(83 days)
The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient's responses to a questionnaire, indicate the possibility of a more serious sleep disorder than "primary" or "social" snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea when surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient's responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist's examination and the patient's responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.
The SilentNite™ device is comprised of upper and lower frames that are attached with connectors. The frames are form fitted to the teeth and are meant to be worn at night while sleeping.
The provided text is a 510(k) Premarket Notification Submission for the SilentNite™ Snore Prevention Device, dated June 25, 1997. It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document is a regulatory submission for market clearance based on substantial equivalence, not a clinical study report that would detail the performance metrics you're asking for. The section on "Safety and Efficacy" explicitly states: "The effectiveness and suitability to the intended purpose of the product is assured through the wide, general use of similar other predicate devices and demonstrates the safe use of the device in many practitioner's hands." This indicates that a specific study proving the device meets defined acceptance criteria was likely not performed or submitted as part of this particular regulatory pathway.
Therefore, I cannot extract the requested information from the provided text.
§ 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.”