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The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.

This document describes a 510(k) premarket notification for a medical device called the "Revolution Full Face Mask" by Respironics, Inc. This is a submission to demonstrate substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to prove efficacy against specific acceptance criteria for an AI or medical device's diagnostic performance.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device's performance metrics (like sensitivity, specificity, etc.) is not directly applicable to this document. This document focuses on demonstrating that the modified Revolution Full Face Mask is as safe and effective as its predicate devices through non-clinical testing and comparison of technological characteristics.

However, I can extract information related to the device's performance testing and the standards it aims to meet, which can be interpreted as the "acceptance criteria" for demonstrating substantial equivalence for this type of medical device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Tests" (Page 6).

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. This refers to the number of physical masks or components tested in the non-clinical performance evaluations. Given it's a device modification and non-clinical, typical engineering test sample sizes would be used, but the exact numbers are not provided in this summary.
• Data Provenance: The tests were performed by Respironics, Inc. The nature of these tests (e.g., bench testing, material analysis) means the "provenance" isn't country-specific in the way clinical trial data might be. These are likely internal lab tests. They are retrospective in the sense that the testing was performed on the device modification before submission, to compare against a baseline or standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable to a non-clinical device performance test of this nature. "Ground truth" is established by engineering specifications, validated test methods, and compliance with recognized standards (ISO standards mentioned). No human experts are used to establish "ground truth" for physical device performance in the way they would be for image interpretation by an AI.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in studies where subjectivity plays a role (e.g., interpreting medical images). The non-clinical tests described here are objective engineering measurements.

5. 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:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This device is a physical mask for respiratory therapy.

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

• Not applicable. This device is a physical medical device, not an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is defined by:
  • Engineering specifications and design requirements of the mask.
  • Requirements and methodologies outlined in the referenced ISO standards (ISO 17510-2, ISO 10993-1, ISO 14971).
  • Performance of the predicate devices (K082866, K073600) to which substantial equivalence is claimed.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI algorithm developing a model.

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

• Not applicable. There is no "training set" or corresponding "ground truth" for a training set.

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