Search Results

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:

Study Details:

1. 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.
2. 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.
3. 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.
4. Adjudication Method: Not applicable. No new study data for the NOrAD device is presented requiring adjudication. The performance metrics are extracted from published literature.
5. 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.
6. 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).
7. 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.
8. Sample Size for Training Set: Not applicable. The document does not describe the development or training of a software algorithm for the NOrAD device.
9. How Ground Truth for Training Set Was Established: Not applicable. No training set for an algorithm is described.

Ask a specific question about this device

The NOrAD device is indicated for use in patients who are snorers and wish to reduce or otherwise manage their snoring while sleeping.

The device is to be used with individuals in whom it has been determined that they are primary snorers and are not at risk for sleep apnea. In many instances these individuals may have had a sleep study and have been found to have a Respiratory Disturbance Index (RDI) below the level that necessitates a diagnosis for sleep apnea. They may also be individuals who are snorers and whose physician has determined that they are not candidates for a sleep study and may proceed with management of their snoring utilizing this device. Many times this decision will have been achieved after consultation has occurred between the dentist and their 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 provided text is a 510(k) Premarket Notification summary for the NOrAD (Nocturnal Oral Airway Dilator) device. It describes the device, its intended use, and claims substantial equivalence to predicate devices for the management of snoring. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial results or performance studies reporting quantitative metrics.

Instead, the submission relies on non-clinical data and existing literature reviews to support its claims of substantial equivalence for snoring reduction.

Here's a breakdown of why I cannot provide the requested information based on the input:

• No Acceptance Criteria: The document does not define specific, quantifiable acceptance criteria for the NOrAD device's performance (e.g., "snoring reduction > X%," "AHI improvement > Y").
• No Dedicated Study for NOrAD Performance: The submission does not describe a prospective or retrospective study explicitly designed to measure the NOrAD device's performance against predefined criteria.
• Reliance on Literature/Predicate Devices: The submission states, "Substantial Equivalence is based on non-clinical data as it relates to the historical significance of oral devices that reposition the jaw and reduce or mange snoring." It cites:
  • Pancer et al. (1998) in CHEST: "mandibular repositioning appliances were 95% successful in reducing and/or controlling snoring."
  • American Academy of Sleep Medicine (1995) Standards of Practice and Guidelines: "demonstrated that oral appliances were effective in the management of snoring."
  • "Based on clinical data, repeatedly demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring, oral appliance therapy is an effective means by which snoring can be managed."
  • "a number of studies have shown improvement of the airway utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), which aids in the management and reduction of snoring."

Since no specific study for the NOrAD device's performance is detailed in the submission, I cannot extract the requested information.

Conclusion:

The provided 510(k) summary does not contain the information necessary to answer the request regarding specific acceptance criteria, a dedicated study proving device performance, sample sizes, expert qualifications, or ground truth establishment for the NOrAD device itself. The submission rests its case on the general efficacy of the class of devices (mandibular repositioning appliances for snoring) as demonstrated in existing scientific literature and the performance of its predicate devices.

Ask a specific question about this device