(137 days)
The SomnoDent Fusion is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.
The SomnoDent Fusion is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is patient specific (it is customized for each patient) and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: SomnoDent Fusion (an intraoral device for snoring and mild to moderate obstructive sleep apnea)
1. A table of acceptance criteria and the reported device performance
Based on the provided document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through mechanical testing. The performance is reported as meeting this equivalence.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Withstand applicable pressures (mechanical performance) | Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. |
| Substantial equivalence to predicate device in mechanical performance | The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. |
2. Sample size used for the test set and the data provenance
The document states: "Mechanical testing was conducted on the calibration mechanism of the subject device." However, it does not specify the sample size for this mechanical testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of this testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document as the study described is mechanical testing, not a clinical study involving human assessment or ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the described study is mechanical testing, not a clinical study involving human judgment or 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The SomnoDent Fusion is a physical intraoral device, not an AI or imaging diagnostic tool that would be evaluated with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test in the context of an algorithm or AI was not performed, nor is it applicable to this device. The device is a physical intraoral appliance. The "standalone" performance described is the mechanical testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established based on the predicate devices. The document implies that the "truth" is the "applicable pressures" and successful functioning compared to the predicate.
8. The sample size for the training set
This information is not applicable as the described study is mechanical testing for substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
§ 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.”