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The On Call® Vivid Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). The On Call® Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. It is for in vitro diagnostic use only.

The On Call® Vivid Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus or for neonatal use.

The On Call® Vivid Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in fresh capillary blood from the fingertip, forearm, and palm.

The On Call® Vivid Blood Glucose Control Solution is for use with the On Call® Vivid Blood Glucose Meter and Test Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The On Call Vivid Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and forearm. The glucose measurement is achieved by using the amperometric detection method.

The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.

The On Call Vivid Blood Glucose Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, forearm, and palm.

Here's an analysis of the provided text regarding its acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to CLSI POCT12-A3 as the standard for accuracy. CLSI POCT12-A3 outlines specific accuracy criteria for point-of-care blood glucose meters. The document states that the testing demonstrated that the "On Call Vivid Blood Glucose Monitoring System meets the accuracy requirement of CLSI POCT12-A3," but it does not explicitly list the specific criteria from CLSI POCT12-A3 or the detailed reported device performance against those criteria in a table format within the provided text.

However, it does provide a summary of accuracy with reference to the laboratory reference method:

The document also further states the system achieved:

• Repeatability Study: SD of 2.1 mg/dL for 46 mg/dL, and CV of 2.7–3.0% for 100-300 mg/dL.
• Intermediate Precision Study: SD of 2.2 mg/dL for 46 mg/dL, and CV of 3.4–3.5% for 100-330 mg/dL.

2. Sample Size Used for the Test Set and Data Provenance:

The document states multiple studies were conducted:

• Clinical Study (Accuracy, Fingertip): 400 subjects. The provenance is not explicitly stated (e.g., country of origin) but it is a "clinical study," which typically implies prospective data collection from human subjects.
• Clinical Study (Accuracy, Alternative Sites - Forearm and Palm): 100 subjects for each alternative site (forearm and palm). The provenance is not explicitly stated.
• Interference Study: 18 interfering substances tested.
• Hematocrit Study: Demonstrated acceptable performance across a hematocrit range of 20-70%.
• Repeatability Study: 10 samples tested 10 times for a total of 100 measurements.
• Intermediate Precision Study: 10 samples tested on 10 different days/times for a total of 100 measurements.

All studies appear to be prospective as they describe testing performed with the device. The country of origin for the data is not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document states that the ground truth for the clinical studies was established using a "YSI 2300 STAT Plus Glucose Analyzer" as the laboratory reference method.

• No human experts were used to establish the primary ground truth. The YSI 2300 STAT Plus Glucose Analyzer is a widely accepted laboratory instrument for glucose measurement, acting as the verifiable reference.

4. Adjudication Method for the Test Set:

• No adjudication method is relevant as the ground truth was established by an objective laboratory reference instrument (YSI 2300 STAT Plus Glucose Analyzer), not by human expert consensus that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done or reported. This device is a blood glucose monitoring system, and its performance is typically evaluated against laboratory reference methods, not by comparing human reader performance with and without AI assistance. The concept of "human readers" in the context of interpreting results from this device is not directly applicable in the same way as, for example, image interpretation in radiology.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Yes, a standalone study was done. The described clinical studies and performance evaluations (accuracy, precision, interference, hematocrit) assess the device's performance independently against a reference standard. The "On Call Vivid Blood Glucose Monitoring System" itself produces the glucose reading, and its accuracy is measured directly. Human involvement is in operating the device and collecting the sample, but the measurement and calculation are done by the device's inherent algorithms.

7. Type of Ground Truth Used:

• The primary ground truth used for the accuracy studies was objective laboratory reference measurement by a YSI 2300 STAT Plus Glucose Analyzer.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for a "training set." For devices like blood glucose meters, the "training" usually refers to the development and calibration of the electrochemical system and algorithms, which is typically done internally by the manufacturer with extensive internal testing. The provided data focuses on the validation (test set) of the final device. It's unlikely that "training set" in the machine learning sense is relevant or would be disclosed in this type of submission.

9. How the Ground Truth for the Training Set Was Established:

• As mentioned above, the concept of a distinct "training set" with established ground truth for this type of device is not detailed in the document. The development and calibration of the device would involve rigorous internal testing against laboratory reference methods (similar to the YSI 2300 STAT Plus Glucose Analyzer) during the design and engineering phases to ensure the device outputs accurate glucose readings.

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