(21 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 FreeStyle and FreeStyle Lite Blood Glucose Monitors.
The AbT 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 nonhazardous and contains no human or animal derived materials.
Here's a breakdown of the acceptance criteria and the study information for the KCJ3549 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Predicate Device No. 1 (FreeStyle Control Solution) | Predicate Device No. 2 (Liberty Glucose Control) | New Product (AbT Glucose Control Solution) |
|---|---|---|---|
| Analyte | Glucose | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 | 88 |
| Target Range (mg/dL) | 80 - 130 | 80 - 130 | 80 - 130 |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 4.0 mL | 3.6 mL | 3.6 mL |
| Color | Red | Red | Red |
| Matrix | Buffered aqueous solution of D-Glucose, viscosity modifier, preservatives, and other non-reactive ingredients | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 2 |
| Indications for Use | For use with the FreeStyle blood glucose monitoring system in order to ensure that the FreeStyle meter and FreeStyle test strips are working properly. | Used to check the performance of FreeStyle Blood Glucose Systems. | Used to check the performance of FreeStyle and FreeStyle Lite Blood Glucose Systems. |
| Target Population | Professional and home use | Professional and home use | Professional and home use |
| Stability | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met stability. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met stability. | Performance verified (implied to meet similar standards). |
| Open Vial | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met open vial. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met open vial. | Performance verified (implied to meet similar standards). |
| Mean and Variance Comparison | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met mean/variance comparison. | Not explicitly stated in table, but performance was verified for predicate, implying the new product also met mean/variance comparison. | Performance verified (implied to meet similar standards). |
Study that Proves the Device Meets Acceptance Criteria:
The document states: "Performance Studies: Tests were performed to verify specific performance characteristics: 1. Stability 2. Open Vial 3. Mean and Variance Comparison."
The conclusion is: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence."
This indicates that the AbT Glucose Control Solution was subjected to these performance studies, and the results demonstrated that it met the necessary criteria, leading to the determination of substantial equivalence to the predicate devices. The acceptance criteria themselves are primarily defined by the characteristics of the predicate devices (e.g., target range, fill volume, matrix, intended use) to which the new device is compared. The specific acceptance thresholds for "Stability," "Open Vial," and "Mean and Variance Comparison" are not detailed in this summary but are implicit in the performance verification.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set in the performance studies (Stability, Open Vial, Mean and Variance Comparison).
The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The device is a "Quality Control Material," and its "ground truth" would typically refer to the measured glucose concentration within the control solution itself, established through analytical methods rather than expert consensus on diagnostic images or patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. For a glucose control solution, the performance is assessed through quantitative measurements against established standards.
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
There was no MRMC comparative effectiveness study done. This type of study involves human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on human performance. The device in question, an AbT Glucose Control Solution, is a quality control material and not an AI-powered diagnostic device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a chemical control solution, not an algorithm or AI system.
7. The Type of Ground Truth Used
For a glucose control solution, the "ground truth" is the known, assayed concentration of glucose within the solution itself. This would be established through laboratory analytical methods (e.g., reference methods for glucose measurement). The document implicitly refers to this "target" glucose level (88 mg/dL) and "target range" (80-130 mg/dL).
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a manufacturing product (a glucose control solution), not an AI algorithm that requires a training set. The "formulation" is the key aspect, not a statistical training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.