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IMMULITE® 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.

IMMULITE® 2000 Anti-TG Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer

The provided text is a 510(k) Summary Safety and Effectiveness for the IMMULITE® 2000 Anti-TG Ab, a reagent system for measuring autoantibodies to thyroglobulin (TG). This document is a regulatory submission for a medical device and thus does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it contain information about AI or machine learning models.

The document states that the Food and Drug Administration (FDA) used the presented data in granting substantial equivalence to the predicate device. However, the actual performance data (e.g., sensitivity, specificity, accuracy) is not included in this summary.

Therefore, I cannot fulfill your request for the tables and other details regarding acceptance criteria, study design, and AI-specific information. The text does not provide this level of detail about the device's performance or the studies that would typically be conducted for such a purpose.

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