(234 days)
The MICRODENTAL, Inc. MicrO2 device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together alleviate snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps or repositioning elastics. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device's 6mm advancement screw, measuring from plate to plate. This also negates the need for patients utilizing external controlling components such as keys, screwdrivers or ligature ties. The maximum protrusion of a MicrO2 archform is 6mm, which is comparable to the predicate device. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear. The Micr02 OSA device is identical to the Somnomed MAS RXA (Classic) except for the difference in the adjustment mechanism. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new safety concerns.
The provided text describes a 510(k) summary for the MicrO2 Obstructive Sleep Apnea Device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human participants to directly prove the device meets specific acceptance criteria related to its efficacy in reducing snoring or sleep apnea in patients.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be filled based on the provided text.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by performing "as well or better than the predicate device." The "reported device performance" is a qualitative assessment of "Yes" for improved or equal performance.
| Test Design | Acceptance Criteria (against predicate device) | Reported Device Performance (MicrO2 OSA) |
|---|---|---|
| AP Direction Fin Test | Equal or improved Mean Shear Strength (lbf) | Yes (Improved/Equal) |
| Lateral Direction Fin Test | Equal or improved Mean Shear Strength (lbf) | Yes (Improved/Equal) |
| Cross-Arch Compression Test | Equal or improved Mean Shear Strength (lbf) | Yes (Improved/Equal) |
| Leachability Test (ug/g) | Equal or improved leachability | Yes (Improved/Equal) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The testing described is bench testing, not clinical testing on a patient population.
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)
This information is not applicable as the provided text describes bench testing (mechanical and chemical property comparison), not a study requiring expert ground truth for clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the provided text describes bench testing.
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
This information is not applicable. The device is a physical intraoral device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical intraoral device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" was established by comparing the mechanical and chemical properties of the MicrO2 OSA device directly against those of the predicate device (Somnomed MAS RXA). The predicate device's established performance served as the benchmark.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning study. The document describes bench tests on physical devices.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.”