(69 days)
The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.
The Rhythm of Life by Rapid Response Solutions, LLC, is a pocket-sized metronome designed to assist both professional rescuers and trained lay rescuers in providing high quality cardiopulmonary resuscitation. This device is designed in accordance with the latest American Heart Association guidelines for CPR. The Rhythm of Life provides three distinctly different tones and visual feedback to prompt the rescuer to compress the patient's chest, ventilate the patient, and reassess the patient's condition every two minutes. The metronome will allow the rescuer to enter the type of patient that is being resuscitated along with other pertinent information, and then outputs proper resuscitation rates and ratios for that specific patient. Both professional and lay rescuers will benefit from additional guidance provided by the Rhythm of Life as it promotes adherence to the American Heart Association's guidelines and therefore improves the quality of patient care. The device is neither life supporting nor life sustaining.
The provided text is a 510(k) summary for the "Rhythm of Life" device, a CPR aid (metronome). It describes the device, its intended use, and indicates that testing was performed to demonstrate substantial equivalence to predicate devices and compliance with applicable standards. However, it does not include specific acceptance criteria or a detailed study report that proves the device meets those criteria in the way typically expected for a medical device's diagnostic or predictive performance.
The document focuses on regulatory compliance for device safety and effectiveness, primarily through demonstrating substantial equivalence to pre-existing devices and adherence to electrical safety and electromagnetic compatibility standards. It does not describe a study to assess the device's clinical performance in terms of improving CPR outcomes, diagnostic accuracy, or similar metrics.
Therefore, for many of your requested items, the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI C63.4 & 47 CFR Part 15, Subpart B (Electromagnetic Compatibility - Emissions) | Performed Testing |
| Compliance with EN60601-1-2 : 2001+A1:2006 (Medical Electrical Equipment - EMC Requirements) | Performed Testing |
| Compliance with CISPR 11 : 2003 (Industrial, Scientific and Medical RF Equipment - EMC Requirements) | Performed Testing |
| Compliance with IEC61000-4-2 : 1995+A1:1998+A2:2000 (Electrostatic Discharge Immunity) | Performed Testing |
| Compliance with IEC61000-4-3 : 2006 (Radiated RF Electromagnetic Field Immunity) | Performed Testing |
| Compliance with IEC61000-4-8 : 1993+A1:2000 (Power Frequency Magnetic Field Immunity) | Performed Testing |
| Substantial equivalence to predicate devices (CPR Ezy-Pad, Pocket-CPR, CPR Prompt, LyfeTymer) | Determined substantially equivalent by FDA |
| Meets all design specifications | Performed Testing (details not provided) |
Note: The document states that testing was "performed to demonstrate compliance" and that the device "is as safe, as effective, and performs as well to legally marketed predicate devices." However, it does not provide specific numerical results or performance metrics from these tests beyond the general statement of compliance. The focus is on regulatory and electrical standards, not clinical performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described appears to be engineering/regulatory compliance testing, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The device is a metronome, not a diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC or comparative effectiveness study of this nature was conducted. The device is a "CPR Aid (Metronome)" which provides visual and audio timing, not an AI-assisted diagnostic or interpretive tool where "human readers" would be involved in the sense of image or data interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" metronome; it doesn't involve an algorithm in the sense of AI or complex data processing that would typically be evaluated for standalone performance versus human-in-the-loop. Its primary function is timing and guidance, which is inherently "standalone" in its operation once activated. However, this is not "standalone performance" in the context of diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a metronome for CPR), the concept of "ground truth" for clinical performance in the typical diagnostic sense (e.g., against pathology) is not applicable or described. The "ground truth" for this device would relate to the accuracy of its timing signals against established AHA guidelines. The document does not detail how the accuracy of these timing signals was verified beyond stating that it "met all design specifications."
8. The sample size for the training set
This information is not provided and is not applicable for this type of device. The Rhythm of Life is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device.
§ 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.