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510(k) Data Aggregation
(62 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 Blood Glucose Monitor
The FDI Glucose Control Solution for FreeStyle 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 provided document is a 510(k) Premarket Notification for the "FDI Glucose Control Solution For FreeStyle," a quality control material, rather than a device that employs AI or requires extensive clinical studies with human readers. Therefore, several of the requested sections (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable to this type of submission.
However, I can extract the relevant information regarding acceptance criteria and performance studies for this specific product.
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic/Aspect | Acceptance Criteria (Predicate Device K102260) | Reported Device Performance (New Product) |
|---|---|---|
| Number of Levels | 1 | 1 |
| Analyte | Glucose | Glucose |
| Target (mg/dL) | 88 | 88 |
| Target Range (mg/dL) | 75 – 125 | 70-120 |
| Container | Plastic bottle with dropper-tip | Plastic bottle with dropper-tip |
| Fill Volume | 3.6 mL | 3.6 mL |
| Color | Red | Red |
| Matrix | Buffered aqueous solution of D-Glucose, a viscosity modifier, preservatives, and other non-reactive ingredients | Identical to Predicate 1, manufactured by FDI |
| Indications for Use | Used to check the performance of FreeStyle Lite Blood Glucose Systems. | Used to check the performance of FreeStyle Blood Glucose Systems. (Note: The new device is for "FreeStyle" monitors, while the predicate was for "FreeStyle Lite." This is a change in the specific system it's intended to check, but otherwise the type of use is the same). |
| Target Population | Professional and home use | Professional and home use |
Note: The acceptance criteria for the new device are primarily demonstrated by its similarity and equivalence to a previously cleared predicate device (K102260). The "Target Range" shows a slight adjustment (75-125 mg/dL to 70-120 mg/dL), which is likely a refined specification based on the FreeStyle system it's calibrated for. The performance studies mentioned below confirm that the new device meets its own specifications and is substantially equivalent.
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical trials with patient data, as this is a quality control solution. The performance was evaluated through:
- Stability studies: These typically involve testing the product over time under various conditions. The sample size would refer to the number of vials tested at different time points, but specific numbers are not detailed.
- Open Vial studies: Similar to stability, but specifically once the vial has been opened and exposed to air.
- Mean and Variance Comparison: This involves measuring the glucose concentration of the control solution repeatedly using the FreeStyle Blood Glucose Monitor and comparing the results to the established target and range. The number of replicates or individual tests performed is not explicitly stated.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by Fujirebio Diagnostics, Inc. (FDI) in the United States, given their address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control solution with a known chemical composition and target glucose concentration. Its "ground truth" is established by its formulation and analytical chemistry, not by expert interpretation of patient data.
4. Adjudication method for the test set
Not applicable. Ground truth for a quality control solution is based on its manufacturing specifications and analytical measurements, not a consensus of experts.
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 is a quality control solution, not an AI-powered diagnostic device, and does not involve human readers interpreting images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This product is a chemical solution, not an algorithm or software. Its performance is measured directly by how accurately it registers on the FreeStyle Blood Glucose Monitor when used by a human.
7. The type of ground truth used
The ground truth for the FDI Glucose Control Solution for FreeStyle is its known chemical concentration of glucose and its intended target range (70-120 mg/dL). This is established through its manufacturing process and analytical validation.
8. The sample size for the training set
Not applicable. As a chemical control solution, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this device.
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