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The Vigil™ HbA1c Controls are designed for monitoring the overall reliability of HbA1c assays on SYNCHRON CX® and LX™ Systems.

The Beckman Vigil Hemoglobin A1c (HbA1c) Controls are designed for monitoring the reliability and overall performance of Beckman Hemoglobin A1c (HbA1c) test systems in the clinical laboratory. The use of two levels of control allows the laboratorian to monitor analytical error and imprecision.

The Vigil HbA1c Controls are a two level lyophilized control set made from hemolyzed human and ovine blood. Each kit contains 3 X 1 mL bottles of each specific level of control. The levels are identified as Vigil HbA1c Control Level 1, and Vigil HbA1c Control Level 2. The products require reconstitution with exactly 1.0 mL of distilled water prior to use. The lyophilized products must be stored at +2℃ to +8℃ when not in use. The reconstituted controls are stable for 1 week at +2℃ to +8℃, 8 hours at +20℃ to +25℃, and 3 months when stored frozen between -15℃ to -20℃.

The provided text is a 510(k) summary for the Beckman Coulter VIGIL™ HbA1c Controls, a quality control material. It details the device's description, intended use, and comparison to a predicate device, as well as a summary of performance data. However, the document does not describe specific acceptance criteria (numerical targets for performance metrics) or a detailed study proving the device meets those criteria in a way that aligns with the questions posed. The performance data section is very brief and focuses solely on stability studies, not on the precision or accuracy of the controls in monitoring HbA1c assays.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: The document only provides data on "Stress stability studies of the lyophilized Vigil HbA1c Controls," and the conclusion is that these support a "Beckman stability claim of 24 months." No performance metrics like precision (e.g., CV%) or accuracy (e.g., bias) for the controls themselves when used in an HbA1c assay are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The stability study mentions "Duration of Incubation" but not the number of samples tested at each duration.
• Data Provenance: Not specified. The document is from Beckman Coulter, Inc. in Brea, California, USA, but it does not state where the study was conducted or the origin of the materials beyond being "hemolyzed human and ovine blood." Whether it was retrospective or prospective is also not mentioned.

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. This device is a quality control material, not an diagnostic algorithm requiring expert interpretation of results to establish ground truth for a test set. The performance data is solely related to the stability of the control material itself.

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 is a quality control material, not an AI-assisted diagnostic device involving human readers.

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

• Not applicable. This is a quality control material, not a standalone algorithm/device in that sense. Its "performance" is in its stability and its ability to provide known values for monitoring other assays.

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

• For the stability study, the "ground truth" would be the known concentration of HbA1c in the control material at the beginning of the study, and subsequent measurements taken over time would be compared to this initial value (or a derived expected value) to assess stability within acceptable ranges (which are not specified). There is no mention of expert consensus, pathology, or outcomes data used for this control material.

8. The sample size for the training set

• Not applicable. This is a quality control material and does not involve machine learning or a "training set."

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

• Not applicable. See point 8.

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