(64 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 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:
- 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.
- Sample sized used for the test set and the data provenance: Not applicable, as no tests were performed.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no tests were performed.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no tests were performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no tests were performed.
- The sample size for the training set: Not applicable, as no new training was performed or reported.
- 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.
§ 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.