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for the semi-quantitative detection of IgG antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgG ELISA" device. This document is a regulatory approval letter and does not contain the detailed study information required to answer the questions comprehensively. It confirms the device's substantial equivalence to a predicate device and its intended use, but it does not describe the specific performance studies, acceptance criteria, or ground truth establishment in the level of detail requested.

Therefore, I cannot provide all the requested information from the given text. However, I can extract the following:

Device Name: INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgG ELISA

Indications For Use: For the semi-quantitative detection of IgG antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies, in conjunction with IgA antibodies, is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis. This test is intended for providing added sensitivity when testing IgA deficient patients.

To answer your questions, the relevant information would typically be found in the 510(k) submission summary or the study reports themselves, which are not included in this document.

Based on the provided text, I cannot answer the following questions:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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