(84 days)
The CareSens N Mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Mini Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the CareSens N Mini Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N Mini Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the following: the CareSens N Mini Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately}, Lancing Device, Lancets, User's Manual, Quick Reference Guide and Logbook.
The provided document describes the "CareSens N Mini Blood Glucose Monitoring System" and details its performance assessment. However, it does not provide a table of acceptance criteria and reported device performance. It only states that validation testing, including a meter function test and system accuracy test, was conducted to confirm that modifications did not introduce any adverse effects, and that the device met performance, safety, and effectiveness for its intended use.
Therefore, many of the requested details cannot be extracted from this document based on the provided input.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided based on the input. The document states that validation testing was conducted and the device "met the performance, safety, and effectiveness," but it does not specify the acceptance criteria (e.g., accuracy % within certain ranges, precision limits) nor does it provide detailed reported performance values.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided based on the input for system accuracy testing. The document mentions a "human factor study" was conducted to evaluate usability, and "260 each of pre-cleaning and disinfection cycles" were performed for disinfection studies. However, for the core "system accuracy test" that would assess glucose measurement performance, the sample size, data provenance, or study design (retrospective/prospective) are not detailed.
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/Cannot be provided based on the input. For a blood glucose monitoring system, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer), not by human experts interpreting results. The document does not mention the method used to establish reference glucose values.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided based on the input. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology AI studies) where multiple experts review cases and resolve discrepancies. This is not relevant for a blood glucose meter's accuracy testing.
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. MRMC studies are used for evaluating AI systems that assist human readers in tasks like image interpretation. This device is a standalone blood glucose meter, not an AI assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone algorithm/system. Its performance is measured directly without a human-in-the-loop interaction in the sense of an AI assisting a human clinician's judgment. The "system accuracy test" described would be a standalone evaluation of the device's measurement capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but implicitly a laboratory reference method. For blood glucose meters, the ground truth is established by measuring the same blood samples with a highly accurate laboratory reference instrument (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the reference method used.
8. The sample size for the training set
- Not applicable/Cannot be provided based on the input. This device is a blood glucose meter using an amperometric method with glucose oxidase; it is not described as an AI/machine learning device that would typically have a "training set" in the contemporary sense. Its "algorithm" is based on established electrochemical principles.
9. How the ground truth for the training set was established
- Not applicable. As above, the concept of a "training set" with ground truth in this context is 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.