(438 days)
The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
The SomnoBrux Splints are intraoral devices used for treating bruxism. They consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.
The provided text is a 510(k) summary for the SomnoBrux Splints. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria in the way typically found for AI/ML devices.
The entire summary focuses on establishing substantial equivalence to previously cleared devices based on comparative analysis of features, materials, and design, rather than quantitative performance metrics for the SomnoBrux Splints themselves.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the SomnoBrux Splints. The conclusion of substantial equivalence is based on a qualitative comparison of design and function with predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or clinical study data is mentioned in relation to proving the performance of the SomnoBrux Splints. The submission relies on design and functional similarity to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. The device is a physical intraoral splint, not an AI/ML algorithm. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is established for the SomnoBrux Splints' performance in the context of a study. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices based on their design and intended use.
8. The sample size for the training set:
- Cannot be provided. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable to this type of device submission.
Summary of available information regarding substantial equivalence criteria (not "acceptance criteria" in the AI/ML sense):
The document states that the SomnoBrux Splints are substantially equivalent to the predicate devices (MYOHEALTH CLENCHING INHIBITOR and DSG Relaxer Splint) based on a "comparative analysis of features, materials and design."
- Key comparison points for substantial equivalence:
- All are custom manufactured.
- All are all acrylic type devices.
- All treat bruxism by relaxing the structure of the masticatory system.
- All cover posterior occlusal surfaces (with one predicate also covering maxillary six anterior teeth).
- Conclusion: "Any minor design differences between these various models do not affect safety and performance."
This indicates that the "acceptance criteria" for the 510(k) clearance was predominantly a qualitative assessment of functional and material similarity to legally marketed predicate devices, rather than quantitative performance benchmarks demonstrated through a specific study.
N/A