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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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