(146 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Acceptance Criteria (Implicit from 510(k) for this type of device): | The device is deemed "as safe, as effective, and performs as well or better than the predicate device." |
| - Composition and Concentration: The beverage must contain specific quantities of dextrose (d-glucose) as stated for its intended use (50, 75, and 100 grams per 10 oz. bottle). | "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." "The manufactured beverages contain three (3) different quantities of glucose; 50, 75, and 100 grams quantities per 10 oz. bottle." "All products will be tested and certified both in-house and by an independent laboratory for sugar composition and concentration." |
| - Manufacturing Quality: Manufactured under strict Current Good Manufacturing Practices (cGMP) to specifications set by WHO and ADA. | "The product is manufactured under strict Current Good Manufacturing Practices to the specifications set by the World Health Organization and the American Diabetes Association for this type of product." |
| - Safety and Effectiveness Equivalence: The device must be as safe and effective as the predicate device (Glucose Tolerance Beverage by Perk Scientific, Inc., K032753). | "This device has the same technological characteristics (composition and packaging) as the predicate device." "The device is as safe, as effective, and performs as well or better than the predicate device." |
| - Intended Use Equivalence: Used for administration of an in Vitro Diagnostic Glucose Tolerance Test for evaluation of diabetes mellitus and related conditions, for oral consumption. | The Intended Use statement for EasyDeX matches that of a standard glucose tolerance beverage. |
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.