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EasyDeX is a flavored non-carbonated beverage containing specific quantities of dextrose (D-glucose). The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle. This product is used in the administration of an in Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and other related disease conditions. This product is for oral consumption only.

EasyDeX is a water-based flavored beverage containing specific quantities of dextrose (d-glucose). The product is manufactured in two (2) flavors (Fruit Punch and Orange) and three (3) concentrations.

This 510(k) submission describes the EasyDeX device, a flavored glucose tolerance beverage. However, the provided document does not contain a study demonstrating the device's performance against specific acceptance criteria in the manner typically expected for a medical device with an AI component or complex diagnostic performance evaluation.

Instead, this submission is for a glucose tolerance drink, which is classified as an in vitro diagnostic (IVD) product. The regulatory review focuses on its composition, manufacturing, and equivalence to a predicate device, rather than on diagnostic accuracy metrics like sensitivity, specificity, or AI performance.

Therefore, many of the requested elements for describing acceptance criteria and a study design (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document describes a glucose tolerance beverage, not a diagnostic algorithm or device requiring a clinical test set with patient data. The "testing" referred to is for chemical composition and concentration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. The "ground truth" for this product is its chemical composition (glucose concentration), which is verified by laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of diagnostic data, which is not relevant to this product.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not a device with AI components or one that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this product is its chemical composition and concentration of dextrose, verified by in-house and independent laboratory testing. This ensures the product delivers the specified amount of glucose as intended.

8. The sample size for the training set

• Not Applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable.

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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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As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions.

The beverage is used as an accessory to an In Vitro Diagnostic Glucose Tolerance Test for the detection of glucose intolerance in the evaluation of diabetes mellitus and related disease conditions.

Glucose Tolerance Beverage is a water-based flavored beverage containing specific quantities of dextrose.

Glucose Tolerance Beverage is a water-based flavored beverage with specific amounts of dextrose.

The provided document is a 510(k) premarket notification for a medical device called "Glucose Tolerance Beverage". This device is a flavored drink containing dextrose, intended to be used as an accessory for an In Vitro Diagnostic Glucose Tolerance Test. The document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (Trutol, Glucose Tolerance Test Beverage).

Based on the information provided in the document, here's a breakdown of the requested criteria, with explanations where information is not present:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not report specific sample sizes for a test set or data provenance in the context of device performance, as it relies on demonstrating substantial equivalence rather than a clinical performance study with a test set of patient data. The "independent testing" refers to certification of the product's sugar composition and concentration, not a study involving patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided. The submission does not describe a study involving a test set with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no described test set or adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The device is a "Glucose Tolerance Beverage," not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. The device is a consumable component for a diagnostic test, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/not provided in the context of a clinical study. The "ground truth" for this device's performance relates to its chemical composition and manufacturing adherence to specifications (e.g., precise dextrose content), which are verified through independent certification rather than clinical ground truth measures like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

Summary of the "Study" (Performance Summary for Substantial Equivalence):

The "study" presented is not a traditional clinical trial or performance study comparing a new algorithm to human readers. Instead, it is an argument for substantial equivalence to a predicate device. The core of the performance summary states:

• "Glucose Tolerance Beverage and the predicate device are similar with respect to intended use, size and technological characteristics."
• "The product is manufactured using GMP to the specification ranges set by the World Health Organization and American Diabetes Association for such products."
• "All products are independently certified as to the sugar composition and concentration."

The conclusion is that the device "has the same intended use and characteristics as the predicate device" and that "independent testing demonstrates that the technological/packaging advances of the proposed device do not affect the characteristics of the contents and do not raise any new questions of safety or effectiveness."

Therefore, the "proof" the device meets acceptance criteria primarily relies on:

1. Comparison to a legally marketed predicate device: Demonstrating that the new device has the same intended use and similar technological characteristics.
2. Adherence to established manufacturing and content standards: Stating that the product is manufactured under Good Manufacturing Practices (GMP) and meets WHO and ADA specifications for glucose tolerance products, with independent certification of its sugar composition.

This approach is typical for 510(k) submissions where a device is deemed substantially equivalent to an existing device rather than requiring de novo clinical efficacy studies.

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