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The ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is disposable and for single patient use. It is for use on adult patients (> 30 kg), who are appropriate candidates for noninvasive ventilation and use in a hospital/institutional environment.

THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask provides a seal around the nose and mouth such that pressure from a positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable headgear. The design consists of latex-free silicone cushion connected to a molded polycarbonate frame with an elbow that can swivel 360°. The elbow shall have an interconnection mating with the tubing from the positive pressure device. The interconnection shall conform to ISO 5356-1 (EN1281-1) with a 22mm female connector that can also swivel through 360°. This mask can be used to deliver positive pressure therapy to patients requiring pressures up from 3 to 40 cmH2O. This mask can be used with a range of devices that provide a low level of pressure and that have a mechanism to adequately remove exhaled gases as well as a safety valve that opens to atmosphere to provide room air in the event of loss of supply pressure. THE ADVANTAGE SERIES® Non-vented (NV) Full Face Mask is functionally similar to Cardinal Health Advantage Series Full Face mask (K043382) except that it does not have the anti-asphyxia or an exhalation port. Due to the fact that this is a non-vented mask, there is a need for a separate mechanism to remove exhaled gases.

The provided text describes a 510(k) submission for a medical device, the ADVANTAGE SERIES® Non-vented (NV) Full Face Mask. The submission focuses on its substantial equivalence to predicate devices and results from non-clinical performance testing.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for each test conducted during the "non-clinical performance testing." It only states that the device "was tested under various conditions using the Cardinal Health design control process." The data provenance is internal to Cardinal Health, and it is a retrospective evaluation of the device's design parameters through bench testing, not involving human subjects or real-world data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The non-clinical performance testing appears to be objective bench testing against established specifications and international standards (e.g., ISO 5356-1 for interconnection). Therefore, "ground truth" in the traditional sense (e.g., expert consensus on medical images) is not applicable here. The "ground truth" would be the successful adherence to engineering specifications and performance benchmarks.

4. Adjudication Method for the Test Set

This information is not applicable as the testing described is non-clinical performance testing against objective criteria, not a subjective evaluation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical medical mask, not an AI-powered diagnostic or assistive technology. The study described is bench testing of the mask's physical performance characteristics.

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

This question is not applicable. The device is a physical mask for non-invasive ventilation, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing was based on established design specifications, international standards (e.g., ISO 5356-1), and pre-defined test criteria for physical device performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a training set. The "design control process" refers to the engineering and development process, not machine learning training.

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

This information is not applicable for the same reasons as #8.

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