(101 days)
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:
- 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
- Acceptance Criteria Examples (Hypothetical, based on device indication):
§ 872.5575 Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea.
(a)
Identification. A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate the wireless compatibility, electrical safety, battery safety, and electromagnetic compatibility of the device in its intended use environment.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Patient labeling must include:
(i) Information on device components, setup, and use of the device including placement of sensors and mouthpieces, and images or illustrations;
(ii) A summary of technical specifications;
(iii) Instructions on how to clean and maintain the device;
(iv) A statement that the patient should maintain regular follow up visits with dentist and sleep specialist; and
(v) A statement that patients should have a comprehensive dental examination prior to using this device.
(5) A human factors assessment must evaluate simulated use of the device to demonstrate that the user can correctly use device based on the labeling and instructions for use.