(130 days)
The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
The FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System are designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of 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 whole blood and control solutions.
The provided text describes three blood glucose monitoring systems (FORA G72/TD-4264, FORA G70/TD-4273, and Ultra Trak Active) and asserts their substantial equivalence to a predicate device (CLEVER CHEK TD-4222 No-Code Blood Glucose Monitoring System). However, it does not provide explicit acceptance criteria or detailed study results proving the device meets specific performance metrics.
The text states:
- "FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
- "The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of systems meets the intended use."
This indicates that performance studies were conducted, but the specific acceptance criteria and the detailed results demonstrating how those criteria were met are not included in this summary.
Given the absence of the requested information in the provided document, I cannot populate the table and answer the study-specific questions fully.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Accuracy | Not specified in document | "demonstrated that the performance of systems meets the intended use." (Specific metrics like accuracy within a certain percentage or mg/dL are not provided). |
| Meter Reliability | Not specified in document | "demonstrated that the performance of systems meets the intended use." (Specific metrics are not provided). |
| Software Verification & Validation | Not specified in document | "demonstrated that the performance of systems meets the intended use." (Specific metrics are not provided). |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the document.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. For blood glucose monitoring systems, the "ground truth" for accuracy is typically established using a laboratory reference method (e.g., YSI analyzer) rather than expert consensus on interpretations. The document does not detail how the ground truth was established for the "system accuracy" study.
4. Adjudication method for the test set
- Not applicable/Not specified. Given the nature of a blood glucose measurement device, adjudication by experts is not typically part of the accuracy assessment for the primary output (glucose concentration).
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
- No MRMC study was done. This is a standalone diagnostic device for measuring glucose, not an AI-assisted diagnostic imaging or interpretation system that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "System Accuracy" study would assess the standalone performance of the device (meter + strip) against a reference standard. The document states this study was done, but gives no details.
7. The type of ground truth used
- Not specified in the document. For blood glucose meters, the ground truth is typically a laboratory reference method (e.g., YSI glucose analyzer) rather than expert consensus or pathology.
8. The sample size for the training set
- Not applicable/Not specified. This device is described as operating on an electrochemical principle with a dry reagent biosensor. While there might be internal calibrations, the concept of a "training set" as understood in machine learning (which explicitly uses algorithms trained on data) is not directly applicable or described for this type of device in the provided summary.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See point 8)
§ 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.