(75 days)
To be used for the treatment of simple snoring in both dentate and edentult patientis. Can be used also for the treatment of snoring in patients with periodontically comprised dentitions and likewise patients presenting with Tempero-mandibular Dysfunction (TMD). Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyIngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function.
TONGUE STABILIZING DEVICE
I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device, a "Tongue Stabilizer Device" for the treatment of simple snoring, is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document explicitly mentions "Cephalometric and videoendoscopy studies have established that tongue protrusion creates a greater, increase in oropharyngeal, velopharyngeal and hypopharyngeal cross-sectional areas of the upper airway, hence improving airway patency and function." However, details about these studies, such as their acceptance criteria, specific results, sample sizes, or ground truth methodology are not provided in this regulatory letter.
§ 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.”