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LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array® Protein Systems is intended for use as an assayed quality control material for analysis.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the LiniCAL™ Protein 2 Calibration Verifiers. It states that the device is substantially equivalent to legally marketed predicate devices and is intended for use as an assayed quality control material.

The text does not contain:

• A table of acceptance criteria or reported device performance.
• Details on sample sizes, data provenance, number of experts, their qualifications, or adjudication methods for test sets.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
• Details about the type of ground truth used or how ground truth for training sets was established.

Therefore, I cannot provide a response that includes the requested information based on the input given.

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