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The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.

The provided 510(k) submission for the Hsiner Company CPAP Masks does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The submission primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use. There is no mention of a clinical or performance study with detailed methodologies (sample sizes, expert involvement, adjudication, etc.) in the provided text.

Therefore, I cannot fulfill your request for the tables and study details based on the given input, as this information is not present in the document.

The document states: "The Hsiner CPAP/VPAP Masks is equivalent in design, materials and performance to the Predicate devices. All the predicate devices utilize the same principles of operation and have the same intended use." This suggests that the substantial equivalence argument relies on the inherent characteristics of the device and its similarity to already approved devices, rather than a separate performance study with acceptance criteria.

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