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RespAide™ is designed to be used in an emergency situation where CPR assistance is required. RespAide™ offers to the administrator of CPR the comfort that the risk of transmission of various pathogens is greatly reduced and, therefore, the hesitancy factor for providing CPR is overcome. RespAide™ should be made available to all consumers for office, automobiles, boats, swimming pools, industry, airlines, and anywhere an incident of respiratory or cardiac arrest may occur.

Non Re-Breathing Valve, 73 CBP, Class II under CFR 868.5870 Respiratory assisted device - used in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR).

Emergency Filtration Products, Inc. wishes to introduce to the market the RespAide™ air filtering CPR assistance mask, a device similar to the Laerdal pocket mask. Both products are one way valve, CPR assistance masks.

RespAide™ features include the following:

• One Way Valve with Hydrophobic and Hydrophilic Filters .
• Pillow Mask
• ISO Fittings
• Nylon Stuff Sack .
• Mouthpiece .
• Latex Gloves ●
• Antiseptic Wipe ●
• Biohazard Bag for disposal after use

The provided document is a 510(k) summary for the RespAide™ Valve for CPR Assistance. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Based on the document, here's an analysis of the acceptance criteria and study information:

Description of the Study:

The study conducted was a bench test at Nelson Laboratories to demonstrate substantial equivalence to existing predicate devices. This type of study primarily focuses on performance specifications rather than clinical outcomes with human subjects.

Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated. The document refers to "independent laboratory testing," suggesting a series of tests were performed on a sample of RespAide™ devices.
   • Data Provenance: The testing was performed at Nelson Laboratories, an independent laboratory. The country of origin for the data is not explicitly stated but is likely the United States, given the context of the FDA submission. This was a retrospective analysis of the device's performance against established standards.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This question is not applicable in the context of this study. The "ground truth" here is objective physical standards and criteria for filtration and airflow, rather than expert interpretation of medical data (e.g., imaging, pathology). The laboratory tests themselves establish the performance against these objective standards.

3. Adjudication Method for the Test Set:

   • Not applicable. Since the "ground truth" is objective performance against physical standards measured by laboratory equipment, there is no need for expert adjudication in the traditional sense (e.g., 2+1 physician review).

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Data: Not available." This indicates that no studies involving human readers or clinical outcomes were conducted or provided for this submission. The focus was solely on the physical performance characteristics of the device.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Not applicable. This device is a physical medical device (CPR mask) and not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

6. The Type of Ground Truth Used:

   • The ground truth used was objective physical performance standards for filtration and differential air flow, consistent with industry standards. These are measurable physical properties, not clinical outcomes, pathology, or expert consensus on medical findings.

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The study pertains to a physical product.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to be established in that context.

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