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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 TrueTrack®, TrackEASE® and TRUEread™ meters and test strips.

The FDI Glucose Controls consist of a viscosityadjusted, aqueous liquid control solutions containing known quantities 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 document is a 510(k) Premarket Notification for FDI Glucose Controls. This type of document is for in-vitro diagnostic devices (like control solutions for glucose meters), not for AI/ML-driven medical imaging devices or other software-as-a-medical-device that typically require the detailed performance metrics asked for in the prompt.

Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document, as they pertain to clinical efficacy studies for disease diagnosis/prognosis, which are not relevant for a glucose control solution.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

For a control solution, acceptance criteria are typically related to stability and precision, ensuring the control solution itself provides consistent and accurate results for its intended purpose (checking the performance of glucose meters). The document focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit "acceptance criteria" in the context of diagnostic accuracy for a disease.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document indicates "Tests were performed to verify specific performance characteristics," but does not detail the number of runs, measurements, or individual control solution samples used for each test.
• Data Provenance: Not explicitly stated. Assuming internal laboratory testing by Fujirebio Diagnostics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This device is a control solution. Ground truth typically refers to a definitive diagnosis or outcome for a patient, which is not applicable here. The "ground truth" for a control solution would be its known glucose concentration, established through highly accurate analytical methods, not expert clinical interpretation.

4. Adjudication method for the test set:

• N/A. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in diagnostic tasks. This is not relevant for a control solution's performance testing.

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:

• N/A. This study relates to the performance of a glucose control solution, not a diagnostic AI system with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A. This device is a control solution, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the control solution, the "ground truth" for its performance testing would be the known and analytically determined concentrations of glucose within the control solution. This is established through rigorous laboratory methods, not clinical expert consensus or pathology.

8. The sample size for the training set:

• N/A. This device is a control solution. It does not involve a "training set" in the context of machine learning. The stability and precision studies are the "performance studies" for this type of device.

9. How the ground truth for the training set was established:

• N/A. (See point 8).

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