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A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

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The provided text is an FDA 510(k) clearance letter for the "Olympus LDL Cholesterol Reagent & Calibrator." It describes the regulatory aspects of the device and its intended use. However, it does not contain any information about the acceptance criteria, specific performance studies, sample sizes, ground truth establishment, or expert involvement that would be needed to answer the user's request.

Therefore, I cannot provide the requested table or answer the specific questions based on the provided document. The document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than detailed performance study results.

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