(74 days)
The SomnoDent Herbst 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 Herbst 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 Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.
The provided text describes a 510(k) summary for the SomnoDent Herbst device. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device, rather than providing a detailed study that proves acceptance criteria for a novel device's performance.
Therefore, many of the requested items related to a comprehensive study (like specific acceptance criteria values, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not explicitly present in this type of regulatory submission. The document focuses on demonstrating that the new device (SomnoDent Herbst) is as safe and effective as previously cleared predicate devices through a comparison of design, intended use, and mechanical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific quantitative acceptance criteria with numerical targets are not provided in the document. This submission relies on demonstrating substantial equivalence to predicate devices rather than establishing new performance benchmarks.
The reported device performance is described qualitatively:
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Advancement Mechanism) | Withstand applicable pressures (implied from predicate devices) | "The mechanism withstands applicable pressures" |
| Safety and Effectiveness | As safe and effective as predicate devices | "ensuring the device is safe and effective." |
| Overall Performance (Compared to Predicate Devices) | Performs as well as or better than predicate devices | "performs as well as or better than the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The "mechanical testing" mentioned refers to tests performed on the device's mechanism itself, not a clinical trial with human subjects.
- Data Provenance: The mechanical testing was conducted on the "Herbst style titration mechanism of the subject device." No country of origin for data or retrospective/prospective nature is mentioned, as it's a verification test of the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. The "ground truth" for mechanical testing is typically based on engineering specifications and standards, not expert clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable and not provided. This relates to clinical studies with ambiguous outcomes, which is not the case for mechanical testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers interpreting medical images or data, which is not relevant for this device (an intraoral device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study was not done. This device is a physical intraoral device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For the mechanical testing, the ground truth is based on engineering specifications and performance requirements for medical devices of this type, ensuring the mechanism can withstand applicable pressures and function as intended. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms. It's a manufactured physical product.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not provided. As there is no training set for this type of device, no ground truth needed to be established in that context.
§ 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.”