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The Elecsys® SHBG CalCheck is intended for use in the verification of the calibration established by the Elecsys® SHBG reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys® SHBG CalCheck is a lyophilized product manufactured using SHBG in human serum/ horse serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.

The provided text describes a medical device called "Elecsys® SHBG CalCheck," a calibration verification material. However, the document does not contain specific acceptance criteria or a detailed study demonstrating how the device meets such criteria.

The text focuses on the 510(k) submission process, stating the device's intended use, its substantial equivalence to a predicate device, and the regulatory approval. It mentions that "Performance Characteristics" were evaluated for "value assignment and stability," but it does not provide the results of these evaluations or any numerical acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.

The provided text primarily serves as a regulatory approval document (510(k) summary and FDA clearance letter) and does not detail the technical performance study itself.

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