(459 days)
Overnight use of a temporary oral appliance to determine in which patients with obstructive sleep apnea mandibular advancement by an oral appliance will reduce obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. The device is also used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.
The RCMP appliance is a device used in the clinical setting to identify patients with obstructive sleep apnea that will be successfully treated with an oral appliance. A temporary appliance fits to the patient's teeth and incrementally and reversibly advances the patient's mandible anteriorly with respect to the maxilla while the patient is under full polysomnographic monitoring. The repositioning of the mandible pulls the tongue forward and increases the patient's airway space. Such obstruction can be a causative factor in obstructive sleep apnea and snoring. The RCMP is used in the clinical setting by a technician to advance the mandible until the polysomnographic data indicates removal of the obstruction of airflow in the airway. The device is used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.
The RCMP appliance consists of upper and lower disposable dental titration trays that are used to hold onto the teeth by means of a quick-set retention material. The trays attach to a mandibular positioner that retracts and extends a rod to adjust the tray positioning by means of a small force linear actuator. By extending the linear actuator rod attached to the upper tray, the RCMP pushes on the upper teeth and pulls on the lower teeth, thus displacing the jaw. RCMP software interacts with the polysomnography to allow the technician to control fine adjustments of the relative position of the mandible.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for the device beyond demonstrating that it is "at least as safe and effective as the predicate device at selecting candidates for oral appliance therapy." It highlights performance characteristics and differences from the predicate without setting specific numerical targets.
However, based on the qualitative descriptions and the overall goal of the study, we can infer some implied performance objectives:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety: Device operation does not cause patient harm. | The validation study provides evidence that the RCMP test, when implemented in a polysomnographic setting by a trained sleep technician, is safe. |
| Patient Comfort/Procedure Tolerability: Procedure is comfortable. | The dental titration procedure and approach was shown to be comfortable for the patient. |
| Technician/Expert User-Friendliness: Easy for users to operate. | The dental titration procedure and approach was shown to be user friendly to both the technician and the sleep expert. |
| Non-Disruptive during Sleep Study: Device does not wake patient. | The study included a detailed arousal analysis that demonstrated that the RCMP sleep titration does not wake the patient and therefore the titration can be completed during REM sleep. |
| Effectiveness in Candidate Selection: Accurately identifies suitable patients for oral appliance therapy. | The study demonstrated that using prospectively determined criteria, the RCMP test can accurately select favorable candidates for oral appliance therapy. The study also demonstrated that the RCMP test can recommend a therapeutically effective target protrusive distance for the therapy. The clinical study demonstrated that the RCMP is at least as safe and effective as the predicate device at selecting candidates for oral appliance therapy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 66 patients.
- Data Provenance: The study was a prospective clinical study. Patients were recruited from a sleep center and dentist.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
The document mentions that:
- The RCMP is used "by a trained sleep technician".
- "The final assessment and recommendation for treatment by an appliance is completed by a physician who reviews the positioning data and associated cardio-respiratory reaction."
- The procedure was "user friendly to both the technician and the sleep expert."
While it confirms the involvement of a trained sleep technician for device operation and a physician (sleep expert) for final assessment and recommendation, it does not specify the exact number of physicians/sleep experts used to establish the ground truth (i.e., assess the suitability for oral appliance therapy and optimal mandibular position for each patient in the test set). It implies at least one physician. The qualifications are broadly described as "physician" and "sleep expert."
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for establishing ground truth from multiple experts. It states that "the final assessment and recommendation for treatment by an appliance is completed by a physician who reviews the positioning data and associated cardio-respiratory reaction." This suggests a single physician's review is part of the process for determining the "therapeutically effective target protrusive distance" and identifying suitable patients, rather than a multi-expert adjudication of the ground truth itself based on labels provided by independent readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study focused on demonstrating the safety and effectiveness of the RCMP device itself, particularly its ability to identify suitable candidates and recommend an effective mandibular position, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This device (RCMP) is not an AI algorithm but a physical, remotely controlled mechanical device. Its operation is explicitly stated to involve a "trained technician" and "physician" in a clinical setting. Therefore, a standalone (algorithm only) performance assessment is not applicable and was not performed. The device requires human interaction for its use and interpretation of its outputs.
7. The Type of Ground Truth Used
The ground truth used was based on polysomnographic data reviewed by a physician/sleep expert. Specifically, the device is used "in the clinical setting under full polysomnographic cardio-respiratory monitoring" to identify patients and then a "physician... reviews the positioning data and associated cardio-respiratory reaction" to make the final assessment and recommendation for treatment. This combines objective physiological measurements (polysomnography) with expert clinical judgment.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The clinical study described is a 66-patient validation study. Given that the RCMP is a device with mechanical and software components rather than a machine learning model, a distinct "training set" in the context of AI/ML is not relevant here. The device's design, software, and operational parameters would have been developed and tested through bench and engineering processes, not via a machine learning training dataset.
9. How the Ground Truth for the Training Set was Established
As no training set (in the ML sense) is mentioned, this question is not applicable. The device's functionality and efficacy were validated through the clinical study and bench testing, as opposed to being "trained" on a dataset.
§ 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.”