(102 days)
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:
- 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.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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.
- Standalone (algorithm-only) performance: Not mentioned.
- 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).
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 870.5210 Cardiopulmonary resuscitation (CPR) aid.
(a)
CPR aid without feedback —(1)Identification. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
CPR aid with feedback —(1)Identification. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use.
(ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant).(iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iv) For devices containing software, software verification, validation, and hazard analysis must be performed.
(v) Components of the device that come into human contact must be demonstrated to be biocompatible.
(vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user.
(3)
Premarket notification. The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (e.g., is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in § 870.9.