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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:

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