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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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The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System.

The Prosomnus [CA] Sleep and Snore device consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep. providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the Prosomnus [CA] Sleep and Snore device series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions up to 11mm to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The Prosomnus [CA] Sleep and Snore device twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

This submission adds the option for an embedded screw that allows for smaller discreet movements of the mandible in between the lower arch advancements. The inclusion of the embedded screw does not change the intended use, impact the operating principles nor impact the fundamental scientific principles of the device as established by the predicate device K133683, the MicrO2 OSA device. The same principles of operation to move the mandible forward are used to increase pharyngeal space and maximize the tongue space.

The Prosomnus [CA] Sleep and Snore device includes an optional Micro-recorder to monitor patient compliance.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in relation to an AI algorithm or its effectiveness in reducing snoring and sleep apnea.

The document is a 510(k) premarket notification for the Prosomnus [CA] Sleep and Snore Device and the Prosomnus [CA] Sleep and Snore Device with Micro-recorder. The purpose of this notification is to demonstrate substantial equivalence to previously cleared predicate devices, not to prove direct clinical efficacy or performance against defined acceptance criteria in a clinical study.

The "Substantial Equivalence" sections (pages 5 and 9) describe the basis for deeming the devices substantially equivalent to their predicates. This equivalence is primarily based on:

• Identical Indications for Use: Both the predicate and the subject devices are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Technological Characteristics: The operating principles, materials, manufacturing process (digital milling), and mechanism to move the mandible forward are considered similar.
• In Vitro Testing: The document mentions "Compression and Shear Torsion Testing" and "Package and Distribution Testing" as data relied upon to determine substantial equivalence. These are mechanical and packaging tests, not clinical performance studies related to snoring or OSA reduction.

Therefore, I cannot provide the requested information as it is not present in the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance for clinical outcomes.
2. Sample size for a test set for clinical performance or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for clinical efficacy (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "studies" mentioned are in vitro technical tests for mechanical integrity and packaging, not clinical performance studies in humans.

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