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The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.

The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).

This document is a 510(k) summary for a Nasal Pillow Mask, indicating that the device is substantially equivalent to a previously cleared predicate device. As such, it highlights the lack of a new study to demonstrate acceptance criteria because the device is deemed identical to its predicate in all relevant aspects.

Here's the breakdown of why the requested information cannot be fully provided based solely on the input, and what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Therefore, no new non-clinical testing is required."

This means that for the current 510(k) submission (K243225), no new acceptance criteria or reported device performance data was generated or provided for the subject device. The acceptance criteria and performance data would have been established and demonstrated for the predicate device (K120920) in its original submission.

The table in the document provides specifications for Deadspace Volume, Resistance, Therapy pressure, Noise level, Environmental Conditions, Weight, and Size Flow, which are common technical specifications for such devices. These are not explicitly stated as "acceptance criteria" but rather as "Specifications" that are "Same" as the predicate.

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

• No new sample size or test set was used for the subject device as "no new non-clinical testing is required." Testing relevant to these specifications would have been performed for the predicate device.
• Data provenance: Not applicable for the subject device's 510(k) as no new studies were conducted. The origin of the predicate device's data is not provided in this document.

3. 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. No expert ground truth establishment was conducted for the subject device's 510(k), as it leveraged the equivalence to a predicate device.

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

• Not applicable. No new test set or expert adjudication was performed for the subject device.

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. This device is a physical medical device (nasal pillow mask), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of AI assistance is irrelevant and was not performed.

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

• No. This device is a physical medical device and does not involve an algorithm.

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

• Not applicable for the subject device's 510(k). The substantial equivalence determination is based on the device being identical to the predicate in design, materials, and intended use, not on new clinical performance data or ground truth establishment for the subject device. The specifications listed are objective physical measurements.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

• Not applicable. As above, no training set was used.

In summary of the provided document:

The 510(k) submission for the Nasal Pillow Mask (K243225) is based on the premise of substantial equivalence to a predicate device (Hsiner Nasal Pillow Mask, K120920). The manufacturer asserts that the subject device is identical to the predicate device in terms of indications for use, design, principles of operation, and materials. Therefore, no new performance studies, acceptance criteria demonstration, or clinical data were generated for the subject device. The FDA's clearance is based on the established safety and effectiveness of the predicate device, which the subject device is claimed to replicate.

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