(338 days)
Rest Assure is an intraoral device intended to be used in the treatment of snoring and mild to moderate obstructive sleep apnea in patients over 18. Rest Assure has the capability to record and monitor patient compliance to oral device/appliance therapy.
The SomnoDent intraoral devices functions as a mandibular repositioner, which acts to increase the patient's pharvngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to breather during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the sleep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.
This Rest Assure System consists of two appliances, namely the Rest Assure Elite Appliance with (formerly the SomnoDent Herbst commercially distributed under K150369) and the Rest Assure Avant. Both hold current 510(k) clearances from FDA, K150369 for the SomnoDent Herbst Advanced with embedded micro-recorder and K183443 for the SomnoDent Avant.
The provided FDA 510(k) summary for the "Rest Assure System" does not contain the acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document states that "clinical testing was not required or performed." Therefore, there is no clinical study described that would establish acceptance criteria for device performance based on patient outcomes, nor details on a clinical test set, expert adjudication, or MRMC studies.
The performance testing section (8.0) lists various engineering and regulatory compliance tests:
- A. Software Testing per IEC 62304
- B. Safety Testing by UL per 60601-1 series
- C. EMC Testing per 60601-1-2
- D. Risk Analysis per ISO 14971
- E. Cybersecurity Evaluation and Assessment
- F. Co-existence Testing and Assessment
- G. Biocompatibility Assessment
- H. Usability Testing per IEC 62366
- Further, functional and systems testing was performed to demonstrate requirements were successfully completed to demonstrate compliance with the device requirements and specifications.
These tests are primarily focused on safety, electromagnetic compatibility, usability, software quality, and biocompatibility, as per regulatory standards, rather than clinical performance metrics like sensitivity, specificity, or improvement in a medical condition. The document concludes that based on these engineering tests and the device's similarity to predicates, it is "safe and effective for its intended purpose."
Therefore, I cannot populate the table and answer the subsequent questions as the information is not present in the provided text.
§ 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.”