(70 days)
The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping.
The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.
This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.
The NOrAD device is intended for the reduction and management of snoring and sleep apnea. Equivalence is based primarily on non-clinical characteristics and existing literature on mandibular repositioning appliances.
Acceptance Criteria and Device Performance:
| Acceptance Criteria (Success Rate for Mandibular Repositioning Appliances) | Reported Device Performance (NOrAD is substantially equivalent to devices with this performance) |
|---|---|
| Reduce and/or control snoring by 95% | The NOrAD is substantially equivalent to mandibular repositioning appliances which have been reported to reduce and/or control snoring by 95%. |
| Manage sleep apnea by 83% | The NOrAD is substantially equivalent to mandibular repositioning appliances which have been reported to be 83% effective in managing sleep apnea. |
Study Details:
- Sample Size: Not applicable. The submission refers to a literature review and does not present data from a new study with a specific sample size.
- Data Provenance: The provenance of the data supporting the acceptance criteria is from existing literature. Specifically, a study by Pancer et al. published in the journal CHEST in 1998 is cited. This would be retrospective in relation to the NOrAD submission. The country of origin is not specified but implicitly North American, given the references to the American Academy of Sleep Medicine.
- Number of Experts and Qualifications: Not applicable. The document cites existing academic literature and professional guidelines, not a specific expert review for this device's performance.
- Adjudication Method: Not applicable. No new study data for the NOrAD device is presented requiring adjudication. The performance metrics are extracted from published literature.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No MRMC study was conducted or referenced for the NOrAD device. The submission relies on established effectiveness of oral appliances in general.
- Standalone Performance Study: Not explicitly stated as a standalone study for the NOrAD device itself. The evidence for effectiveness is based on published literature regarding a class of similar devices (mandibular repositioning appliances).
- Type of Ground Truth: The ground truth for the acceptance criteria (95% for snoring, 83% for sleep apnea) is based on the findings reported in the Pancer et al. article and implicitly from the "Standards of Practice and Guidelines" published by the American Academy of Sleep Medicine. This would be considered clinical outcomes data as reported in academic literature.
- Sample Size for Training Set: Not applicable. The document does not describe the development or training of a software algorithm for the NOrAD device.
- How Ground Truth for Training Set Was Established: Not applicable. No training set for an algorithm is described.
§ 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.”