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VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum in the diagnosis and treatment of myocardial infarction. VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum. VITROS Cardiology Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of CK-MB.

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The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (VITROS Immunodiagnostic Products CK-MB Reagent Pack, Calibrators, and Controls). This type of document does not contain the detailed study information required to answer your questions about acceptance criteria, performance, sample sizes, ground truth establishment, or expert involvement.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring detailed de novo clinical study results in the same way a PMA (Premarket Approval) would. While the applicant would have submitted data to the FDA, that data isn't typically included in the public-facing clearance letter.

Therefore, I cannot provide the requested information from the given text. To get this data, you would typically need to refer to the 510(k) summary document (which often contains a condensed version of the performance data) or the full 510(k) submission itself, which is usually not publicly accessible in its entirety.

In summary, the provided document does not contain the information needed to fill out the requested table or answer the specific questions about the study design and results.

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