(204 days)
A patient specific mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
The Fuselier Intraoral Nighttime Device (FIND) is a patient specific oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The function of the FIND is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep.
The principle of advancing a lower tray is to advance the mandible for the treatment of night-time snoring and / or mild to moderate obstructive sleep apnea.
The information provided describes the Fuselier Intraoral Nighttime Device (FIND), which is intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients. The submission aims to demonstrate substantial equivalence to a predicate device, the Thornton Oral Appliance (TOA) (K972061).
Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed as numerical thresholds for clinical performance but are implied through the comparison to the predicate device. The performance is assessed by demonstrating similar characteristics and comparable mechanical properties.
| Acceptance Criteria / Characteristic | Reported Device Performance (FIND) | Predicate Device Performance (TOA - K972061) or Reference Data |
|---|---|---|
| Indications for Use | Reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older. | Reduce or alleviate nighttime snoring and obstructive sleep apnea, OSA. (Similar) |
| Environment of Use | Home, dental and Physician offices, Sleep laboratories | Home, dental and Physician offices, Sleep laboratories (Identical) |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older (Identical) |
| Contraindications | Central sleep apnea, severe respiratory disorders, loose teeth or advanced periodontal disease, under 18 years of age. | Central sleep apnea, severe respiratory disorders, loose teeth or advanced periodontal disease, under 18 years of age. (Similar) |
| Prescription Status | Prescription use | Prescription use (Identical) |
| Single patient, multi-use | Yes | Yes (Identical) |
| Principle of Operation | Adjustment of trays by an adjustable post to hold mandible forward, enlarging the airway. Vertical opening not fixed. | Adjustment of trays by a hook to pull mandible forward, enlarging the airway. Vertical opening not fixed. (Similar, different mechanism but same principle) |
| Patient Specific Trays | Yes | Yes (Identical) |
| Lateral and Vertical Movement | Allows lateral and vertical movement | Allows lateral and vertical movement (Identical) |
| Mouth Breathing | User can breathe through their mouth | User can breathe through their mouth (Identical) |
| Maximum Adjustment (user) | 8 mm | 8 mm (Identical) |
| Adjustment Method | Adjustable screw/post holds lower tray forward. | Hook pulls the lower tray forward. (Different mechanism) |
| Jaw Holding Mechanism | Works by holding lower jaw forward | Works by holding lower jaw forward (Identical) |
| Cleaning Method | Simple rinsing with water and toothbrush | Simple rinsing with water and toothbrush (Identical) |
| Materials/Biocompatibility | Surface contact: Mucosal, Prolonged duration, materials identical to K896130 (Ivocap Polymer) and K090436 (Airwayease MAS). | Surface contact: Mucosal, Prolonged duration, standard dental tray material. |
| Flexural Strength | Angle of deflection – 0.85 degrees | Angle of deflection - 1.25 degrees |
| Breakage Strength | 77 lbs. to damage | 70 lbs. to damage |
| Cleaning & Effects of Aging | No degradation after 1 year real-time use in private clinical practice with 150 patients. | Data not available (for predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Performance: The sample size for the mechanical performance testing (flexural and breakage strength) is not explicitly stated in terms of number of devices tested for either the FIND or the predicate. The text states "We performed flexural and breakage strength testing on the subject device and the predicate."
- Real-time Aging: The sample size for this observation was 150 patients who used the FIND in a private dental practice for over 1 year. This is retrospective observational data from a private dental practice. The country of origin is not specified, but given the FDA submission, it is likely U.S.-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts establishing ground truth in the context of the performance testing as described. The clinical observation for real-time aging was conducted in a "private dental practice," implying observation by dental professionals, but specific qualifications are not provided. The study focuses on mechanical equivalence and non-clinical performance, not a clinical efficacy study with ground truth established by experts in sleep medicine.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical study described that involved expert adjudication of outcomes. The testing primarily involved mechanical property comparison.
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. This device is a physical intraoral appliance, not an AI software or imaging interpretation tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the mechanical performance tests, the "ground truth" was the measured physical properties (angle of deflection, force to damage) of the devices themselves, compared against each other, presumably using standard engineering test methods.
- For the real-time aging observation, the ground truth was the observation of "no device failures" and the maintenance of "mechanical and durability" over 1 year, as reported from the private clinical practice experience. This is essentially observational outcomes data related to device integrity.
- There was no clinical efficacy study for the FIND; therefore, ground truth related to clinical outcomes like AHI reduction or snoring alleviation (e.g., from polysomnography) was not part of this submission for the new device. The substantial equivalence relies on the predicate's established effectiveness.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
§ 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.”