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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.

• 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.

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