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The SomnoMed MAS RxA is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Somnomed MAS RxA is an intraoral device used for treating Snoring and Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and which are positioned in relation to each other by an adjustable mechanism consisting of adjustable lugs. The device functions as a mandibular advancement device and enlarges the patient's pharyngeal space, improving 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 to be set by the dentist or physician at the time of fitting the device.

The provided text is a 510(k) summary for the SomnoMed MAS RxA, a mandibular advancement device. It outlines the device's description, indications for use, and a summary of equivalence to a predicate device (MDSA K042161). However, it does not contain any information regarding specific acceptance criteria, performance data from a study, sample sizes, expert qualifications, or ground truth establishment.

The document is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to a legally marketed predicate device rather than providing a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the given text.

The text focuses on:

• Description of the Device: It's an intraoral device with two custom-fitted trays and adjustable lugs to improve air exchange during sleep.
• Indications For Use: To reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Summary of Equivalence: It states that the Somnomed MAS RxA is substantially equivalent to the Bird MDSA device. The primary difference noted is in the adjustable mechanisms (locking clasp for MDSA vs. interlocking lugs and wings for Somnomed RxA). It also mentions that the materials used (dental acrylic, adjustment screws, ball clasps) have prior 510(k) approval.
• Risk Assessment: Concluded no new safety concerns.

In summary, the provided document is a 510(k) summary for regulatory clearance based on substantial equivalence, not a detailed performance study report.

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