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The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnoea.
The Airwayease MAS is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The Airwayease MAS is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnoea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of interchangeable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep.
The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement as well as vertical change to be set by the dentist or physician at the time of fitting the device.
The ranges of mandibular advancement are up to 7mm from the starting point of the construction bite supplied by the dentist, as well as 7mm of vertical opening from the starting point of the construction bite supplied by the dentist.
Lateral movement of the jaw is limited by the device and as such this device is contra-indicated for those patients requiring the ability to move their lower jaw in a lateral direction whilst wearing the device.
Vertical opening for the Airwayease MAS is unrestricted except by that of the patient's individual physiology.

The provided 510(k) summary for the "Airwayease MAS" device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a typical 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo performance study with specific acceptance criteria.

Therefore, I cannot populate the table or provide details about a study with the specific elements requested (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details) because this information is not present in the provided text.

The document primarily focuses on:

• Device Description: What the Airwayease MAS is and how it functions.
• Intended Use and Target Population: Who the device is for and what it treats.
• Material Composition: Details about the materials used and their prior clearance/biocompatibility.
• Comparison to Predicate Device: A detailed comparison table highlighting similarities and differences with existing devices (SomnoMed MAS flex K0703004, OASYS K030440, TAP III K062951).
• Substantial Equivalence Claim: The core argument for 510(k) clearance, stating that differences in materials do not significantly affect safety or effectiveness.
• FDA Clearance Letter: Official communication from the FDA confirming clearance based on substantial equivalence.

In summary, none of the requested study design and results information is available in the provided text.

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