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The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.

ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.

I am sorry, but the provided text from the FDA 510(k) letter for the ESG-1 Electrosonogram (K970116) does not contain information regarding acceptance criteria, the study that proves the device meets acceptance criteria, or the specific details you requested about such a study.

This document is primarily concerned with the FDA's determination of substantial equivalence to a predicate device, allowing the ESG-1 Electrosonogram to be marketed subject to general controls. It references the device's indications for use and classification, but it does not delve into the detailed performance data or study specifics that would be part of a submission to demonstrate acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details on MRMC or standalone studies, or how ground truth was established, as this information is not present in the provided text.

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