter device.

When attached to the bare chest of a suspected SCA victim, the CPRmeter device 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 provided text focuses on the device description, indications for use, predicate devices, and general testing criteria for substantial equivalence of the CPRmeter™ CPR Feedback Device. However, it does not contain specific acceptance criteria or detailed study information in the format required for the requested output.

Specifically, the document mentions:

• "Design verification and design validation testing demonstrates that the CPRmeter device meets its functional requirements and performance specifications."
• "Compression depth detection and accuracy have been verified under a wide variety of use or pre-use conditions (e.g., drop testing, temperature and humidity stress, after repeated cleaning)."

But it does not provide:

• A table of specific acceptance criteria (e.g., "accuracy > 90% for depth measurement") and reported performance values.
• Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
• Information about MRMC studies, standalone algorithm performance, or how ground truth was established for training/test sets.

Therefore,Based on the provided text, I cannot complete the requested information, which requires specific acceptance criteria and detailed study parameters. The document states that the device's "functional requirements and performance specifications" and "compression depth detection and accuracy have been verified," but it does not specify what those requirements or accuracy thresholds are, nor does it describe the studies (e.g., sample sizes, ground truth methods, expert involvement) used to verify them.

Missing Information:

1. Table of acceptance criteria and reported device performance: The document only states that the device "meets its functional requirements and performance specifications" and that "compression depth detection and accuracy have been verified." It does not provide specific numerical criteria or reported performance values.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not mentioned. The device is a feedback device for CPR, not an AI diagnostic tool, so an MRMC study in the typical sense wouldn't apply here.
6. Standalone (algorithm-only) performance: Not mentioned.
7. Type of ground truth used: Not explicitly stated how "compression depth detection and accuracy" were verified, so the type of ground truth is unclear (e.g., mechanical test rig, expert measurement).
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Ask a specific question about this device