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This kit is intended for screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.

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The provided text is a U.S. FDA 510(k) clearance letter for the "Monkey Oesophagus IFA Kit." This document does not contain the detailed information required to describe acceptance criteria and the study proving the device meets them.

The letter is a regulatory approval document, stating that the device is substantially equivalent to legally marketed predicate devices. It confirms the device can be marketed. It does not include information about the performance evaluation study, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table and details based on the input text. The input is a clearance letter, not a device performance study report.

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