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The On-Call® Plus Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in capillary whole blood from the fingertip, forearm, and/or palm by people with diabetes at home and by healthcare professionals as an aid in the monitoring the effectiveness of diabetes control programs.

The On-Call® Plus 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® Plus Blood Glucose control solution is for use with the On-Call® Plus Blood Glucose meter and strips as a quality control check to verify the accuracy of blood glucose test results.

The On-Call® Plus Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm, and/or 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 provided text describes the "On-Call® Plus Blood Glucose Monitoring System" and its substantial equivalence to a predicate device, the "One Touch Ultra Blood Glucose Monitoring System". The information primarily focuses on non-clinical and clinical performance to establish this equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly mentions compliance with 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" as the primary standard for accuracy requirements. While the document states the device meets these accuracy requirements, it does not provide a direct table detailing the specific accuracy acceptance criteria from ISO 15197:2003 (e.g. percentage of readings within ±15% or ±20% of reference measurements) nor does it report specific performance metrics against these criteria.

However, it does list several performance characteristics that were evaluated:

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

The text states: "Clinical studies were conducted with lay persons and trained laboratory technicians using the On-Call® Plus Blood Glucose Monitoring System."

• Sample Size: The exact sample size for the clinical test set is not provided in the given text.
• Data Provenance: The text does not explicitly state the country of origin. It can be inferred that the studies were likely conducted in the US, given the submission is to the FDA and references US regulatory documents. The studies are prospective clinical studies involving both lay persons and trained technicians.

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

• Ground Truth Establishment: The ground truth for the clinical studies was established by comparison to the YSI Model 2300 STAT PLUS (K913806). The YSI is a commonly accepted laboratory reference method for glucose measurement.
• Number of Experts/Qualifications: The text mentions "trained laboratory technicians" used the predicate device, but it does not specify the number or specific qualifications (e.g., years of experience) of these technicians. The YSI machine itself serves as the reference, not human interpreters in this context.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a blood glucose monitoring system. The accuracy is determined by direct comparison of the device's readings against a laboratory reference standard (YSI Model 2300 STAT PLUS), rather than human adjudication of interpretations.

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

• Was one done? No, a MRMC comparative effectiveness study was not done in the context of human readers improving with or without AI assistance. This device is a blood glucose meter, and the comparison is between the device's reading and a laboratory reference, not between human interpretations.
• Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component for interpretation by human readers. The clinical study did compare readings obtained by "lay persons" (users at home) to "trained technicians" using the same device, but this isn't a human-reader-with-AI vs. human-reader-without-AI scenario. The conclusion was that lay persons obtained "comparable" readings.

6. Standalone (Algorithm Only) Performance

• Was one done? Yes, the entire evaluation of the "On-Call® Plus Blood Glucose Monitoring System" is a standalone performance evaluation of the device as an algorithm/system. The device itself (meter and test strip) is the "algorithm" that measures glucose. Its performance is directly compared to the YSI reference. The clinical study specifically assesses the device's ability to provide accurate readings on its own when used by both lay persons and professionals.

7. Type of Ground Truth Used

The type of ground truth used for the clinical performance evaluation was a laboratory reference method: the YSI Model 2300 STAT PLUS (K913806).

8. Sample Size for the Training Set

The text does not specify the sample size for any training set. Given the time period (2009) and the nature of the device (blood glucose meter), it is highly likely that empirical calibration and validation methods were used rather than a large-scale "training set" in the modern machine learning sense. The "laboratory testing" mentioned (linearity, precision, etc.) would have involved various samples to characterize the device's inherent performance.

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

As discussed above, the concept of a separate "training set" with ground truth in the AI/ML sense is not explicitly presented or likely for this device. The development and calibration of such a device generally involve using reference methods (like YSI) to establish the accuracy of the electrochemical enzymatic assay at various glucose concentrations, across different hematocrit levels, temperatures, etc. This would have involved numerous laboratory samples where the true glucose concentration was known through the reference method. However, the specific details or distinction between "training" and "testing" samples in this context are not provided in the document.

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