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The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices 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 devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be seep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®

This document describes the SomnoDent® with Micro-Recorder, an oral appliance intended for the treatment of snoring and mild to moderate obstructive sleep apnea, with an optional embedded micro-recorder to measure patient compliance.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or reported device performance metrics in a readily extractable table for the SomnoDent® with Micro-Recorder itself.

Instead, the submission for the SomnoDent® with Micro-Recorder relies on demonstrating substantial equivalence to a previously cleared predicate device (SomnoDent® Fusion Classic and SomnoDent® Fusion Flex, K140278). The key argument is that the addition of the DentiTrac® micro-recorder does not change the intended use or safety/effectiveness of the SomnoDent device for treating sleep apnea and snoring.

The table in Section 7.0 ("Comparison to the Predicate") lists several "Technological Characteristics" and indicates whether both the predicate and proposed device possess these characteristics. This table serves as a comparison to show that the fundamental design and intended use of the SomnoDent device itself remain unchanged. The only difference highlighted is the presence of the DentiTrac® Micro-recorder in the proposed device.

The section 8.0 Performance Testing states: "Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change." This indicates that no new clinical performance metrics or acceptance criteria for treatment effectiveness were established or evaluated for this 510(k) submission, as it is assumed to be equivalent to the predicate.

The performance testing mentioned focuses on the new component (DentiTrac® micro-recorder) and its integration:

• EMC and electrical safety
• Biocompatibility
• Software elements
• Process validation to ensure reliable embedding and retention of Quality Control functionality.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a traditional test set sample size in the context of clinical performance for the SomnoDent® with Micro-Recorder itself. The claim is substantial equivalence based on the predicate device's existing performance.

For the embedded DentiTrac® micro-recorder, the document refers to "Risk assessments and non-clinical testing." It mentions data being reported in "master file, MAF2557" which would presumably contain details on the testing of the micro-recorder's functionality, but the specifics of sample sizes or data provenance (country, retrospective/prospective) are not detailed in this 510(k) summary. Given the nature of these tests (EMC, electrical safety, biocompatibility, software, process validation), they typically involve testing of components or prototypes rather than large human subject cohorts.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as no new clinical study to establish ground truth for treatment effectiveness was necessary for this submission. For the non-clinical testing of the micro-recorder, expert involvement (e.g., in risk assessment or evaluation of test results) is implied for the master file, but not explicitly detailed regarding number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided as no clinical adjudication for a human subject test set is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The device is a physical intraoral appliance with an optional compliance recorder, not an imaging or diagnostic AI requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

For the SomnoDent® device itself (for treatment of sleep apnea/snoring), it's a physical device that a clinician fits and adjusts. There is no algorithm-only performance in the typical sense.

For the DentiTrac® micro-recorder, its function is to objectively measure wear time, movements, and head position. This is an objective data collection function. While it uses internal algorithms to process raw sensor data into meaningful metrics (like wear time based on oral temperature), the document does not describe a standalone performance study of these algorithms in terms of accuracy against a ground truth for wear time. It refers to "software elements were assessed and tested" and "Process validation was generated from SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®." This implies internal validation, but no external standalone study is detailed in this document.

7. Type of Ground Truth Used

For the SomnoDent® device's substantial equivalence, the "ground truth" for its effectiveness is implicitly the established effectiveness of the predicate device (K140278) which would have undergone its own clinical validation.

For the DentiTrac® micro-recorder, the "ground truth" for its compliance measurement function (wear time based on oral temperature, movement, head position) is not explicitly detailed in this document. It's likely that internal validation studies would have demonstrated the accuracy of its sensors and algorithms against known physical conditions or reference measurements, but these specifics are absent from the 510(k) summary.

8. Sample Size for the Training Set

This information is not applicable in the context of this 510(k) submission. The device is not an AI/ML algorithm that requires a separate training set. The DentiTrac® micro-recorder contains software, but it operates based on defined sensor input and algorithms, not machine learning models trained on large datasets in the way typical AI devices are.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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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:

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.

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