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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

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

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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

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.

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

The eXciteOSA device is an external tongue muscle stimulator that delivers neuromuscular electrical stimulation to intrinsic and extrinsic tongue muscles in the daytime in order to increase muscle tone and prevent excess tongue muscle relaxation during sleep. The device is indicated to reduce snoring and mild obstructive sleep apnea in adults 18 years and older. The device is placed in the mouth, with electrodes located above and 10 10 electrodes located below the tongue. The therapy consists of a series of pulse bursts with rest periods and is used for 20 minutes during wakeful state for a period of 6-weeks. The electrical stimulation is directed at the tongue and in particular at a group of muscles comprising the genioglossus muscle, the biggest muscle in the oral cavity. The device is intended to use the established technology of neuromuscular electrical stimulation (NMES) for the muscles of the oral cavity as a training tool in awake individuals to improve the tone of their throat muscles and reduce the problem of snoring and mild OSA during sleep. The eXciteOSA is a system made out of different components and sold in different configurations. The device consists of three components: 1) Washable Flexible Electrode Mouthpiece with electrode array that fits onto the tongue. 2) Rechargeable Control Unit that attaches to the mouthpiece via a USB-C connection. 3) Remote Control Unit and/or Smartphone App that manages the functions of the device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

eXciteOSA Device Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

Note: Several specific numerical values in the "Reported Device Performance" column are redacted in the original document ("(b)(4)"), which prevents a precise quantitative comparison for certain metrics. However, the text indicates that the primary endpoints for both snoring and mild OSA reduction were met.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Snoring Cohort: (b)(4) patients completed the trial (specific number redacted, but mentioned as "10101 patients" initially).
  • Mild OSA Cohort: (b)(4) patients were considered for statistical analysis (specific number redacted). An initial cohort of (b)(4) total participants included (b)(4) patients diagnosed with mild OSA, but after exclusions based on AHI, and additional patients found, the final analysis was on (b)(4) patients.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be a prospective clinical trial, as participants were recruited, underwent a pre-therapy period, a multi-week therapy phase, and a follow-up phase, with objective and subjective data collected throughout.

3. Number of Experts and Qualifications for Ground Truth

The document does not detail the number or specific qualifications of experts used to establish the ground truth beyond general descriptions:

• Snoring: Bed partner daily subjective assessment (Visual Analog Scale) was a primary endpoint, implying the "ground truth" for snoring perception was the subject's live-in partner. Objective snoring data was collected using (b)(4) (specific methodology redacted).
• Mild OSA:
  • Diagnosis and AHI assessment were based on sleep studies (PSG). It states that only patients initially screened with PSG and demonstrating an AHI between 5-14 were included. The baseline and final assessment were conducted using (b)(4) (likely a type of sleep study equipment/methodology).
  • Clinical airway examination by an ENT surgeon was part of the recruitment visit.
    The text does not specify the number of sleep study readers or ENTs involved in ground truth establishment, nor their specific years of experience.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for the data collected, particularly for the PSG readings or bed partner VAS. The data collection seems to rely on individual assessments (bed partner for VAS, sleep study interpretation for AHI).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on the effectiveness of the device itself through direct patient outcomes, not on how human readers' performance improves with or without AI assistance. The device is a neuromuscular stimulator, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. The eXciteOSA is a physical medical device (neuromuscular stimulator), not a software algorithm or AI model designed for standalone performance in a diagnostic context. Its "performance" is measured by its physiological effect on the user (reduction in snoring/AHI).

7. Type of Ground Truth Used

• Objective Physiological Data:
  • AHI (Apnea-Hypopnea Index): Measured via Polysomnography (PSG) or Home Sleep Apnea Test (HSAT) conducted with (b)(4) equipment. This is a direct physiological measurement related to sleep-disordered breathing.
  • Oxygen Desaturation Index (ODI) and Oxygen Saturation Indices: Also derived from sleep studies.
  • Snoring Time/Levels: Measured objectively using (b)(4) (specific methodology redacted).
• Subjective Outcome Data:
  • Bed Partner VAS for Snoring: Subjective assessment from the live-in partner.
  • Epworth Sleepiness Scale (ESS): Patient-reported questionnaire for subjective sleepiness.
  • Pittsburgh Sleep Quality Index (PSQI): Patient-reported questionnaire for subjective sleep quality.
• Adverse Events: Reported by participants and monitored for safety.

The primary ground truth for efficacy in OSA is objective sleep study data (AHI), while for snoring, it's a combination of objective snoring sound analysis and subjective bed partner reports.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here because the eXciteOSA is a physical medical device that delivers electrical stimulation, not a machine learning model that requires a training set. The clinical study described evaluates the device's efficacy and safety in a test population.

9. How the Ground Truth for the Training Set was Established

As this is not an AI/ML device relying on a training set, this question is not applicable. The "ground truth" for evaluating the device's effectiveness (rather than a model's performance) was established through prospective clinical data collection using established methodologies like PSG, subjective questionnaires, and physical examinations.

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