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The OPUS CK-MB & Total CK Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS CK-MB and Total CK assay.

The OPUS CK-MB & Total CK Controls are bovine calf serum based controls consisting of three levels (low, mid and high) containing known levels of human CK-MB and rabbit skeletal CK

This 510(k) premarket notification describes the OPUS CK-MB & Total CK Controls, which are quality control materials, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories are not applicable.

Here's an adaptation of the requested information for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" values in the traditional sense for diagnostic devices. Instead, it reports the precision performance. For quality control materials, the expectation is generally that the precision falls within acceptable ranges for laboratory use, often defined internally by the manufacturer or by regulatory guidance for QC materials.

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

• Intra-assay precision: n=20 for each level of the OPUS controls.
• Inter-assay precision: Duplicate determinations for each level of control, run twice per day (AM and PM) for five days, totaling n=20.
• Data Provenance: Not explicitly stated, but assumed to be prospective data collected by Behring Diagnostics Inc. for the purpose of this submission (manufacturer data). Country of origin is not specified.

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 material. Its "ground truth" relates to its inherent chemical stability and concentration, which is determined by analytical methods during manufacturing, not by expert interpretation.

4. Adjudication method for the test set:

• Not Applicable. As a quality control material, there is no "adjudication" of results in the clinical sense. The performance is based on analytical precision.

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 a diagnostic device, and does not involve human readers or AI assistance.

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 an algorithm or an AI device. The "performance" is its analytical precision.

7. The type of ground truth used:

• For quality control materials, the "ground truth" (or target values) for CK-MB and Total CK levels in the controls are established during the manufacturing process through chemical analysis and calibration, likely against reference materials. The document states they contain "known levels of human CK-MB and rabbit skeletal CK."

8. The sample size for the training set:

• Not Applicable. This is a quality control material; there is no "training set" in the context of machine learning or diagnostic algorithm development. Its characteristics are determined by manufacturing and quality assurance processes.

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

• Not Applicable. See point 8.

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