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

eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI

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

Ask a specific question about this device

eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce mild obstructive sleep apnea (AHI

eXciteOSA® is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the to reduce mild obstructive sleep apnea (AHI

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