(76 days)
SleepBite is prescribed for the patient by the healthcare professional.
- A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
- B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea.
- C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units. The connectors between the upper and lower plates are flexible elastomeric tubes that have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.
The provided text describes a medical device called "SleepBite," a mandibular advancement device intended for anti-snoring and sleep bruxism. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
It primarily focuses on:
- Device identification: Trade name, common name, classification.
- Substantial equivalence: Comparing SleepBite to existing predicate devices (EMA and Silent Nite).
- Description: How the SleepBite device works, its adjustable screw mechanism, and flexible connectors.
- Intended Use: Specific indications for which the device is prescribed.
- Technological Characteristics: Highlighting the differences and similarities with predicate devices.
- Regulatory clearance: The FDA's 510(k) clearance letter, indicating substantial equivalence.
Therefore, based on the provided text, I cannot answer most of your questions as the information is not present in the document.
Below is a table reflecting the absence of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Regarding the other questions:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The document is primarily a device description and regulatory clearance, not a clinical study report.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- 8. The sample size for the training set: Not applicable and not described.
- 9. How the ground truth for the training set was established: Not applicable and not described.
In summary, the provided document does not contain the detailed study information regarding acceptance criteria, performance metrics, or clinical trial design that your questions refer to. It is a regulatory submission focused on demonstrating substantial equivalence to previously cleared devices.
§ 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.”