(205 days)
To reduce nighttime snoring and mild to moderate sleep apnea in adults.
The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.
The device is identical to the already-marketed mRNA appliance except the top and bottom trays interlock using the Herbst telescoping hinge instead of the mRNA flange. It is used in the predicate SomnoMed® device as well as many other devices in the market, e.g. Oasys Sleep (K181571) reference and Oasys Oral/Nasal Airway system (K030440). The mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device.
The provided document is a 510(k) summary for the mmRNA appliance, which is an intraoral device for snoring and mild to moderate sleep apnea. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Vivos Therapeutics mRNA Device, K130067).
However, the document does not contain a study that proves the device meets specific acceptance criteria. Instead, it relies on the argument of substantial equivalence to a predicate device, as permitted under the 510(k) pathway. This means that direct performance data from a clinical study for the subject device (mmRNA appliance) is generally not required if it can be demonstrated that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study results, expert involvement, and ground truth establishment are not available in this document for the subject device. The document focuses on demonstrating similarity to the predicate device.
Below is an attempt to address your request based on the information available in the document, highlighting what is not present.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence and General Claims)
As this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device that is already deemed safe and effective for the indicated use. The document does not provide specific quantitative acceptance criteria or a study with direct performance metrics for the mmRNA appliance itself. Instead, it makes claims about its function and similarity to the predicate.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Claims based on Predicate) |
|---|---|
| Mechanism of Action: Open the airway during sleep via mandibular advancement. | Mechanism of action is mandibular advancement, the same mechanism of action is used in the primary predicate device. (page 3) |
| Intended Use: Reduce nighttime snoring and mild to moderate sleep apnea in adults. | "To reduce nighttime snoring and mild to moderate sleep apnea in adults." (page 5) - Identical to primary predicate device. |
| Material Safety (Biocompatibility): Materials are safe for intraoral use. | "No additional biocompatibility testing is necessary, as the materials are use are identical to those of the predicate device." (page 5) |
| Mechanical Integrity: Device components are durable and functional. | "Mechanical Testing: The Somnodent predicate device, K130558, provided mechanical testing on the hinge. All other components are the same as the predicate mRNA." (page 5) - Relies on predicate hinge testing and component similarity. |
| Risk Profile: Risks (soreness, obstruction, tooth movement, breakage) are equivalent to predicate. | "A risk analysis was performed, which considered soreness, obstruction of breathing, tooth movement, and breakage. The product was compared to predicate devices in each area to show the risks were equivalent to the predicate devices." (page 5) |
Missing Information (Not provided in the document):
The following information is not available in the provided 510(k) summary because the document focuses on substantial equivalence rather than presenting a new clinical study for the subject device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for the subject device as no new clinical study data is presented for its performance. The document relies on the established performance of the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a medical device, not an AI or imaging diagnostic tool that would involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new performance study is presented. The "ground truth" for the predicate device's efficacy would have been established through its own clinical trials or prior regulatory clearances. The current document asserts the subject device functions similarly.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available regarding "the study that proves the device meets the acceptance criteria":
The document argues for substantial equivalence to the predicate device (Vivos Therapeutics mRNA Device, K130067), rather than presenting a new clinical study. The "proof" is based on:
- Similarity in Intended Use: Identical indications for use as the predicate device.
- Similarity in Mechanism of Action: Mandibular advancement, the same as the primary predicate device. The only difference is the specific hinge mechanism (Herbst hinge vs. flange).
- Similarity in Design and Materials: Customized acrylic trays with an expansion screw, optional extender, and standard dental materials (acrylic, stainless steel orthodontic wires).
- Reliance on Predicate Testing: Biocompatibility is assumed due to identical materials. Mechanical testing for the Herbst hinge is referenced from another predicate (SomnoMed® SomnoDent Herbst, K130558). A risk analysis concluded equivalence to predicates.
In conclusion, the document is a 510(k) submission that seeks clearance based on substantial equivalence to a predicate device, not on new clinical study data for the subject device itself. Therefore, detailed information about acceptance criteria met by a specific study is not provided for the mmRNA appliance but rather implied through its similarity to already cleared 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.”