Search Results

The Snore Guard Advance is intended to be used for the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.

The Snore Guard Advance consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.

This 510(k) summary for Ranir's Snore Guard Advance does not provide the requested information about acceptance criteria and a study proving the device meets those criteria. The document is a premarket notification for a Class II medical device, focused on demonstrating substantial equivalence to a predicate device rather than presenting performance study results against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details based on the provided text.

The summary states:

"The Snore Guard Advance has the same intended use and similar indications, principles of operation, and technological characteristics as Hays & Meade Anti-Snoring Device. The minor differences in the Snore Guard Advance's technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Snore Guard Advance is substantially equivalent to its predicate devices."

This indicates that the primary proof was demonstrating equivalence to an already approved device, rather than conducting a new clinical study with predefined acceptance criteria for efficacy and safety.

Ask a specific question about this device