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The Panthera Occlusal Appliance is indicated for protections from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.

The Panthera Occlusal Appliance is a removable intraoral device used for protecting teeth and restorations against the forces of bruxism. It consists of patient-specific splint that fit over the upper or lower teeth. This device functions as a protective barrier for teeth and restorations by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (like grinding and clenching) and alleviating temporomandibular joint, jaw, and muscle and tension headache pains. There are various occlusal designs for this application, all with varying degrees of function and suitability depending on the patient's needs. The Panthera Occlusal Appliance is customized for each patient based on the clinician's prescription, and is to be worn every day during hours of sleep.

The provided text describes the 510(k) premarket notification for the Panthera Occlusal Appliance. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than proving the performance of a novel AI/software-driven medical device against specific acceptance criteria using a study.

Therefore, the information required to answer the prompt regarding AI/software performance, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in the provided document.

The document states:

• "Human clinical study was not deemed necessary to support substantial equivalence." (page 7)
• "The Panthera Occlusal Appliance does not use design dissimilar from the primary predicate and reference devices, does not use new technologies different from the primary predicate and reference devices, and does not deviate from the indications for use of the primary predicate and reference devices." (page 7)

This indicates that the submission relies on demonstrating that the new device is fundamentally similar in design, technology, and indications for use to existing, legally marketed devices (predicates and references). The "bench testing" mentioned (page 7) is for physical properties and intended use, not for AI/algorithm performance.

In summary, the provided document does not contain the information requested in the prompt, as it is a 510(k) for a physical dental appliance based on substantial equivalence, not an AI/software medical device requiring performance studies against specific acceptance criteria.

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The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.

The Narval Brux is a removable intraoral device used for protecting teeth and restorations aqainst the forces of bruxism. It consists of patient-specific splints that fit separately over the upper or lower teeth. The design of the splints is dependent on the patient needs.

The device functions as a protective barrier for teeth and restorations by creating physical separation between posterior occlusal surfaces and/or anterior incisal edges which will prevent tooth damage caused by grinding, bruxing and may help alleviate jaw and muscle pain.

The device is customized for each patient based on the clinician prescription.

The provided document is a 510(k) summary for the Narval Brux device, which is a mouthguard intended for the protection of teeth and restorations from bruxism.

The document does not describe a clinical study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/ML device would. Instead, this 510(k) submission establishes substantial equivalence to a predicate device (SomnoBrux Splint(s), K102909) through non-clinical testing.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from this document.

Here's an attempt to answer the questions based on the provided information, noting where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

For the Narval Brux, the acceptance criteria are not presented as quantitative performance metrics (e.g., sensitivity, specificity) but rather as successful completion of non-clinical tests ensuring comparable safety and efficacy to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable in the context of this 510(k) submission, as no human clinical test set (like an AI/ML model's test set) was used. The submission focuses on non-clinical engineering and material tests.
• Data Provenance: Not specified for the non-clinical tests. Non-clinical data typically refers to laboratory or bench testing.

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)

• Not applicable. Ground truth, in the AI/ML context, is not relevant for this type of non-clinical device submission. The "ground truth" here would be the validated performance of the materials and design against engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no test set requiring expert adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or assistive technologies, not for a physical medical device like a mouthguard, especially when establishing substantial equivalence via non-clinical data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" or basis for evaluation in this submission stems from established engineering standards, material safety standards (ISO 10993 for biocompatibility), and performance test methodologies (static compression) for mouthguards. The substantial equivalence argument relies on the new device performing equivalently to the predicate device in these non-clinical aspects.

8. The sample size for the training set

• Not applicable. There is no AI/ML training set mentioned in this document.

9. How the ground truth for the training set was established

• Not applicable. There is no AI/ML training set described.

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