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The ACCU-CHEK Aviva Connect 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. The ACCU-CHEK Aviva Connect Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Aviva Connect 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 Connect Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

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

For in vitro diagnostic use

The ACCU-CHEK Aviva Connect blood glucose monitoring system is a blood glucose monitoring system that makes use of the ACCU-CHEK Aviva Connect meter, the ACCU-CHEK Aviva Plus test strips (K101299), and the ACCU-CHEK Aviva control solutions (K101299). The ACCU-CHEK Aviva Connect meter is a modification of the ACCU-CHEK Aviva meter (K133862) with an improved design and the addition of a USB port and the BLE communication capability.

The provided text describes the ACCU-CHEK Aviva Connect Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with all the requested information for acceptance criteria and device performance.

Based on the available information, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions "Precision: For response targets

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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 modified ACCU-CHEK Aviva meter used in conjunction with the ACCU-CHEK® Aviva Plus test strips. The new ACCU-CHEK Aviva meter no longer uses a code key.

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 ACCU-CHEK Aviva Plus Blood Glucose Monitoring System, focusing on acceptance criteria and study details.

Based only on the provided text, the specific details regarding the acceptance criteria and a detailed study proving the device meets them are very limited. The document is primarily a 510(k) summary for a modified device, emphasizing its substantial equivalence to a predicate device.

Here's what can be extracted and what is explicitly not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it makes a general statement about meeting performance requirements and being substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document only states "Performance testing on the ACCU-CHEK Aviva System demonstrated..."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the given text. For blood glucose monitoring systems, ground truth is typically established using a high-precision laboratory reference method, not necessarily by human experts in the same way it would be for imaging diagnostics. The text does not elaborate on the method used to establish reference glucose values.

4. Adjudication method

This information is not provided in the given text.

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

• MRMC Study: Not applicable/not mentioned. This device is a blood glucose monitoring system, which typically does not involve human "readers" interpreting results in the same way an imaging AI system would. Its primary function is to provide a quantitative measurement.
• AI Improvement Effect Size: Not applicable. There is no mention of AI integration in this blood glucose monitoring system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a standalone system in the sense that the meter provides the glucose reading without requiring human interpretation or intervention beyond performing the test procedure. However, the document does not distinguish between "standalone algorithm performance" and "system performance" as it might for an AI-driven diagnostic. The "performance testing" referred to would inherently be of the "algorithm only" (i.e., the device's measurement capability) without a human interpreting the result to determine the glucose level.

7. The type of ground truth used

The type of ground truth is not explicitly stated beyond the implication that it's a quantitative measurement of glucose. For blood glucose meters, the ground truth is typically established by comparative measurements against a laboratory reference method (e.g., YSI analyzer) known for its high accuracy. The text only mentions "quantitative measurement of glucose (sugar)."

8. The sample size for the training set

This information is not provided in the given text. Blood glucose meters are not typically "trained" in the same way a machine learning algorithm would be. Their performance is based on the chemical and electrical design of the test strip and meter. If any statistical models or calibrations were involved, the training set details are omitted.

9. How the ground truth for the training set was established

This information is not provided in the given text. (See point 8 regarding "training set.")

Summary of Limitations due to Document Scope:

The provided document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device for a modified blood glucose monitoring system (specifically, a meter that no longer uses a code key). It states that performance testing was done and that the device "meets the performance requirements for its intended use" and is "substantially equivalent to the predicate device." However, it does not provide detailed technical specifications, exact acceptance criteria, or granular study results (like sample sizes for performance studies, specific ground truth methods, or any statistical analysis) that would be found in a full submission or a detailed study report. These details are often proprietary or contained in other sections of a 510(k) submission not included here.

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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 Nano SmartView 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 or palm. The ACCU-CHEK Nano SmartView Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The ACCU-CHEK Nano SmartView 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 Nano Smartview 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* SmartView Test Strips are for use with the ACCU-CHEK Nano Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.

The ACCU-CHEK® Nano meter was developed to utilize the ACCU-CHEK® Aviva Plus test system's technology and performance characteristics. The ACCU-CHEK® Nano meter designers took the measurement components of the ACCU-CHEK® Aviva Plus system, slightly changed the firmware and hardware supporting the new user interface and housing and embedded/programmed the strip lot code information within the meter so a physical code key or code key port are no longer used.

The ACCU-CHEK ® SmartView test strip is a No Code Freedom 2 Chemistry test strip which shares the same scientific technology as the predicate device, the ACCU-CHEK® Aviva Plus test strips. The instrument's measurement method is not modified as a part of this test strip modification project.

When an ACCU-CHEK® SmartView test strip is inserted into the ACCU-CHEK® Nano meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes – both are used to assure an adequate sample has been applied.

The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.

After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.

The single-patient use ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System will consist of:

Meter: ACCU-CHEK® Nano Meter Test Strip: ACCU-CHEK® SmartView Test Strip Controls: ACCU-CHEK® SmartView Control Solutions

The provided text describes the ACCU-CHEK Nano SmartView Blood Glucose Monitoring System and its substantial equivalence to a predicate device. However, it does not explicitly detail the acceptance criteria for performance, nor does it present the results of a specific study in the format requested. The document primarily focuses on the device's description, intended use, and a statement of substantial equivalence based on "performance testing."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, information on sample sizes for a test set, ground truth establishment methods, expert qualifications, adjudication methods, or details about MRMC or standalone studies with specific effect sizes from the provided text.

The text does state: "Performance testing on the ACCU-CHEK® Nano SmartView Blood Glucose Monitoring System demonstrated that the device meets the performance requirements for its intended use. The data demonstrates that the test strip is substantially equivalent to the predicate device." This indicates that such testing was conducted and met predefined criteria, but the specific details are not included in this summary.

Based on the provided input, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:

   • Not explicitly provided in the text. The document states that performance testing demonstrated that the device meets the performance requirements for its intended use and that the test strip is substantially equivalent to the predicate device. Specific numerical acceptance criteria and reported performance values are not given.

2. Sample sized used for the test set and the data provenance:

   • Not explicitly provided in the text. The document mentions "Performance testing," but does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable/provided in the text. For a blood glucose monitoring system, the "ground truth" is typically established by comparative measurements against a well-established laboratory reference method, not through expert consensus in the way it would be for image interpretation by clinicians. The text does not detail the specific ground truth method used for performance testing or the involvement of human "experts" in establishing it beyond the use of a reference method.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/provided in the text. Adjudication methods are typically used when multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth or resolve discrepancies. This is not directly relevant to the performance testing of a blood glucose monitoring system, which typically involves comparison to a reference method.

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:

   • No, an MRMC study was not done (and is not applicable). This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers. Its purpose is direct measurement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, effectively. The performance testing described (though details are absent) would inherently be a standalone evaluation of the device's accuracy in measuring glucose levels against a reference. The device itself is an "algorithm only" type of system in that it measures and reports a value without human interpretation in the loop of the measurement process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Implied to be a laboratory reference method. For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings against results from a highly accurate laboratory analyzer (e.g., YSI analyzer) measuring the same blood samples. This is not explicitly stated but is the standard practice for such devices.

8. The sample size for the training set:

   • Not explicitly provided in the text. This document describes a 510(k) submission, which focuses on performance data for substantial equivalence, not the development or training of an algorithm in the machine learning sense. While the device utilizes embedded firmware and hardware, the concept of a "training set" in the context of AI or machine learning is not discussed for this type of device.

9. How the ground truth for the training set was established:

   • Not applicable/provided in the text. As mentioned above, a "training set" in the context of algorithm development for machine learning is not discussed for this device.

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