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The PerforMax Pediatric SE Total 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 for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.

The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation when 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. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose and mouth. It is held in place with an adjustable bonnet headgear. It may be cleaned by the professional in the hospital/institutional environment through a thermal high-level disinfection process or a chemical highlevel disinfection process for multi-patient use.

The PerforMax Pediatric SE Total Face Mask consists of a faceplate with a bonded silicone seal for the face. A 22 mm standard elbow is connected to the elbow hub on the faceplate. The 22 mm elbow is used to connect a conventional air delivery hose between the mask and the positive airway pressure source. The bonnet headgear is connected to the mask through slots in the upper part of the frame and clips that attach to the lower part of the frame. The mask is designed in such a way that it can be easily disassembled for disinfection or to replace several of the mask components, such as the headgear and elbow.

This document describes the PerforMax Pediatric SE Total Face Mask, a patient interface for noninvasive ventilation. The submission declares that the device is substantially equivalent to predicate devices based on non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in a table format with corresponding performance metrics. Instead, it states that "extensive performance testing was completed" to demonstrate functionality was unaffected by changes from predicate devices. The overarching acceptance criterion implicitly is that the device "meets its performance specifications" and "raises no new issues of safety or effectiveness."

Implicit Acceptance Criteria and Performance:

Study Details

Based on the provided text, this submission relies on non-clinical bench testing rather than clinical studies involving human subjects or AI algorithms. As such, many of the requested fields are not applicable to this type of regulatory submission.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not specified quantitatively. The document refers to "extensive performance testing" but does not give specific numbers of masks or test cycles.
   • Data Provenance: Not specified. The testing was likely conducted in a lab environment by the manufacturer (Respironics, Inc. based in Murrysville, PA). The testing appears to be prospective as it was performed specifically for this 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This was a non-clinical bench test. "Ground truth" would refer to established engineering and material science standards, and the expertise would be in test engineers and quality assurance personnel rather than medical experts for clinical ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This relates to clinical studies and expert review for ground truth establishment.

4. 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. This is a medical device for ventilation, not an AI-assisted diagnostic or imaging device. No AI component is mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. No AI algorithm is involved.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical tests, the "ground truth" was established by recognized industry standards and FDA guidance documents for medical device performance, disinfection, and biocompatibility. Examples cited include AAMI TIR No. 12-2004, AAMI TIR 30-2003, ASTM E1837-96 (2007), FDA CDRH guidance on sterilants/disinfectants, and ISO 10993-1 for biocompatibility.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device; therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set.

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