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510(k) Data Aggregation
(189 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 the BREEZE 2 Blood Glucose Monitor.
The FDTX Glucose Control Solution 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.
Here's a breakdown of the acceptance criteria and study information for the FDTX Glucose Control Solution based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated table format with corresponding reported performance values for each criterion. Instead, it outlines the general characteristics of the device and compares them to predicate devices, and then lists the types of performance studies conducted. The implication is that the performance of the FDTX Glucose Control Solution was found to be comparable or acceptable relative to the predicate devices and industry standards for these types of control solutions.
| Acceptance Criteria Category/Characteristic | Reported Device Performance (as implied by comparison to predicates and study types) |
|---|---|
| Intended Use | For in vitro diagnostic use by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Bayer Ascensia BREEZE 2 Blood Glucose Monitor. (Matches predicate's function for a specific glucose monitor). |
| Levels of Control | 1 level of control (Matches predicate devices). |
| Analyte | Glucose (Matches predicate devices). |
| Target (mg/dL) | 100 mg/dL (Matches predicate devices). |
| Target Range (mg/dL) | 85 - 130 mg/dL (Matches Predicate Device No. 1, different from Predicate Device No. 2, but likely within acceptable range for the intended use and specific meter). |
| Container | Plastic bottle with dropper-tip (Matches predicate devices). |
| Fill Volume | 3.6 mL (Matches Predicate Device No. 2, different from Predicate Device No. 1, but likely acceptable). |
| Color | Red (Matches Predicate Device No. 2, different from Predicate Device No. 1, but this is a visual aid and not a performance criterion). |
| Matrix | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients (Similar to predicate device composition). |
| Stability | "Tests were performed to verify specific performance characteristics: Stability." (Implies satisfactory stability was demonstrated, though no specific numerical acceptance range or duration is provided). |
| Open Vial Stability | "Tests were performed to verify specific performance characteristics: Open Vial." (Implies satisfactory open-vial stability was demonstrated, though no specific numerical acceptance range or duration is provided). |
| Test Precision | "Tests were performed to verify specific performance characteristics: Test precision." (Implies satisfactory precision was demonstrated, though no specific numerical acceptance limits or results are provided). |
2. Sample size used for the test set and the data provenance:
- The document does not specify the sample size used for the test set (number of measurements, number of vials, etc.) for stability, open vial, or precision studies.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given the context of a 510(k) submission for a control solution, these studies would typically be prospective and conducted internally by the manufacturer, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided for this device. The device is a "Glucose Control Solution," which is a diagnostic reagent used to verify the performance of a blood glucose monitor. Ground truth for such a control solution is established by its manufactured concentration and subsequent assay/calibration against reference methods, not by expert interpretation. Experts are not directly involved in establishing the "ground truth" of the control solution itself.
4. Adjudication method for the test set:
- This information is not applicable and not provided. As explained above, expert adjudication is not relevant for establishing the "ground truth" or performance of a glucose control solution.
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 applicable. The device is a glucose control solution, not an AI-powered diagnostic tool, and involves no human interpretation of medical images or data that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical control solution, not an algorithm, so the concept of standalone algorithmic performance doesn't apply.
7. The type of ground truth used:
- The ground truth for a glucose control solution is the known, manufactured, and independently verified concentration of glucose within the solution, established through rigorous chemical assays and calibration against reference standards. The document states the solution contains a "known quantity of glucose" and has a "Target (mg/dL)" of 100. This known concentration serves as the ground truth.
8. The sample size for the training set:
- This information is not applicable and not provided. This device is not an AI algorithm that requires a "training set" in the conventional sense. The development of such a control solution involves chemical formulation, analytical testing, and process validation, not machine learning model training.
9. How the ground truth for the training set was established:
- This information is not applicable. As stated above, there is no "training set" for this type of device. The ground truth (known glucose concentration) for the product itself is established through chemical manufacturing and analytical testing procedures.
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