(14 days)
The CPRmeter 2 CPR Feedback Device 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 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter 2 is composed of polycarbonate. It is small, lightweight, and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6.0" × 2.5" × 1.0") and weighs approximately 191 g (6.7 oz) excluding batteries. The device is 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 2 is intended for use by responders who have been trained in CPR and use of the CPRmeter 2. When placed on the bare chest of a suspected SCA victim, the CPRmeter 2 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 Silicone Cover is an optional accessory to the CPRmeter 2 that is designed to cover the patient contacting side of the CPRmeter 2 and provide a larger patient-contact area during use. The Silicone Cover does not require a patient adhesive.
The CPRmeter 2 CPR Feedback Device does not appear to be an AI/ML device per the provided text. Therefore, an analysis of the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The document describes a traditional medical device (CPR feedback device) and its accessory (a silicone cover) with comparisons primarily based on physical characteristics, materials, and existing functionalities, rather than algorithmic performance.
However, based on the provided text, I can extract the following information regarding the device and its testing:
Device Name: CPRmeter 2 CPR Feedback Device (with Silicone Cover accessory)
Indications for Use: To be used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for the CPRmeter 2 with the Silicone Cover based on its functional indications (e.g., accuracy of depth, rate, or release feedback). Instead, it focuses on verifying that the addition of the Silicone Cover does not negatively impact the existing performance and safety of the CPRmeter 2 device. The acceptance criteria are implied by the nature of the tests performed to demonstrate substantial equivalence, ensuring the accessory does not introduce new safety or effectiveness concerns.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | - Withstand changes in ambient pressure |
- Adequate physical fit
- Minimal water ingress
- Silicone Cover provides larger patient-contact area
- Textured surface stabilizes the device
- No new safety concerns compared to predicate | - Bench testing demonstrated acceptable performance for:
- Withstanding changes in ambient pressure
- Adequate physical fit
- Minimal water ingress
- The Silicone Cover functions as intended to provide a larger patient contact area and its textured surface stabilizes the device.
- The Silicone Cover does not raise any different questions regarding the safety or effectiveness of the CPRmeter 2. |
| Biocompatibility | - Materials of the device (specifically the new Silicone Cover) are biocompatible with patient contact. | - Biocompatibility analysis was performed and demonstrated biocompatibility of the materials of the device. |
| Shelf Life | - Device (with Silicone Cover) performs acceptably at the end of its labeled shelf life. | - Shelf life testing showed that the device could perform acceptably at the end of its labeled shelf life. |
| Functional Equivalence | - The addition of the Silicone Cover does not change the indications for use. - Fundamental scientific technology and principle of operation are unchanged. | - The Silicone Cover does not change the indications for use of the CPRmeter 2.
- The materials, fundamental scientific technology, and principle of operation of the CPRmeter 2 are unchanged with the addition of the Silicone Cover. |
| Adhesive Requirement | - When used with the Silicone Cover, a patient adhesive is not required. | - When the CPRmeter 2 is used with the Silicone Cover, the patient adhesive is not required. |
2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes in terms of patient data or specific CPR measurements. Instead, it refers to different types of engineering and materials testing:
- Bench testing: Performed to assess physical and mechanical aspects (pressure changes, fit, water ingress). No sample size or data provenance is provided.
- Shelf life testing: Conducted to evaluate performance over time. No specific sample size or provenance is provided.
- Biocompatibility analysis: Performed on the materials. No specific sample size or provenance is provided.
The testing seems to be laboratory-based (bench testing, shelf life, biocompatibility) rather than involving human subjects for performance evaluation in a clinical setting. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these engineering 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 provided in the document. The tests described are engineering and material science evaluations, which typically rely on established standards and laboratory procedures rather than expert consensus on clinical ground truth.
4. Adjudication method for the test set
Not applicable, as the tests performed are not clinical evaluations requiring adjudication.
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
Not applicable, as this is not an AI/ML device, and no MRMC study or human reader improvement data is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The CPRmeter 2 provides real-time feedback; it's a device for human-in-the-loop performance, not an algorithm performing autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in a clinical diagnostic or predictive sense is not directly applicable here. The "truth" for the tests performed (bench, shelf life, biocompatibility) would be defined by engineering specifications, material standards, and regulatory requirements.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML 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.