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The SomnoDent Avant 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 Avant device is an intraoral device used for treating Snoring and Sleep Apnea. 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 Avant is a modification to the SomnoDent Flex (K073004). The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range from -1.0mm to +8.0mm.

Here's an analysis of the provided text regarding the SomnoDent Avant device, focusing on acceptance criteria and the study proving it meets them.

The provided document is a 510(k) summary for the SomnoDent Avant, which primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study with human subjects to prove the device's performance against specific acceptance criteria for effectiveness (e.g., reduction in AHI, improved snoring). Instead, the performance evaluation relies heavily on bench testing and material conformance to show that the modified device (SomnoDent Avant) is as safe and effective as its predicate (SomnoDent Flex).

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) cannot be answered from the provided text, as such studies were not the basis for this 510(k) clearance.

Key takeaway: This 510(k) relies on demonstrating the new device is fundamentally similar to an already cleared device, not on new clinical performance data.

Acceptance Criteria and Device Performance (As Inferred from the 510(k) Summary)

Since a clinical performance study with acceptance criteria for clinical outcomes (e.g., AHI reduction) is not detailed, the "acceptance criteria" here are best characterized as design and material characteristics demonstrating substantial equivalence to the predicate, and bench test results confirming the safety and functional integrity of the modifications.

Study Details Proving Device Meets Acceptance Criteria

Given that this 510(k) relies on substantial equivalence and bench testing, direct answers to many of the typical clinical study questions are not available from the provided text.

1. Sample Size Used for Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" refers to materials or mechanical components undergoing bench testing. The specific number of samples for each bench test (biocompatibility, material conformance, adjustment mechanism) is not provided.
   • Data Provenance: The document does not specify a country of origin for the bench testing data. It mentions "Bench testing of the new adjustment mechanism and evaluation of the additional strap set material," implying laboratory testing. The studies were non-clinical (Summary of Non-Clinical Testing).

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

   • Not applicable. Ground truth for clinical performance was not established through expert consensus in this 510(k). The "ground truth" for material properties and functionality was established by adherence to specified ISO standards and validated test methods.

3. Adjudication Method for the Test Set:

   • Not applicable. This was not a human-reader study requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through design, materials, and non-clinical bench testing.

5. If a Standalone (Algorithm Only) Performance Study was done:

   • Not applicable. This device is a physical intraoral appliance, not an AI algorithm.

6. The Type of Ground Truth Used:

   • The "ground truth" for the acceptance criteria was based on established international standards (ISO) for biocompatibility, material properties, and risk management (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 20795-1, ISO 14971) and engineering principles for mechanical function. This is consistent with a 510(k) for a physical device demonstrating substantial equivalence.

7. The Sample Size for the Training Set:

   • Not applicable. No "training set" in the context of machine learning or AI models was used. The device is physically manufactured based on patient scans and a prescribed design.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as no training set was used.

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