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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.

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The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).

The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

The ACCU-CHEK Combo System is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK 360° Insulin Pump Configuration software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Combo blood glucose monitoring system.

The ACCU-CHEK Aviva Plus test strips are for use with the ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.

For in vitro diagnostic use

The ACCU-CHEK Aviva Combo system is intended for single patient use and should not be shared.

The modified Black Code Key used in conjunction with the ACCU-CHEK® Aviva meter and the ACCU-CHEK® Aviva Combo meter.

The Black Code Key contains a universal code and can be used on all released ACCU-CHEK Aviva Plus test strip lots.

The single-patient use ACCU-CHEK Aviva Blood Glucose Monitoring System will consist of:
Meter: ACCU-CHEK Aviva Meter
Test Strip: ACCU-CHEK Aviva Plus Test Strip
Controls: ACCU-CHEK Aviva Control Solutions

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACCU-CHEK® Aviva Plus Blood Glucose Monitoring System and ACCU-CHEK® Aviva Combo System.

It's important to note that the provided 510(k) summary is quite brief on the specific details of the performance study. While it states that "Performance testing... demonstrated that the device meets the performance requirements for its intended use," it does not explicitly list the acceptance criteria or show a detailed comparison table with reported device performance metrics. It also lacks detailed information about the study design that would address many of your specific questions.

Based on the provided text, here's what can be extracted and what remains unknown:

Description of the Acceptance Criteria and Study

The document, a 510(k) summary for the ACCU-CHEK® Aviva Plus and ACCU-CHEK® Aviva Combo Systems, states that performance testing was conducted to demonstrate substantial equivalence to predicate devices (K101299 and K111353, respectively). The key modification described is the use of a "Black Code Key" with a universal code, implying that the core testing mechanism (test strip and meter) remains largely the same as the predicate devices, but the coding simplification was evaluated.

The summary asserts that the device meets the performance requirements for its intended use and that the test strip is substantially equivalent to the predicate device. However, the specific quantitative acceptance criteria (e.g., accuracy percentages within certain glucose ranges, precision limits) and the detailed results of the study are not included in this document. Such details are typically found in the full 510(k) submission, which is more extensive than this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not explicitly state the specific quantitative acceptance criteria or report detailed device performance metrics in a table format. It only makes a general statement that the device meets performance requirements. For typical blood glucose meters, acceptance criteria would generally refer to standards like ISO 15197 (e.g., N% of results within ±15 mg/dL or ±15% of the reference value). Without this information in the provided text, a table cannot be constructed.

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

The provided text does not specify the sample size used for the test set.

• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though performance evaluation studies for new medical devices are almost always prospective.

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

The provided text does not specify the number or qualifications of experts used to establish ground truth. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer), not necessarily human experts in adjudication.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method. This is typically not relevant for blood glucose meter performance studies, where each sample is measured against a definitive laboratory reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are primarily relevant for imaging diagnostics or other subjective interpretation tasks where multiple human readers interpret cases. For blood glucose meters, the performance is measured objectively against a reference method.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study performed for the ACCU-CHEK® Aviva Plus and ACCU-CHEK® Aviva Combo Systems is inherently a standalone (algorithm only) performance evaluation. Blood glucose meters do not involve "human-in-the-loop" interpretation in the same way imaging AI does. The device (meter + test strip) directly provides a quantitative glucose measurement. The study assesses the accuracy of this quantitative result compared to a reference method, independent of human interpretation.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used. However, for blood glucose monitoring systems, the standard ground truth for accuracy studies is typically a laboratory reference method (e.g., a YSI STAT PLUS glucose and L-lactate analyzer) that provides highly accurate glucose measurements from venous blood samples. This is considered the gold standard for comparison. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The provided text does not specify any training set size. Blood glucose monitoring systems like ACCU-CHEK Aviva are typically developed and calibrated based on extensive laboratory testing and chemical engineering principles, rather than machine learning models that require a "training set" in the common sense of AI/ML. If there were any machine learning components, no details are provided here.

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

As no "training set" in the context of machine learning is indicated, the document does not describe how ground truth for such a set was established. Device calibration and development would be based on established chemical analysis methods and numerous internal studies.

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