(99 days)
The DNA Appliance is intended to reduce snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
The DNA appliance is an intraoral device to reduce snoring, and/or mild to moderate sleep apnea in adults 18 years of age and older. It consists of either an upper tray, or both, and is designed to open the airway during sleep. The device is customized to each patient, and features an adjustment mechanism to allow it to be further customized to each patient.
The device is identical to the already-marketed mRNA appliance except the top and bottom trays do not interlock to advance the jaw.
The provided text does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving that the device meets such criteria. The document is a 510(k) premarket notification for the DNA Appliance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (mRNA appliance) rather than presenting performance data against defined acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document primarily focuses on:
- Device Description: The DNA Appliance's components, mechanism of action, and customization.
- Intended Use: Reducing snoring and/or mild to moderate obstructive sleep apnea in adults 18 years and older.
- Comparison to Predicate Device: Highlighting similarities in mechanism, design (except for mandibular advancement), materials, cleaning instructions, and labeling with the mRNA appliance.
- Testing: Mentioning a risk analysis and reliance on peer-reviewed literature and Real-World Data (RWD) to demonstrate the DNA Appliance's ability to reduce snoring and sleep apnea, asserting no new safety and efficacy questions compared to the predicate device.
To answer your specific questions, I would need a different type of document, such as a clinical study report or a detailed device performance evaluation.
§ 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.”