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The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of Insulin-requiring diabetes. The ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert System is Intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.

The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of giucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood giucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Altemative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The ACCU-CHEK Aviva Expert System is intended for prescription home use only.

The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucase, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a preplanned treatment program from a healthcare professional. Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus Advisor settings.

The ACCU-CHEK Aviva Expert System consists of the following:

• ACCU-CHEK Aviva Expert meter .
• ACCU-CHEK Bolus Advisor (a component of the Aviva Expert meter) .
• . ACCU-CHEK Aviva Plus test strips (K101299)
• ACCU-CHEK Aviva control solutions (K043474) .

The ACCU-CHEK Aviva Expert system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Plus test strips (cleared under K101299) and the ACCU-CHEK Aviva control solutions (cleared under K043474). The industrial design of the ACCU-CHEK Aviva Expert meter is nearly identical to that of the ACCU-CHEK Aviva Combo meter (cleared under kl 11353); the only difference between the two devices is that the ACCU-CHEK Aviva Expert meter does not have Bluetooth wireless capability and therefore cannot be connected to an insulin pump, whereas the ACCU-CHEK Aviva Combo meter does have Bluetooth capability and can be connected to an insulin pump.

The ACCU-CHEK Aviva Expert system provides the user with the ability to measure capillary blood glucose levels when a sample of capillary blood is applied to the test strip. The meter also provides an optional insulin bolus calculator (the ACCU-CHEK Bolus Advisor) designed for use by individuals with diabetes who require insulin. This feature is optional in that a user can simply obtain a blood glucose value through capillary blood testing and does not need to use the insulin bolus calculator portion of the system if it is not desired. The insulin bolus calculator algorithm is identical to the bolus calculator algorithm that was cleared during the Aviva Combo 510(k) submission (K111353). For the ACCU-CHEK Aviva Expert system, this bolus calculator is meant to be used by patients with diabetes on multiple daily insulin injection (MDI) therapy. In order to calculate the appropriate bolus of insulin, the ACCU-CHEK Bolus Advisor takes the measured bG, the target bG, the carbohydrate intake, the insulin-to-carbohydrate ratio, the insulin sensitivity, health events (such as exercise), the time of day, and the active insulin into account. Before using the ACCU-CHEK Aviva Expert system, a physician or healthcare professional must provide the patient-specific target blood glucose, insulinto-carbohydrate ration, and insulin sensitivity parameters.

Here's a detailed breakdown of the acceptance criteria and study information for the ACCU-CHEK Aviva Expert System, based on the provided 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 (or similar standards) for accuracy. The provided document details the accuracy of the device against a reference method. It also outlines precision performance.

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

• Accuracy Test Set (Method Comparison):
  • For glucose concentrations less than 75 mg/dL: 48 samples
  • For glucose concentrations greater than or equal to 75 mg/dL: 252 samples
• Precision Test Set (Repeatability - Within Lot): 100 samples for each of 5 glucose levels.
• Precision Test Set (Reproducibility - Day-to-Day): 100 samples for each of 3 control solution levels.
• Data Provenance: Not explicitly stated in the provided text, but it’s typically part of a controlled clinical or laboratory study. It can be assumed to be from a prospective study, likely conducted internally or by a contracted lab, designed to evaluate the device's performance. The country of origin is not specified.

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

This information is not provided in the given 510(k) summary. For glucose monitoring systems, ground truth is typically established by a laboratory reference method (e.g., YSI analyzer) operated by trained laboratory professionals, rather than by medical experts establishing a diagnosis. The summary mentions "laboratory reference" implicitly by comparing results to specified mg/dL or percentage deviations.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable in the context of blood glucose meter accuracy studies. The ground truth (reference method glucose value) serves as the definitive comparator, and there is no "adjudication" necessary between multiple interpretations of this ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic systems where human readers interpret medical images or data, and an AI might assist in that interpretation. The ACCU-CHEK Aviva Expert System is a blood glucose meter with an optional bolus calculator, not an imaging or interpretive AI system that a human "reads." While it has an "Expert System" and "Bolus Advisor" component, this is an algorithm that provides a calculation rather than an AI assisting human interpretation of complex medical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (accuracy and precision) represents the standalone performance of the ACCU-CHEK Aviva Expert System as a blood glucose meter. The bolus advisor component is an algorithm that provides a calculation based on input, and its performance would be assessed algorithmically (e.g., accuracy of dosage calculation based on given parameters), which would inherently be a "standalone" algorithmic evaluation. The provided data focuses on the glucose measurement accuracy, which is the primary standalone function.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study is a laboratory reference method for blood glucose measurement. This is implied by the phrasing "Results for glucose concentrations less/greater than or equal to 75 mg/dL" and the comparison to numeric deviations (± mg/dL or ± %). For such devices, a highly accurate laboratory analyzer (e.g., YSI Glucose Analyzer) is the standard for establishing ground truth.

8. The Sample Size for the Training Set

The provided 510(k) summary does not specify the sample size for any training set. Given that this device is presenting itself as substantially equivalent based on identical core technology (test strip, bG measurement algorithm, bolus calculator algorithm) to a previously cleared predicate device, extensive new training data for foundational algorithms like glucose measurement might not have been required for this specific submission if the underlying algorithms were already established and validated in the predicate. If any specific machine learning or adaptable components were newly introduced, their training data would typically be described. However, the bolus calculator algorithm is stated to be "identical" to the predicate.

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

Since no training set details are provided, information on how its ground truth was established is not available in this document. If new training data were used for any component, the ground truth would likely also be established via a laboratory reference method for blood glucose values and clinical scenarios for bolus calculations.

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