(140 days)
The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. The system also provides voice broadcast function when the meter is used to test.
The provided document (K060467) pertains to the 510(k) summary for the Prodigy Blood Glucose System. After careful review, the document does not contain the detailed acceptance criteria or the specific study results that would allow for a complete description of the device's performance against such criteria.
The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (TaiDoc Technology Corporation, K042005) rather than providing a detailed performance study against pre-defined acceptance criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information regarding sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
Here's what can be extracted and inferred from the text regarding safety and effectiveness:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states: "The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate." However, it does not detail what specific acceptance criteria were used or the quantitative performance results against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.
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):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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/provided. The Prodigy Blood Glucose System is an in-vitro diagnostic device for measuring glucose, not an AI-assisted diagnostic tool requiring multi-reader studies with human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The Prodigy Blood Glucose System is an electrochemical method-based meter. Its performance is inherent to the device itself (strip and meter interaction). The concept of "standalone algorithm only" is not directly applicable in the same way it would be for image analysis AI. The "standalone" performance would be its accuracy in measuring glucose values, which is generally evaluated in clinical trials using reference methods. However, the details of such a trial are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For blood glucose measurement systems, the "ground truth" is typically established by comparing the device's readings against a laboratory reference method (e.g., a YSI analyzer) with high accuracy and precision. While the document mentions "clinical and non-clinical testing data," it does not explicitly state the type of ground truth method used.
8. The sample size for the training set:
This information is not provided in the document. (Note: For a traditional electrochemical blood glucose meter, the concept of a "training set" as understood in machine learning is not directly applicable. Calibration data and internal validation data would be collected during development and manufacturing, but specific "training set" size for an algorithm is not relevant here).
9. How the ground truth for the training set was established:
As above, this information is not provided and the concept of "training set ground truth" is not directly applicable in the context of this device type.
Summary of available device performance information (from the "Similarities" table):
| Item | New Device: Prodigy | Predicate K042005 |
|---|---|---|
| Enzyme | Glucose oxidase | Glucose oxidase |
| Test range | 20-600 mg/dL | 20-600 mg/dL |
| Sample volume | 0.7 uL | 1.8-2.5 uL |
| Test time | 7 sec. | 10 sec. |
This table highlights technical specifications and equivalence, but not detailed accuracy performance against clinical acceptance criteria.
§ 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.