(190 days)
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. 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, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The GLUCOCARD® Vital™ 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 provided text describes the GLUCOCARD® Vital™ Blood Glucose Monitoring System, a device intended for the quantitative measurement of glucose in fresh capillary whole blood.
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance:
The document only broadly states that "A full array of in-house and clinical testing was done consistent with relevant FDA guidance's for blood glucose monitoring systems." While it mentions evaluations for interferences, dynamic range and linearity, hematocrit effects, altitude effects, control solution functionality, and analytical precision, it does not explicitly list specific numerical acceptance criteria or the reported performance for these criteria. The conclusion states that "clinical testing results support the Indications for Use and the claim of substantial equivalence to the predicate," but no hard numbers are given.
Therefore, a table of acceptance criteria and reported device performance cannot be created from the provided text.
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 "clinical testing included evaluation of accuracy for finger stick and palm test sites for GLUCOCARD® Vital™." However, it does not specify the sample size used for this clinical testing or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For blood glucose monitoring systems, ground truth is typically established using a reference laboratory method, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method. This is generally not applicable to blood glucose monitoring systems where comparison is made against a laboratory reference method.
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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone blood glucose monitoring system. The accuracy evaluation performed in clinical testing is inherently a "standalone" performance assessment of the device against a reference method. The document does not explicitly state "standalone performance study," but the nature of the device and testing implies it.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a blood glucose monitoring system, the ground truth is typically established by comparing the device's readings to those obtained from a laboratory reference method (e.g., a glucose analyzer in a clinical lab). While the document states "clinical testing included evaluation of accuracy," it does not explicitly name the type of ground truth used, though it can be inferred to be a laboratory reference method common for such devices.
8. The sample size for the training set:
This device is a traditional medical device (a glucose meter) and does not inherently involve machine learning algorithms that would require a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable to this device.
9. How the ground truth for the training set was established:
As the concept of a training set is not applicable, this question is not relevant.
§ 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.