(87 days)
Snore-Aid®plus is a perscribed anti-snoring device.
Snore-Aid®plus is indicated for use in patients with primary snoring A. or snoring and mild OSA (obstructive sleep apnea) where mandibular advancement and elevation of the tongue can increase a patient' s pharyngeal air space.
Snore-Aid®ø/us is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.
Snore-Aid@plus is a single plate mandibular advancement and tongue positioning orthotic consisting of: (1) a flat mandibular occlusal bite plate, (2) an adjustable external maxillary lip shield, and (3) a wide occlusal surface. The occlusal bite plate provides dental stability, protects the TMJ from occlusal loading and prevents muscle soreness due It also actively elevates and positions the tongue anteriorly to bruxism. and dorsally against the palate, thereby increasing the patency of the airway.
This 510(k) summary describes the Snore-Aid®plus device, an orthotic designed to treat snoring and mild obstructive sleep apnea (OSA) by advancing the mandible and positioning the tongue.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Snore-Aid®plus device were implicitly based on achieving a significant reduction in the Respiratory Disturbance Index (RDI) for patients with snoring and OSA. The study defined 'treatment success' as a 50% reduction in RDI and a post-treatment RDI ≤ 10.
| Acceptance Criteria Definition | Reported Device Performance |
|---|---|
| Treatment success: 50% reduction in RDI AND post-treatment RDI ≤ 10 | For RDI ≤ 30 patients (n=18): 100% (18 out of 18 patients) achieved treatment success. |
| For RDI > 30 patients (n=7): All 7 achieved a reduction in RDI below the pretreatment index, but only 1 achieved a post-treatment RDI ≤ 10. | |
| Absence of TMJ pain or muscle soreness | None of the subjects reported TMJ pain or muscle soreness. |
| Absence of bite changes upon awakening | None of the subjects reported bite changes upon awakening from sleep. |
| Absence of significant adverse events | Two patients reported nocturnal bruxism which caused temporary soreness of incisor teeth (considered minor compared to primary outcomes). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 25 subjects.
- Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The country of origin is not specified but is presumed to be the USA given the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications who diagnosed the snoring and OSA conditions. However, it mentions that subjects "were diagnosed with snoring and mild to severe OSA," implying a clinical diagnosis by qualified medical professionals (e.g., sleep specialists, pulmonologists). The polysomnography was read and interpreted by healthcare professionals skilled in sleep medicine.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1, 3+1, or similar. The "12 channel polysomnography" suggests objective data collection, which typically relies on established scoring rules rather than subjective adjucation for raw data. The diagnosis of OSA and RDI calculation would follow recognized clinical guidelines.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This study focuses on the device's efficacy when used by patients.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical, prescribed medical device (orthotic), not an algorithm or AI. Therefore, the concept of an "algorithm only" or "standalone" performance study, as typically applied to AI/software, is not applicable here. The study assesses the device's effectiveness in patients.
7. Type of Ground Truth Used
The ground truth for the test set was established through clinical diagnosis and objective physiological measurements.
- Diagnosis: Subjects were diagnosed with snoring and mild to severe OSA.
- Outcome Measurement: 12-channel polysomnography (PSG) was used for full-night sleep studies, providing objective data (e.g., RDI, apnea-hypopnea index) to assess the severity of OSA and the effectiveness of the treatment.
8. Sample Size for the Training Set
This document describes a clinical study on the device's efficacy, not the development of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The 25 subjects constitute the clinical study population used to evaluate the device.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no training set in the AI/ML sense. The ground truth for the clinical study was established by diagnosing patients with snoring and OSA and then using pre- and post-treatment 12-channel polysomnography to objectively measure the RDI and other sleep-related parameters.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”