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The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access

Here's a breakdown of the acceptance criteria and the study information for the Genuine First Aid CPR Mask, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for the performance tests (expiratory and inspiratory resistance, and biocompatibility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). However, given that these are physical performance tests for a medical device submitted to the FDA in the US, it's highly likely they were conducted in a controlled laboratory environment to meet regulatory standards, but the specific details are not disclosed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The device is a CPR mask, and the "ground truth" for its performance is based on measurable physical properties (resistance) and established biocompatibility standards, not expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing discrepancies in expert interpretation, which is not relevant for the type of performance testing performed on this device. The results are based on objective measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is commonly employed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance, which is not relevant for a physical medical device like a CPR mask.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI system, but a physical medical device. The "standalone" performance here refers to the device's inherent physical characteristics.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Established industry standards: Specifically, ISO10651-4:2002 for pulmonary resistance measurements and ISO10993-1,-5,-10 for biocompatibility.
• Objective physical measurements: The expiratory and inspiratory resistance values are quantitative measurements of the device's physical properties.
• Laboratory-based biological testing: Biocompatibility tests (cytotoxicity, irritation, hypersensitivity) are conducted in a lab against established biological endpoints.

8. The Sample Size for the Training Set

This information is not applicable. The Genuine First Aid CPR Mask is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8. There is no training set for this device.

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The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access

This document describes the performance testing of the Genuine First Aid CPR Mask.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided document does not specify a distinct "test set" in the context of a typical AI/software device evaluation. The performance metrics listed (expiratory and inspiratory resistance) refer to a single device (the Genuine First Aid CPR mask) being tested against established industry standards. Biocompatibility testing results are also presented for the device.

There is no information on:

• The sample size used for the resistance and biocompatibility tests.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. This device is a physical medical device (CPR mask), not an AI or software device that requires expert-established ground truth for a test set. The performance is assessed against recognized engineering and biological standards.

4. Adjudication Method for Test Set

Not applicable. As noted above, this is a physical device, not an AI/software device requiring an adjudication process for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a CPR mask and not an AI or imaging device for which MRMC studies are typically conducted to assess the impact of AI assistance on human readers.

6. Standalone Performance

Yes, standalone performance was done. The document directly reports the performance of the Genuine First Aid CPR mask for expiratory and inspiratory resistance, and biocompatibility in isolation, without involving human users for comparative analysis in these specific tests.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria is based on:

• Established industry standards: Specifically, ISO10651-4:2002 for lung ventilators (for resistance measurements) and ISO10993-1, -5, -10 for biological evaluation of medical devices (for biocompatibility). These international standards define the acceptable limits for the device's physical and biological properties.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set" in the sense of data used to train a model.

9. How Ground Truth for Training Set was Established

Not applicable. As this device does not involve an AI/machine learning model, there is no training set or associated ground truth establishment process.

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