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The OPUS B12 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS B12 assay.

The OPUS B12 Controls are liquid controls containing known levels of human Vitamin B12 (Cyanocobalamin) in processed Human Serum Albumin with sodium azide as a preservative. The control is provided at three levels (low, mid and high). The OPUS B12 Control is only for use with the OPUS B12 assay and has not been evaluated for use with other assays.

The provided text describes a 510(k) summary for OPUS B12 Controls, which are quality control materials. The information is focused on demonstrating the precision of these controls, not on validating a diagnostic device's ability to detect or diagnose a condition. Therefore, many of the requested categories in the prompt (e.g., "acceptance criteria and reported device performance" as typically applied to diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "stand-alone study," "type of ground truth" for diagnosis, "training set size") are not applicable or cannot be extracted from this document as the device in question is a quality control material and not a diagnostic algorithm.

However, I can extract information related to the device's performance as a control material, which is precision.

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

Study Proving Device Meets Acceptance Criteria (Precision Study):

• Study Design: The precision of the OPUS B12 Controls was evaluated using an OPUS Immunoassay System with the OPUS B12 assay.
  • Intra-assay precision: Evaluated by running n=18 for each level of the OPUS control.
  • Inter-assay precision: Evaluated by running duplicate determinations for each level of control twice per day (AM and PM) for five days, totaling an n=20.

2. Sample size 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:
  • Intra-assay: n=18 for each control level (low, mid, high).
  • Inter-assay: n=20 for each control level (duplicate determinations over 5 days).
• Data Provenance: Not specified, but given it's a product from Behring Diagnostics, Inc. in Westwood, MA, it's likely U.S.-based. The study appears to be prospective, as it involved actively running the controls.

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 a diagnostic algorithm that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for a control material is its precisely manufactured concentration of the analyte, which is then measured for precision.

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 product, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a quality control product, not a diagnostic algorithm.

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

• The "ground truth" for these controls would be the known, manufactured concentrations of Vitamin B12 within the control materials at each level (low, mid, high). The study evaluated how precisely the OPUS B12 assay measured these known concentrations.

8. The sample size for the training set

• Not Applicable. This product is a control material and does not involve an algorithm that requires a training set.

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

• Not Applicable. See point 8.

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