(42 days)
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”