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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 Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

The SMS Multi Glucose Control 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 document is a 510(k) summary for the SMS Multi Glucose Control device. It details the device's characteristics, intended use, and comparison to predicate devices. However, the document does not contain specific acceptance criteria, reported device performance metrics, or detailed study results (sample sizes, ground truth establishment, expert qualifications, etc.) in the format requested.

The "Performance Studies" section only lists categories of tests performed (Stability, Open Vial, Microbial Stress Stability, Test precision) without providing any data or specific criteria for these tests. The "Conclusion" states that "Comparison of the performance characteristics, formulation and intended use support the claim of substantial equivalence," but again, no specific performance data is presented.

Therefore, for aspects requiring quantitative data, specific study design details, or expert involvement, the information is not available in the provided text.

Here is the information that can be extracted or explicitly stated as not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample size for test set: Not specified in the document.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of experts: Not specified in the document.
• Qualifications of experts: Not specified in the document.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Adjudication method: Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable/Not mentioned. This device is a quality control solution for blood glucose monitors, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not mentioned. This device is a control solution, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not specified in the document. For a quality control solution, ground truth would typically refer to the known concentration of the analyte (glucose) in the control solution, established through a traceable reference method. However, the document does not explicitly state how this "ground truth" was established for the performance studies.

8. The Sample Size for the Training Set

• Not applicable/Not mentioned. This device is a quality control solution, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not mentioned. This device is a quality control solution, not a machine learning algorithm requiring a training set and corresponding ground truth.

In summary, the provided 510(k) summary focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria and ground truth methodologies. For a device like a glucose control solution, the "performance studies" would likely involve laboratory testing to verify concentration, stability, and precision. However, the document does not elaborate on the specific methodologies or results of these tests.

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