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Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3". It acknowledges that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, the provided text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It is a regulatory approval document, not a performance study report.

Therefore, I cannot provide the requested information based on the input text. The elements you asked for (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are typically found in a clinical study report or a technical performance document, which this is not.

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