(74 days)
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
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | The device's intended use is "As an accessory to an In Vitro Diagnostic Glucose Tolerance Test in the evaluation of diabetes mellitus and related disease conditions." | The device is substantially equivalent to the predicate device in terms of intended use. |
| Material/Composition | Flavored beverage containing specific quantities of dextrose. | The document states "All contents other than water and dextrose are used strictly for flavoring and preservative characteristics and do not alter the overall dextrose content." |
| Manufacturing Standards | Manufactured using GMP to the specification ranges set by the World Health Organization and American Diabetes Association for such products. | Independent certification confirms sugar composition and concentration. |
| Technological Characteristics | Similar to the predicate device. | The submission argues that "technological/packaging advances of the proposed device do not affect the characteristics of the contents". |
| Performance (Dextrose Content) | All products are independently certified as to the sugar composition and concentration. | This indicates the device meets established specifications for its active ingredient. |
| Safety and Effectiveness | The device is safe, and packaging performance characteristics are substantially equivalent to or better than the predicate device. | This is the overall conclusion of the substantial equivalence claim. The premise is that by being substantially equivalent to a device marketed prior to May 28, 1976, its safety and effectiveness are established. |
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:
- Comparison to a legally marketed predicate device: Demonstrating that the new device has the same intended use and similar technological characteristics.
- 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.
§ 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.