(45 days)
The OVENT is a removable medical device that is fitted in the patient is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions.
The OVENT is for prescription use only.
The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of:
• A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth.
• A dental polymer material in each tray which is in contact with and retaining in position, the user's top and bottom teeth.
• The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user's snoring condition.
• A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.
The provided text, a 510(k) summary for the OVENT device, does not describe any clinical studies conducted to prove the device meets acceptance criteria. Instead, it explicitly states:
"Human clinical studies were not deemed necessary to evaluate the performance of the device to determine substantial equivalence as the OVENT does not:
- Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
- Use new technologies different from legally-marketed intramandibular repositioning devices for snoring and/or obstructive sleep apnea;
- Deviate from the indications for use identified in the predicate devices: the TAPIII and the LISA."
Therefore, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them, as no such study is detailed in this document.
The document does include non-clinical tests performed, such as biocompatibility and peel/bond strength testing. These tests had certain acceptance criteria, but they are not clinical performance measures.
Here's a summary of the non-clinical test information:
Non-Clinical Acceptance Criteria and Reported Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO-10993 Part 5) | Passed |
| Skin Sensitization (ISO-10993 Part 10) | Passed |
| Intraoral Mucosa Irritation (ISO-10993) | Passed |
| Intracutaneous Reactivity (ISO-10993) | Passed |
| Peel/Bond Strength: | |
| Bond Strength (Titanium to Acrylic) | Pass/fail criterion: 1N/mm or 10N overall strength for a 10mm interface length. The OVENT materials before and after aging had peak strengths greater than 1N/mm (>10N for a 10mm wide sample), meeting the criterion. |
| Peel Strength (Acrylic to Dental Laminate) | Pass/fail criterion: 1N/mm or 10N overall strength for a 10mm interface length (tested as per DD253-2001). The key objective was to ensure that any degradation at the interfaces did not result in oral fluid ingression. |
Regarding Clinical Studies:
- Sample size for the test set and data provenance: Not applicable, no clinical test set described.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, no clinical test set described.
- Adjudication method for the test set: Not applicable, no clinical test set described.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, no clinical study described.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, device is a physical intraoral appliance, not an algorithm.
- The type of ground truth used: Not applicable, no clinical ground truth established.
- Sample size for the training set: Not applicable, no algorithm or clinical device training described.
- How the ground truth for the training set was established: Not applicable, no algorithm or clinical device training 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.”