(98 days)
The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).
The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
The provided document is a 510(k) Premarket Notification for the SomnoMed MAS Flex "S" device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense for algorithm performance.
Here's an analysis based on the information provided and how it relates to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Comparison) |
|---|---|
| Indications for Use: | Indications for Use: |
| - Treatment of Snoring in Adults | - Yes (Matches all predicate devices) |
| - Treatment of mild to moderate Obstructive Sleep Apnea | - Yes (Matches all predicate devices) |
| Operational Use: | Operational Use: |
| - Intra oral device for overnight use | - Yes (Matches all predicate devices) |
| - Single patient multi use | - Yes (Matches all predicate devices) |
| - Use at home or at a Sleep Laboratory | - Yes (Matches all predicate devices) |
| - Prescription Device | - Yes (Matches all predicate devices) |
| Action Mechanism: | Action Mechanism: |
| - Works by mandibular advancement | - Yes (Matches all predicate devices) |
| Design Characteristics: | Design Characteristics: |
| - Custom fit for each patient | - Yes (Matches all predicate devices) |
| - Rigid separate upper and lower tray pieces | - Yes (Matches all predicate devices) |
| - Can be adjusted or refit | - Yes (Matches all predicate devices) |
| - Lower jaw adjustment using a supplied adjustment key | - Yes (Matches all predicate devices) |
| - Cleaned and inspected daily | - Yes (Matches all predicate devices) |
| - Permits patient to breathe through the mouth | - Yes (Matches all predicate devices) |
| - Upper and lower trays disengage for easy removal from mouth | - Yes (Matches all predicate devices) |
| Materials: | Materials: |
| - Safe and effective for intended use | - Trays constructed from a soft lining material adhered to a hard surface acrylic. This is the primary difference from the original SomnoMed MAS, but the document states "This difference does not have significant effect on the safety or effectiveness of the SomnoMed MAS Flex "S"." Bench testing confirmed material biocompatibility and product strength. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
There is no test set sample size mentioned as this document does not describe a clinical study comparing the device's efficacy in a patient population against a gold standard for snoring or sleep apnea reduction. The submission is focused on material changes and confirming safety/equivalence through bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There was no human expert evaluation of a test set for clinical performance mentioned. The ground truth, in the context of a 510(k) for a modified device, is primarily the established safety and effectiveness of the predicate device for its intended use, and the demonstration that the material change does not negatively impact this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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 medical device (intra-oral appliance), not an AI algorithm, and therefore an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and effectiveness of the predicate device (SomnoMed MAS K020592) for treating snoring and mild to moderate obstructive sleep apnea, combined with bench testing data (biocompatibility, product strength) on the new material to demonstrate it does not compromise these aspects.
8. The sample size for the training set
Not applicable. This is a physical device and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical device and does not involve a training set for an algorithm.
In summary:
This 510(k) notification is for a modification to an existing physical medical device, primarily involving a change in catch material. The "study" referenced is bench testing to confirm the new material's biocompatibility and product strength, and a comparison table to demonstrate that the new device retains all functional attributes and indications for use of the predicate device. The primary "proof" is the demonstration of substantial equivalence to an already legally marketed device, not a new clinical efficacy trial for the device's therapeutic effect.
§ 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.”