(550 days)
The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System did not include AI, therefore much of this information is not applicable.
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., specific percentages for accuracy within certain glucose ranges) or detailed performance statistics were provided in the document beyond a general statement of positive clinical study results.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "A clinical study was conducted with persons with diabetes to evaluate system accuracy and to assess ease of use." However, the sample size for this clinical study and the data provenance (country of origin, retrospective or prospective nature) are not specified.
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, as this device measures glucose and does not typically involve expert interpretation as a ground truth method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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, as this device measures glucose and does not involve human readers interpreting cases or AI assistance in that context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone blood glucose monitoring system. Its "performance" refers to the accuracy of its glucose measurements. The clinical study evaluated "system accuracy," which inherently means the performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For blood glucose monitoring systems, the ground truth for accuracy studies is typically established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer) known for its high accuracy in measuring blood glucose. The document does not explicitly state the specific ground truth method used, but it's universally implied for such devices.
8. The sample size for the training set
Not applicable, as this device does not utilize an AI algorithm 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.