(64 days)
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of Accu-Chek Aviva Blood Glucose Monitor.
The FDI Glucose Control for Aviva consists of a viscosity-adjusted, aqueous liquid control solution containing a known quantity of glucose. The product is packaged in plastic dropper tipped bottles for easy application of the control solutions to the test strips and a red coloration to aid the user to visually confirm application of the control. The product is non-hazardous and contains no human or animal derived materials.
The information provided describes the FDI Glucose Control for Aviva, a quality control solution for the Accu-Chek Aviva Blood Glucose Monitor. As a control solution, its purpose is to ensure the proper functioning of the blood glucose meter. The available document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trial data that would typically feature in a drug approval or a more complex medical device requiring novel clinical evidence.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as you might see for a diagnostic's sensitivity and specificity. Instead, the performance studies for this control solution are based on stability and precision, and the comparison to the predicate device.
| Performance Characteristic | Predicate Device Acceptance/Performance (ACCU-CHEK Aviva Control Level 1) | New Product Performance (FDI Glucose Control for Aviva) | Stated Outcome |
|---|---|---|---|
| Analyte | Glucose | Glucose | Equivalent |
| Target Range (mg/dL) | 25 - 55 (Derived from manufacturer's assigned ranges) | 19 - 51 (Based on +/- 5% glucose variability lot-to-lot and +/- 15 mg/dL range) | Comparable |
| Number of Levels | 1 | 1 | Equivalent |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Equivalent |
| Fill Volume | 2.5 mL | 3.6 mL | Different |
| Color | Red | Red | Equivalent |
| Matrix | Glucose, buffer, salts, non-reactive ingredients, preservative, FD & C Blue #1 | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Similar |
| Intended Use | To check that the meter and test strips are working properly to give reliable results. | To check the performance of the ACCU-CHEK Aviva Blood Glucose System. | Equivalent |
| Target Population | Professional and home use | Professional and home use | Equivalent |
| Real Time Stability | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
| Open Vial Stability | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
| Test Precision | Not explicitly stated for predicate in comparison table | Tests performed to verify specific performance | Claimed equivalent |
The "Conclusion" section explicitly states: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." This implies that the performance in stability and precision tests was considered acceptable and comparable to the predicate device. However, specific numerical acceptance criteria for these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for the test set, nor does it specify the data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) summary for a control solution, where the focus is on chemical and physical properties rather than large-scale clinical trials involving patient data.
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 product is a control solution for a blood glucose monitor. The "ground truth" for such a device would typically be established by analytical chemistry methods to determine the precise glucose concentration within the control solution itself. This generally involves skilled laboratory technicians or chemists using reference methods, not clinical experts like radiologists. The document does not mention the number or qualifications of experts for establishing the ground truth of the control solution's glucose concentration.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations (e.g., image reads) require consensus among experts. For a control solution, performance is assessed based on objective analytical measurements (stability, precision, glucose concentration). Therefore, an adjudication method is not applicable and not mentioned.
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
An MRMC study is not applicable to a control solution. This type of study involves human readers (e.g., radiologists) interpreting cases, often with or without AI assistance, to assess diagnostic performance. The FDI Glucose Control for Aviva is a laboratory reagent used to verify the accuracy of a blood glucose meter, not a device that human readers interpret.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The FDI Glucose Control for Aviva is a physical solution; it does not contain an algorithm in the sense of AI or software that operates independently to produce a diagnostic output. Its "performance" is its intrinsic chemical stability and ability to elicit a correct response from the Accu-Chek Aviva meter within expected ranges.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a glucose control solution would be the actual, analytically determined concentration of glucose within the solution. This is established through rigorous laboratory testing using highly accurate and precise reference methods (e.g., isotope dilution mass spectrometry, enzymatic reference methods). The document does not explicitly state the specific method used to establish this inherent "ground truth" for the control solution, but it is implied by the nature of the product. The stated "Target Range (mg/dL)" for the new product (19-51 mg/dL) is "Based on a +/- 5% glucose concentration variability lot-to-lot and +/- 15 mg/dl range," indicating that the underlying glucose concentration is analytically defined.
8. The sample size for the training set
This question is not applicable as the FDI Glucose Control for Aviva is a chemical control solution, not an AI/ML algorithm or a device that requires a "training set" in the computational sense. Its performance is based on its chemical properties and manufacturing consistency.
9. How the ground truth for the training set was established
As there is no "training set" for this type of device, this question is not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.