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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 tongue in order 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 improve its muscle 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 11 Pro & iPhone 11 Pro Max and above, with iOS 15.0 and higher. The mobile app software can also be used with Bluetooth support and Android 10.0 and above. eXciteOSA® uses Bluetooth Smart; mobile devices used must be compatible with Bluetooth Smart.

The provided document is a 510(k) summary for the eXciteOSA device, which is a neuromuscular tongue muscle stimulator. The document declares that clinical tests were not performed for this specific submission for an updated version of the device. Instead, the submission relies on non-clinical tests and a comparison to a legally marketed predicate device (K223446) which is itself an eXciteOSA device.

Therefore, the following information regarding acceptance criteria and a study that proves the device meets them cannot be extracted from this document, as no new clinical study was conducted for this 510(k) submission. The document explicitly states:

• Clinical tests were not performed. (Page 6)

The document focuses on demonstrating substantial equivalence to the predicate device by highlighting:

• The indications for use are the same as the predicate device.
• The technological characteristics are largely the same, with minor changes due to supply issues (microcontroller replacement) and other minor updates (layout, battery fuel gauge, mouthpiece trigger, moisture detection, LEDs, external DAC, optional extender cable). These minor changes are justified via risk analysis and non-clinical testing, confirming they do not impact functionality or safety.

To answer your request, if a new clinical study were to be performed to assess the effectiveness of the eXciteOSA device in meeting its indications for use (reducing mild obstructive sleep apnea and snoring), the following would be relevant for such a study:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria Examples (Hypothetical, based on device indication):
     • For OSA: A statistically significant reduction in AHI (Apnea-Hypopnea Index) from baseline in a specified percentage of patients (e.g., ≥50% reduction in AHI for at least 50% of patients diagnosed with mild OSA) OR AHI change to below a certain threshold (e.g. AHI < 5)
     • For Snoring: A statistically significant reduction in objective snoring measures (e.g., snore intensity, snore time) or subjective patient-reported snoring severity.
     • Safety: Incidence of serious adverse events (SAEs) ≤ a predefined threshold (e.g., <5%).
   • Reported Device Performance: This would be the actual outcomes from a clinical trial, such as the mean AHI reduction, proportion of responders, and adverse event rates.

2. Sample size used for the test set and the data provenance: This would depend on the power analysis for the clinical trial and the study design (e.g., prospective, multi-center).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For OSA, ground truth would typically be established by certified sleep physicians interpreting overnight polysomnography (PSG) studies.

4. Adjudication method for the test set: For PSG interpretation, it's often a single blinded sleep physician, or sometimes two physicians with a third for discrepancies.

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: This type of study is not directly applicable to a device like eXciteOSA, as it's a therapeutic device, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a therapeutic device.

7. The type of ground truth used:

   • For OSA: Gold standard would be polysomnography (PSG)-derived AHI.
   • For Snoring: Objective measures from PSG (e.g., snore events, loudness) and/or validated subjective snoring questionnaires.

8. The sample size for the training set: Not applicable as no new clinical study was performed, and this is not a machine learning algorithm being trained in this specific submission.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for eXciteOSA focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical testing of minor engineering changes. It does not include a new clinical study to establish performance against acceptance criteria.

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