(45 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 Lite Blood Glucose Monitor.
The FDI 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.
The provided text describes a 510(k) premarket notification for the FDI Glucose Control Solution, a quality control material used with the FreeStyle Lite Blood Glucose Monitor. It does not describe a medical device that uses AI or performs any diagnostic function independently.
Therefore, many of the requested sections are not applicable to this document as they pertain to studies for diagnostic devices, particularly those involving AI or human interpretation.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical diagnostic study with sensitivity, specificity, etc. Instead, it aims to demonstrate substantial equivalence to a predicate device. The performance characteristics compared are:
| Characteristic/Aspect | Predicate Device No. 1 (AbT Glucose Control Solution) | New Product (FDI Glucose Control Solution) | Acceptance and Performance |
|---|---|---|---|
| Target (mg/dL) | 88 | 88 | Met: Identical target |
| Target Range (mg/dL) | 80 – 130 | 75 - 125 | Met: A specific range is defined for both, although the new product has a slightly narrower range, it's within expected control variations. The document notes the predicate's range was for "Liberty Glucose Control" (possibly an earlier version or related product). |
| Formulation (Matrix) | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 1 | Met: Stated as identical. |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip | Met: Identical container. |
| Fill Volume | 3.6 mL | 3.6 mL | Met: Identical fill volume. |
| Color | Red | Red | Met: Identical color. |
| Intended Use | Used to check the performance of FreeStyle and FreeStyle Lite Blood Glucose Systems. | Used to check the performance of FreeStyle Lite Blood Glucose Systems. | Met: Similar intended use, specifically refined to FreeStyle Lite. |
Study that Proves Device Meets Acceptance Criteria:
The "Performance Studies" section (Section 2) mentions:
- Stability
- Open Vial
- Mean and Variance Comparison
The conclusion states: "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence." This implies that these studies demonstrated that the FDI Glucose Control Solution performed comparably to its predicate device across these aspects. However, specific numerical results or detailed methodology for these studies are not provided in the extracted text.
The following points are not applicable to this document as it describes a simple control solution, not a diagnostic device involving AI, human interpretation, or complex clinical outcome studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a control solution, and the "performance studies" are likely laboratory-based characterization, not a clinical trial with patient data or test sets in the typical sense.
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)
- Not applicable. Ground truth for a glucose control solution is established by its chemical composition and manufacturing specifications, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- Not applicable. This device does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a control solution, the "ground truth" for its characteristics (e.g., glucose concentration, pH, stability) is established by analytical chemistry and manufacturing standards and specifications.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See 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.