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510(k) Data Aggregation
(499 days)
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
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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