Search Results

eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older.

eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the to reduce mild obstructive sleep apnea (AHI <15) and snoring for patients that are 18 years or older. The small electric currents delivered through the mouthpiece stimulate the tongue and improved function. The improved function of the tongue muscle will help in keeping the upper airway open during sleep and reduce the vibration of the throat region. Two tabs of the mouthpiece sit comfortably above and below the tongue. The mouthpiece is designed such that when the mouth is gently closed, it will naturally sit around the tongue and won't move during the therapy session. The device can be used at any point during the day. The device can be controlled by a smartphone application. This app can be downloaded from the App store (Apple iOS) or Play Store (Google Android). The mobile app software can be used on iPhone 6/6 Plus, iPhone 6/6s Plus, iPhone 7/7 Plus, iPhone 8/8 Plus, iPhone X, with iOS 11.0 and higher. The mobile app software can also be used with Android devices with BLE support (Bluetooth 4.0) and Android 7.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.

The provided text is a 510(k) summary for the eXciteOSA device. It states that non-clinical and/or clinical tests were not performed because the "subject device are the same and no physical changes were made" compared to the predicate device (DEN200018).

Therefore, based on the input text:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The submission explicitly states no tests were performed.
2. Sample sized used for the test set and the data provenance: Not applicable, as no tests were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no tests were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no tests were performed.
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, as no tests were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no tests were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no tests were performed.
8. The sample size for the training set: Not applicable, as no new training was performed or reported.
9. How the ground truth for the training set was established: Not applicable, as no new training was performed or reported.

The 510(k) submission states that the device is substantially equivalent to the predicate device (DEN200018) and that the differences (deletion of some contraindications and minor software/firmware updates) were not critical to the intended therapeutic use and did not require new testing.

Ask a specific question about this device