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Glucose Drink is a flavored beverage containing specific amounts of dextrose (D-glucose). Manufactured beverages contain three different amounts of glucose; 50,75, and 100 grams quantities per 10 oz bottle. This product is consumed in the In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and other related illnesses.

Glucose Drink is a water-based non-carbonated flavored beverage containing specific quantities of dextrose. We are marketing three flavors; orange, fruit punch, and lemonlime. Each flavor will have glucose concentrations of 50, 75, 100 grams of D-glucose per 10 oz bottle.

The provided text is for a 510(k) summary for a "Glucose Drink," which is a glucose tolerance beverage used as an accessory to an In Vitro Diagnostic Glucose Tolerance Test.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of AI/ML performance evaluation.

Instead, it is a regulatory document demonstrating substantial equivalence of a glucose drink product to a predicate device. The "Performance Summary" states that the new device and the predicate device are similar in intended use, size, and technological characteristics, and that the product is manufactured using GMP to specifications from the World Health Organization and American Diabetes Association for such products.

Therefore, I cannot fulfill your request for the specific details outlined (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) as this information is not present in the provided text for this type of medical device submission.

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