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510(k) Data Aggregation
(151 days)
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.
| Performance Metric | Acceptance Criteria (Implied by Predicate/General Standards) | Reported Device Performance |
|---|---|---|
| Accuracy (Method Comparison) | ||
| Glucose 95% of results within ±15 mg/dL of laboratory reference (a common standard for this range) | 41/48 (85.4%) within ±5 mg/dL | |
| 48/48 (100%) within ±10 mg/dL | ||
| 48/48 (100%) within ±15 mg/dL | ||
| Glucose ≥ 75 mg/dL | >95% of results within ±15% of laboratory reference (a common standard for this range) | 147/252 (58.3%) within ±5% |
| 222/252 (88.1%) within ±10% | ||
| 246/252 (97.6%) within ±15% | ||
| 250/252 (99.2%) within ±20% | ||
| Precision (Repeatability - Within Lot) | For targets |
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(499 days)
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 test strip is a blood glucose testing product used in conjunction with the ACCU-CHEK® Aviva meter.
Through the use of molecular-cloning techniques, Roche has modified the GDH enzyme to improve specificity for glucose; the modified reaction is referred to hereafter as Mut. Q-GDH.
The newly advanced test strip measures blood glucose rapidly and reliably via an electrochemical detection technique. The new version of the test strip employs a disposable dry reagent based on the Mut. Q-GDH method for glucose determination.
When a drop of blood is applied to the test strip, modified glucose dehydrogenase catalyzes the oxidation of glucose. During the reaction, electrons are transferred via the coenzyme PQQ and an electrochemical mediator to the surface of the electrode. Current generated by the reaction is proportional to the concentration of glucose present in the blood sample.
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
The provided text describes the ACCU-CHEK Aviva Plus Blood Glucose Monitoring System and its substantial equivalence determination. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study report with quantitative performance data (beyond the general statement of meeting performance requirements), sample sizes for test/training sets, expert qualifications, or details about ground truth establishment.
Based only on the provided text, here's what can be extracted and what remains unknown regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use." However, it does not explicitly list the specific acceptance criteria (e.g., accuracy percentages, bias limits) or numerical reported device performance against those criteria.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (General statement) |
|---|---|
| Specific accuracy metrics and thresholds for blood glucose measurement are not provided. | "The device meets the performance requirements for its intended use." |
| Specific precision metrics are not provided. | "The data demonstrates that the test strip is 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 or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not specified in the provided text.
4. Adjudication Method for the Test Set
Not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was a MRMC study done? Not mentioned. The device is a blood glucose monitoring system, which typically involves a single user and an automated result, not multiple human readers interpreting results. Therefore, an MRMC study is highly unlikely for this type of device.
- Effect size of human readers with/without AI assistance: Not applicable, as this is not an AI-assisted diagnostic imaging or interpretation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone system for measuring blood glucose. The "algorithm" here refers to the electrochemical detection technique and modified enzyme chemistry. The performance testing would inherently be standalone, as it measures the device's output given a sample. The document states, "Performance testing on the ACCU-CHEK Aviva System demonstrated that the device meets the performance requirements for its intended use." This implies a standalone evaluation.
7. The Type of Ground Truth Used
While not explicitly stated, for a blood glucose monitoring system, the ground truth for testing would typically be established by a laboratory reference method (e.g., a YSI analyzer or similar highly accurate laboratory-grade glucose measurement instrument).
8. The Sample Size for the Training Set
Not specified in the provided text. (It's worth noting that for this type of electrochemical device, "training set" might not be directly analogous to machine learning model training. Instead, it refers to the data used during the development and optimization of the chemical and hardware components, which isn't detailed here).
9. How the Ground Truth for the Training Set Was Established
Not specified in the provided text. (Similar to point 8, this would likely involve comparison to laboratory reference methods during development).
Summary of Missing Information:
The provided text serves as a 510(k) summary, which outlines the device's purpose and its substantial equivalence to a predicate device. It primarily focuses on the regulatory aspects and a high-level description of the technology. It does not include the granular details of the performance study design, specific acceptance criteria values, quantitative performance results, sample sizes for testing/training, or details about ground truth establishment that would typically be found in a full study report or detailed submission. The statement "Performance testing... demonstrated that the device meets the performance requirements" is a conclusion, not a detailed presentation of the data itself.
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(156 days)
The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
The ACCU-CHEK Aviva Test Strips are stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported.
The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives a blood glucose results.
The provided text is a 510(k) Summary for ACCU-CHEK® Aviva Test Strips. This document primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing. It does not contain a detailed study report with acceptance criteria and specific performance data in the format requested.
The document discusses the intended use, device description, and similarities/differences to the predicate device, but it lacks the specific study details (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established) that would typically be found in a comprehensive performance study report.
Therefore, I cannot fully complete the requested table and sections based on the provided text. I will extract the information that is present and note where data is missing.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. Acceptance criteria for device performance (e.g., accuracy percentages, bias) are typically established for a clinical study and then compared against the device's measured performance. This document does not present such a table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary.
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):
This information is not present in the provided 510(k) summary. For glucose meters, ground truth is typically established by laboratory reference methods, not expert consensus in the same way it would be for imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided 510(k) summary. Adjudication is not typically applicable for objective measurements like glucose levels.
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:
This information is not present and is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic tools where human readers interpret images or data, with and without AI assistance. This device is a standalone glucose measurement system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described, ACCU-CHEK® Aviva Test Strips with the Aviva meter, is a standalone glucose measurement system. Its performance is inherent to the device itself and its interaction with a blood sample. A "standalone" study in the AI context refers to the algorithm's performance without human input, which could be considered analogous to the meter's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
While not explicitly stated in the provided text, for a glucose measurement device, the "ground truth" would typically be established by a laboratory reference method for glucose measurement (e.g., YSI analyzer, hexokinase method). The 510(k) summary does not specify this, but it is standard practice for such devices.
8. The sample size for the training set:
This information is not present in the provided 510(k) summary. This device is a traditional electrochemical sensor, not an AI/ML-based device that would require explicit "training data" in the same sense as an algorithm. Any "training" would be part of the R&D and calibration processes, not a distinct dataset for an algorithm.
9. How the ground truth for the training set was established:
This information is not present and is not applicable in the AI/ML sense of a "training set" for the reasons mentioned above.
Summary of available information:
The provided document is a 510(k) summary, which is a premarket notification to FDA. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results with specific acceptance criteria and the comprehensive study design requested.
Key information from the document related to performance/description:
- Intended Use: Quantitatively measure glucose in capillary, venous, arterial, and neonate samples (professional use); capillary whole blood (home use). For monitoring glucose in home or healthcare facilities.
- Reportable Range: 10 - 600 mg/dL
- Test Sample Volume: 0.6 µL
- Test Time: 5 seconds
- Hematocrit Range: 10 - 70% (Difference from predicate, which was 20-70%)
Without a separate, detailed performance study report, the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment (beyond the general understanding for a glucose meter) cannot be answered from this 510(k) summary.
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