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• To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
• To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
• To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

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While the provided text refers to the FDA's substantial equivalence determination for the TEETHAN 2.0 device, it does not contain the specific details regarding acceptance criteria, study design, or performance metrics that you've requested.

The document is primarily an FDA 510(k) clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines general regulatory requirements and indications for use, but it does not include the technical study results or the detailed information about the validation process (like sample size, ground truth establishment, expert qualifications, etc.).

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different document, such as the full 510(k) summary, clinical study reports, or a more detailed technical submission from the manufacturer to the FDA.

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