(27 days)
The SomnoDent G2 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 G2 device 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 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 G2 is a modification to the SomnoDent Flex (K073004). The SomnoDent G2 is identical to SomnoDent Flex, except for differences in the adjustment mechanism (which is an addition of a material of construction, which is biocompatible), and a change (which to an addition of a differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
The SomnoDent G2 is an intraoral device for treating snoring and mild to moderate obstructive sleep apnea. The provided text, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device (SomnoDent Flex, K073004) rather than presenting a study demonstrating its performance against specific acceptance criteria for efficacy in patients. Therefore, the device performance is primarily assessed through comparison to the predicate.
Here's an analysis of the information, acknowledging that the primary "study" is a comparative bench testing study to establish substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focused on substantial equivalence through bench testing rather than clinical efficacy, the "acceptance criteria" discussed are largely related to mechanical performance and safety, and the "reported device performance" is framed in terms of equivalence to the predicate.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Device functions as intended (mandibular repositioner, increases pharyngeal space) | The SomnoDent G2 and predicate device function as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. |
| Withstands mechanical forces (simulated bruxism) and functions as designed | Bench testing included a mechanical force test to simulate bruxism, which was effective and determined worst-case use. The results indicated that the subject device performs as well or better than the predicate device. |
| Winglet bond withstands applicable pressures | Mechanical testing was conducted on the winglet bond of the subject device. Testing results indicate that the bonds withstand applicable pressures, ensuring the device is safe and effective. |
| Mechanical performance of the advancement mechanism is equivalent to predicate | Comparative testing around the coupling mechanism was conducted. The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. |
| Modifications do not introduce new safety issues | The document explicitly states that "Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues." This is the overarching acceptance criterion addressed by the mechanical testing. |
| Biocompatibility of new material (polycarbonate) | The new material for the advancement mechanism is described as "biocompatible, medical grade polycarbonate." This implies that it meets acceptance criteria for biocompatibility, though no specific test results are detailed in this summary beyond the statement. |
| Adjustable range functionality | The device has an adjustable range from 6 to 10mm (compared to the predicate's 6mm, though the text states "a change in adjustable range from 6 to 10mm" where the predicate device might not have been 10mm, leaving slight ambiguity, but the G2 confirms 6-10mm capability). This functionality is stated as present. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices or units tested for the bench tests. It refers generally to "the subject device" and "the predicate device," suggesting testing was performed on representative units.
- Data Provenance: Not applicable in the traditional sense of patient data. The data is from laboratory bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is not applicable to this type of submission. The ground truth for mechanical and safety tests is established by engineering standards and validated testing protocols, not expert clinical consensus on patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Bench testing results are typically objectively measured and evaluated against predefined engineering specifications, not adjudicated by a panel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This is not a study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth for the bench testing was engineering specifications and mechanical performance standards. For comparison purposes, the performance of the legally marketed predicate device (SomnoDent Flex) served as a benchmark for equivalence. Biocompatibility standards would also serve as ground truth for material selection.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.”