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The On Call® Vivid Pro Blood Glucose Monitoring System is an electrochemical enzymatic assay. It is used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. The On Call® Vivid Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, autodisabling lancing devices.

The On Call® Vivid Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates.

The On Call® Vivid Pro Blood Glucose Test Strips are used with the On Call Vivid Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the finger.

The On Call® Vivid Pro Blood Glucose Control Solutions are for use with the On Call® Vivid Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.

The On Call" Vivid Pro Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. 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. This 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 quality control of the On Call Vivid Pro Blood Glucose Monitoring System is performed by testing the test strip on meter with glucose control solution to confirm that the test strip and meter are working together properly. The glucose control solution contains a known concentration of glucose with preservatives in an aqueous based mixture. The control solution test result should fall within the predetermined control solution range for the given strip lot to confirm the accuracy of the On Call Vivid Pro Blood Glucose Monitoring System.

Here's an analysis of the On Call Vivid Pro Blood Glucose Monitoring System's acceptance criteria and the study proving it meets them, based on the provided text:

Acceptance Criteria and Device Performance for On Call Vivid Pro Blood Glucose Monitoring System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the device's accuracy was evaluated against the requirements of EN ISO 15197:2003 "In vitro diagnostic test systems - Requirements for in vitro whole blood glucose monitoring systems intended for use by patients for self testing in management of diabetes mellitus."

The key performance criterion mentioned in the conclusion is "accuracy requirements per EN ISO 15197". While the document doesn't explicitly list the detailed accuracy thresholds from this standard, it states that the system meets these requirements.

Table: Acceptance Criteria (Referenced Standard) and Device Performance (Study Conclusion)

Note: The specific numerical accuracy criteria (e.g., error grid analysis outcomes, percentage of results within a certain margin of a reference method) for EN ISO 15197:2003 are not provided in this summary but are the underlying benchmark mentioned.

Other performance characteristics evaluated as part of non-clinical tests (though specific acceptance values aren't typically stated as "acceptance criteria" but rather as "specifications" for these types of devices in 510k summaries):

• Repeatability precision
• Intermediate precision
• Linearity
• Interfering agents
• Hematocrit effect
• Temperature effect evaluation (blood & control solution)
• Low battery effect
• Altitude effect
• Sample volume
• Humidity effect
• Simulated shipping study (test strip & control solution)
• Control value assignment
• Meter testing
• Software validation testing
• Electromagnetic compatibility and electrical safety testing

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

• Sample Size for Clinical Tests: The document states "Clinical studies were conducted with lay persons and trained laboratory technicians". It does not specify the exact number of participants (sample size) for these clinical studies.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, as it's a 510(k) submission to the US FDA, and the company is based in San Diego, California, it's highly probable the clinical studies were conducted in the United States. The study is prospective, as it explicitly mentions "Clinical studies were conducted" to evaluate the system's accuracy.

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

• Reference Method: The ground truth was established by the YSI Model 2300 STAT PLUS (K913806). This is a laboratory-grade reference instrument for glucose measurement, widely considered a "gold standard" in blood glucose monitoring studies.
• Number of "Experts" for Ground Truth: While the YSI 2300 STAT PLUS is an automated instrument, its operation and validation would typically be performed by trained laboratory technicians. The document implicitly refers to these "trained laboratory technicians" as performing the reference measurements, stating "compared to the YSI Model 2300 STAT PLUS... per the ACON Clinical Study Protocol for the Blood Glucose Monitoring System." The number of these technicians isn't specified, but their qualification is "trained laboratory technicians."

4. Adjudication Method for the Test Set

• No explicit adjudication method is mentioned. The comparison is directly between the result from the On Call Vivid Pro system and the established reference device (YSI Model 2300 STAT PLUS).

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

• No, a typical MRMC comparative effectiveness study, as understood in the context of radiology or image interpretation where human readers interpret cases with and without AI assistance, was not conducted.
• Instead, this study compared the device's performance against a reference standard (YSI Model 2300 STAT PLUS) and evaluated the comparable results between "lay persons" (users of the device) and "trained laboratory technicians" (who often run the reference method). The focus was on the device's accuracy and ease of use for its intended users, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the accuracy study comparing the On Call Vivid Pro Blood Glucose Monitoring System to the YSI Model 2300 STAT PLUS effectively represents a standalone performance evaluation of the device.
• The device, an electrochemical enzymatic assay, inherently provides an algorithmic output (the glucose reading) based on the electrochemical reaction on the test strip and the meter's calculation. Its performance is assessed independently of further human interpretation or intervention to correct its reading beyond its basic operation. The study evaluated "the system accuracy of the On Call Vivid Pro Blood Glucose Monitoring System."

7. Type of Ground Truth Used

• The ground truth used was a reference laboratory instrument's measurement (YSI Model 2300 STAT PLUS). This is a highly accurate and established method for quantifiable analyte measurement.

8. Sample Size for the Training Set

• The document does not specify a separate "training set" sample size or discuss how a training set was used. For a blood glucose monitoring system like this, the "development" or "training" of the system would typically involve extensive engineering, chemical formulation, and calibration efforts during the design phase, rather than a distinct "training set" of patient data as might be seen for AI/ML algorithms that learn from data. The clinical studies described are for validation (test set), not training.

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

• Given that a specific "training set" for an AI/ML algorithm isn't described for this device, a method for establishing its ground truth is not applicable in this context. The development of the system's internal algorithms (e.g., for converting electrical current to glucose concentration) would be based on fundamental electrochemical principles, extensive laboratory testing with known glucose concentrations, and calibration against reference methods during the device's engineering and manufacturing process.

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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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