(483 days)
Indication for Use: To reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Target Population: Adult patients, over 18 years of age, with snoring and mild to moderate obstructive sleep apnea.
Environment of Use: Fitting of the mRNA appliance in the dental office for patient use at home.
The mRNA appliance is an intraoral device used for treating and mild to moderate sleep apnea, functioning as a mandibular repositioner and acting to increase the patient's pharyngeal space to improve the ability to exchange air. It consists of two customized trays that fit over the upper and lower teeth. An adjustment mechanism enables the device to be customized for each patient.
The mRNA appliance is a customized oral device featuring both lower (optional) and upper interlocking trays. These trays prevent the collapsing of the tissues in the back of the throat and preserves the airway.
The mRNA appliance consists of upper and lower interlocking, customized trays. The mRNA appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The mRNA appliance allows for interlocking of the upper and lower trays; the mandibular position may be adjusted antero-posteriorly (AP), transversely (TV), as well as permitting adjustments of the vertical dimension of occlusion (VDO). The interlocking of the upper and lower trays to permit adjustments in the vertical dimension is the primary unique feature of this design.
The provided text describes the mRNA appliance™, an intraoral device for treating snoring and mild to moderate obstructive sleep apnea. However, it explicitly states:
"No animal or clinical testing is included."
Therefore, there is no study described in the provided text that proves the device meets specific acceptance criteria based on clinical performance. The submission primarily focuses on establishing substantial equivalence to predicate devices through a comparison of design, function, mechanism of action, composition, risk analysis, and materials.
Here's a breakdown of the requested information based on the provided text, highlighting the absence of clinical study data:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable for clinical performance. The document does not define specific clinical acceptance criteria or report clinical performance data for the mRNA appliance™ itself, as no clinical testing was performed for this submission. The "reported device performance" referred to here is based on the substantial equivalence to predicate devices, which are known to be effective.
| Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|
| NA (No clinical performance criteria established for the mRNA appliance™ in this submission) | NA (No clinical performance reported for the mRNA appliance™ in this submission) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used for the mRNA appliance™ in this submission. The comparison was primarily conceptual and material-based against predicate devices, not involving patient data from the mRNA appliance™.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set was used for the mRNA appliance™ in this submission, so no experts were needed to establish ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used for the mRNA appliance™ in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "No animal or clinical testing is included." Therefore, no MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical intraoral appliance, not an algorithm or software. Therefore, the concept of "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for clinical performance. For the purpose of establishing substantial equivalence, the "ground truth" relied upon was the known efficacy and safety profiles of the predicate devices. This is based on previously established clinical outcomes data from the predicate devices, not new data generated for the mRNA appliance™.
8. The Sample Size for the Training Set
Not applicable. No training set was used for this submission, as no new clinical data was generated for the mRNA appliance™.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used, as no new clinical data was generated for the mRNA appliance™. The submission leverages the existing regulatory approval and clinical performance of predicate devices.
§ 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.”