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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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