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Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.

Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.

I am sorry, but the provided text is a 510(k) summary for a medical device called "Qualicheck™4 Metabolite," which is a quality control system.

This document describes the intended use of the device (checking precision and accuracy of analyzers) and states its technological characteristics are similar to a predicate device (Qualicheck 4 Glucose). It asserts substantial equivalence based on these similarities, with the only difference being the addition of the lactate analyte.

However, the summary does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, or AI-related comparative effectiveness studies. These elements are typically found in detailed study reports or clinical validation sections of a 510(k) submission, not in the summary document provided.

Therefore, I cannot fulfill your request for the tables and information related to acceptance criteria and device performance studies based on the input text.

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