(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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.