(269 days)
Adjustable TheraSnore appliance is indicated for the treatment of snoring and mild to moderate obstructive 18 years of age or older.
The Adjustable Therasnore appliance of this submission ("Subject Device") is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults (OSA). The Subject Device consists of an upper and a lower tray. The trays snap together and lock by means of a locking mechanism. The upper and lower trays snap together by means of four interlocking mechanisms, or railways which allow 1.5 mm incremental adjustments in a forward and backward fashion. The lower tray can be advanced up to a maximum of 10 mm forward relative to the upper tray. The upper tray fits against the upper teeth and the lower tray fits against the lower teeth. The Subject Device when positioned on the teeth with the mandible in a forward position functions as a mandibular repositioner and acts to increase the patient's pharyngeal space which improves their ability to exchange air during sleep. The Subject Device is a boil and bite appliance consisting of an upper tray designed to fit over the teeth of the maxilla and a lower tray that fits to the lower incisors and prevents the tongue and mandible from falling back during sleep. The Subject Device is worn on the maxillary arch and covers the entire maxillary arch. Each tray is made from a hard acrylic material and a soft thermal plastic. The Subject Device is custom fitted for each patient by a doctor or dentist once the appliance is extracted from the heated water, cooled to the touch and the upper and lower trays are soft and pliable. This pliability allows the physician or dentist to fit the appliance to the upper and lower teeth of the patient when the patient pushes the mandible slightly forward into the appropriate position and the upper and lower tray are locked together. After this custom fitting, the Subject Device when in the patient's mouth, repositions the mandible in a slightly protruded forward position for as long as the Subject Device is worn. The appliance is provided to the patient on the same day of the fitting.
The provided text describes a 510(k) premarket notification for the "Adjustable Therasnore" device, an intraoral mandibular repositioning device for treating snoring and mild to moderate obstructive sleep apnea.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "RDI must decrease by X%" or "Oxygen saturation must improve by Y%"). Instead, it presents the results of a clinical evaluation to demonstrate the device's effectiveness.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Implicit: Device effectively treats snoring and mild to moderate OSA | - Significantly improved respiratory disturbance index (RDI) |
| - Improved oxygen saturation levels | |
| - Decrease in the duration of apneic events |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 43 patients
- Data Provenance: The document does not specify the country of origin. It appears to be a prospective clinical evaluation as it states "Clinical evaluation and observation in forty-three (43) patients... were treated with the Subject Device and showed..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number or qualifications of experts used to establish ground truth (e.g., to diagnose OSA or measure RDI/oxygen saturation). Sleep studies are typically interpreted by sleep specialists or pulmonologists, but this information is not detailed in the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the clinical evaluation.
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
There is no mention of an MRMC comparative effectiveness study or AI assistance. This study focuses on the device's direct therapeutic effect, not on diagnostic accuracy with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a physical medical device, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used appears to be objective physiological measurements related to sleep-disordered breathing:
- Respiratory Disturbance Index (RDI)
- Oxygen saturation levels
- Duration of apneic events
These measurements are typically derived from polysomnography (sleep study) data, which is an objective outcome, and likely interpreted by sleep specialists.
8. The sample size for the training set
The document does not mention any "training set." This type of device approval (510(k)) is based on substantial equivalence to a predicate device and clinical evaluation, not typically machine learning model training.
9. How the ground truth for the training set was established
As there is no mention of a training set, this question is not applicable.
§ 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.”