(125 days)
The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.
The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be seep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.
This submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®
This document describes the SomnoDent® with Micro-Recorder, an oral appliance intended for the treatment of snoring and mild to moderate obstructive sleep apnea, with an optional embedded micro-recorder to measure patient compliance.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or reported device performance metrics in a readily extractable table for the SomnoDent® with Micro-Recorder itself.
Instead, the submission for the SomnoDent® with Micro-Recorder relies on demonstrating substantial equivalence to a previously cleared predicate device (SomnoDent® Fusion Classic and SomnoDent® Fusion Flex, K140278). The key argument is that the addition of the DentiTrac® micro-recorder does not change the intended use or safety/effectiveness of the SomnoDent device for treating sleep apnea and snoring.
The table in Section 7.0 ("Comparison to the Predicate") lists several "Technological Characteristics" and indicates whether both the predicate and proposed device possess these characteristics. This table serves as a comparison to show that the fundamental design and intended use of the SomnoDent device itself remain unchanged. The only difference highlighted is the presence of the DentiTrac® Micro-recorder in the proposed device.
| Technological Characteristics | Predicate SomnoDent® Fusion K140278 | Proposed SomnoDent® Family with DentiTrac® Micro-Recorder |
|---|---|---|
| Intended as an intraoral device | Yes | Yes |
| Intended to reduce snoring or help alleviate snoring | Yes | Yes |
| Treatment of mild to moderate obstructive sleep apnea | Yes | Yes |
| Intended for nighttime use | Yes | Yes |
| Indicated for single patient multiuse | Yes | Yes |
| Indicated for use at home or sleep laboratories | Yes | Yes |
| Target population: adults | Yes | Yes |
| Prescription device | Yes | Yes |
| Customized fit for each patient | Yes | Yes |
| Separate upper and lower tray pieces | Yes | Yes |
| Works by mandibular advancement | Yes | Yes |
| Can be adjusted or refit | Yes | Yes |
| Lower jaw adjustment using supplied components | Yes | Yes |
| Permits patient to breathe through mouth | Yes | Yes |
| Upper and lower trays disengage for easy removal | Yes | Yes |
| Cleaned and inspected daily by patient | Yes | Yes |
| Trays constructed from a soft lining material adhered to a hard surface acrylic | Yes (Flex retention) / No (Classic retention) | Yes (Flex retention) / No (Classic retention) |
| Advancement mechanism constructed of surgical grade stainless steel | Yes | Yes |
| DentiTrac® Micro-recorder embedded into SomnoDent® | No | Yes |
The section 8.0 Performance Testing states: "Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change." This indicates that no new clinical performance metrics or acceptance criteria for treatment effectiveness were established or evaluated for this 510(k) submission, as it is assumed to be equivalent to the predicate.
The performance testing mentioned focuses on the new component (DentiTrac® micro-recorder) and its integration:
- EMC and electrical safety
- Biocompatibility
- Software elements
- Process validation to ensure reliable embedding and retention of Quality Control functionality.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a traditional test set sample size in the context of clinical performance for the SomnoDent® with Micro-Recorder itself. The claim is substantial equivalence based on the predicate device's existing performance.
For the embedded DentiTrac® micro-recorder, the document refers to "Risk assessments and non-clinical testing." It mentions data being reported in "master file, MAF2557" which would presumably contain details on the testing of the micro-recorder's functionality, but the specifics of sample sizes or data provenance (country, retrospective/prospective) are not detailed in this 510(k) summary. Given the nature of these tests (EMC, electrical safety, biocompatibility, software, process validation), they typically involve testing of components or prototypes rather than large human subject cohorts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as no new clinical study to establish ground truth for treatment effectiveness was necessary for this submission. For the non-clinical testing of the micro-recorder, expert involvement (e.g., in risk assessment or evaluation of test results) is implied for the master file, but not explicitly detailed regarding number or qualifications.
4. Adjudication Method for the Test Set
This information is not provided as no clinical adjudication for a human subject test set is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. The device is a physical intraoral appliance with an optional compliance recorder, not an imaging or diagnostic AI requiring human reader interaction.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
For the SomnoDent® device itself (for treatment of sleep apnea/snoring), it's a physical device that a clinician fits and adjusts. There is no algorithm-only performance in the typical sense.
For the DentiTrac® micro-recorder, its function is to objectively measure wear time, movements, and head position. This is an objective data collection function. While it uses internal algorithms to process raw sensor data into meaningful metrics (like wear time based on oral temperature), the document does not describe a standalone performance study of these algorithms in terms of accuracy against a ground truth for wear time. It refers to "software elements were assessed and tested" and "Process validation was generated from SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®." This implies internal validation, but no external standalone study is detailed in this document.
7. Type of Ground Truth Used
For the SomnoDent® device's substantial equivalence, the "ground truth" for its effectiveness is implicitly the established effectiveness of the predicate device (K140278) which would have undergone its own clinical validation.
For the DentiTrac® micro-recorder, the "ground truth" for its compliance measurement function (wear time based on oral temperature, movement, head position) is not explicitly detailed in this document. It's likely that internal validation studies would have demonstrated the accuracy of its sensors and algorithms against known physical conditions or reference measurements, but these specifics are absent from the 510(k) summary.
8. Sample Size for the Training Set
This information is not applicable in the context of this 510(k) submission. The device is not an AI/ML algorithm that requires a separate training set. The DentiTrac® micro-recorder contains software, but it operates based on defined sensor input and algorithms, not machine learning models trained on large datasets in the way typical AI devices are.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.”