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The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system.
-The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment.
-The mask is intended for single-patient use in the hospital or institutional environment.

These masks act as an interface for CPAP/BPAP device and deliver pressurized air to prevent apnea from occurring. The masks consist of several parts which includes frame, cushion, elbow, swivel, and headgear. The frame provides support for the mask, the cushion provides the seal, the elbow is designed to provide a vent for exhaust gas and a valve to prevent asphyxiation. The swivel can be rotated 360 degrees, which can help prevent pipe winding. The size of the connector port of the swivel is consistent with ISO standards and can be connected to any tube which conforms to the same standard. The headgear is used to fasten the mask to the face. The masks can be disassembled without any tools.

This document describes the non-clinical testing performed to demonstrate substantial equivalence for the Sleep Apnea Breathing Therapy Masks (YF-01, YF-02, YF-03 Full Face Mask; YN-02, YN-03 Nasal Mask; YP-01 Nasal Pillows Mask). The study focuses on comparing the subject devices to predicate devices based on various technical specifications and adherence to recognized standards.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly provide a separate table of defined acceptance criteria alongside reported device performance in the format requested. Instead, it presents a comparative analysis with predicate devices across several technical specifications. The "Comment" column often describes whether the subject device meets relevant standard requirements or how differences are deemed acceptable.

However, based on the comparative tables provided across pages 5-13, we can infer the acceptance criteria are generally that the subject device's performance is comparable to or better than the predicate devices, and/or meets relevant international standards.

Here's a summary of the technical specifications and reported performance for the Subject Device for the Full Face Mask comparison (YF-01, YF-02, YF-03 Full Face Mask vs. predicate AirFit F20), as an example:

Similar tables are provided in the document for Predicate Device AirFit N20 against YN-02, YN-03 Nasal Mask and Predicate Device Swift™ FX against YP-01 Nasal Pillows Mask. The acceptance criteria are consistent across all comparisons, emphasizing meeting relevant standards and comparability to predicate devices without raising new safety or effectiveness concerns.

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

The document describes non-clinical tests conducted to verify design specifications and substantial equivalence. These tests are typically laboratory-based assessments of performance characteristics.

• Sample size: Not explicitly stated for each test. The tests are general engineering and biocompatibility evaluations, implying multiple samples of the masks would have been tested as per standard protocols.
• Data provenance: Not explicitly stated, but based on the manufacturer's location (Suzhou, Jiangsu, China) and the submission to the FDA, it's likely the tests were conducted in China. These would be prospective tests performed specifically for this submission.

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)

This section is not applicable. The study is a non-clinical, technical performance and biocompatibility assessment of a medical device (sleep apnea breathing therapy masks). It does not involve human subjects, image interpretation, or clinical decision-making where expert ground truth would be established. The "ground truth" here is adherence to engineering standards and comparison against predicate device specifications.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to expert review processes, typically used in clinical studies or when establishing ground truth from human assessments, such as radiology interpretations. This document describes non-clinical engineering and biocompatibility testing. The "adjudication" is met by demonstrating compliance with recognized standards (e.g., ISO 17510:2015, ISO 10993 series) and comparability to predicate devices.

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

This section is not applicable. The device described is a physical medical mask, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This section is not applicable. The device is a physical mask for sleep apnea therapy, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• International Standards: Adherence to standards such as ISO 17510:2015 (Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories), ISO 5356-1:2004 (Anaesthetic and respiratory equipment - Conical connectors), ISO 10993 series (Biological evaluation of medical devices), and ISO 18562 series (Biocompatibility evaluation of breathing gas pathways).
• Predicate Device Specifications: Comparative data showing that the subject device's technical specifications (e.g., pressure range, resistance to flow, dead space, sound, environmental conditions) are comparable to or within acceptable limits of legally marketed predicate devices.
• FDA Guidance: Compliance with relevant FDA guidance documents, such as "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015."

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

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