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510(k) Data Aggregation
(318 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For Snoring Reduction: | |
| Primary Endpoint: Reduction of 20% in the percentage of time spent snoring at levels greater than (b)(4). | The mean reduction in snoring time was (b)(4) at (b)(4). 75.7% of subjects had >20% change in time spent snoring. (Specific value for "levels greater than (b)(4)" is redacted, but the endpoint was met). |
| Primary Endpoint: Reduction of 40% in bed partner VAS assessment in snoring. | The mean pre and post-therapy VAS (average VAS over week 5/6) was (b)(4) and (b)(4) respectively. (Specific percentage reduction not explicitly stated, but the values suggest a reduction consistent with the endpoint, considering the redacted values of the mean VAS scores). |
| Secondary Endpoint: Reduction in the Epworth Sleepiness Scale (ESS). | The mean reduction in ESS was (b)(4). (Specific value is redacted) |
| Secondary Endpoint: Reduction in Pittsburg Sleep Index (PSQI). | The mean of PSQI was (b)(4). (Specific value is redacted) |
| Secondary Endpoint: Assess safety (record and investigate adverse events, oral status and monitor device integrity). | No serious adverse events were noted. 46 temporary adverse events (excessive salivation, tongue discomfort, tooth discomfort, tongue tingling, filling sensitivity, metallic taste, gagging, tight jaw) were reported across 10-20 participants. |
| For Mild OSA Reduction: | |
| Primary Endpoint: Reduction in AHI (Apnea-Hypopnea Index). | The mean reduction in AHI was (b)(4) and the relative reduction was about 48%. (Specific value is redacted) |
| Secondary Endpoint: Reduction in Oxygen Desaturation Index (ODI). | The mean change in ODI was (b)(4). (Specific value is redacted) |
| Secondary Endpoint: Change in oxygen saturation indices. | There was no significant improvement in mean oxygen saturations (b)(4) or percent of time spent at less than 90% oxygen saturation (b)(4). (Specific values are redacted) |
| Secondary Endpoint: Reduction in the Epworth Sleepiness Scale (ESS). | The mean change of ESS was (b)(4). (Specific value is redacted) |
| Secondary Endpoint: Reduction in the Pittsburg Sleep Index (PSQI). | The mean change of PSQI was (b)(4). (Specific value is redacted) |
| Secondary Endpoint: Assess safety (record and investigate adverse events, oral status and monitor device integrity). | No serious adverse events were noted. 10 participants of the mild OSA cohort experienced temporary adverse events (excessive salivation, tongue discomfort, tooth discomfort, tongue tingling, filling sensitivity, metallic taste, gagging, tight jaw). |
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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