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The Elecsys® Cortisol CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Cortisol assay.

The Elecsys® Cortisol CalCheck is a lyophilized product manufactured using a human serum base, synthetic cortisol, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

This document is a 510(k) premarket notification for the Elecsys® Cortisol CalCheck, a quality control material. It describes the device's indications for use, its substantial equivalence to a predicate device, and some performance characteristics. However, it does not contain the specific detailed information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria vs. performance, sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth.

Therefore, I cannot fulfill the request as the detailed information about acceptance criteria, study design, and performance metrics are not present in the provided text. The document is primarily a regulatory submission for substantial equivalence.

If this were a study report, the typical information would include:

1. A table of acceptance criteria and the reported device performance: This would list quantitative thresholds (e.g., accuracy > 95%, CV < 5%) and the actual values achieved by the device.
2. Sample size used for the test set and the data provenance: This would state the number of samples, their origin (e.g., specific hospitals, geographic regions), and whether the data was collected prospectively or retrospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would specify how many experts, their specialties (e.g., clinical chemists, endocrinologists), and their experience levels.
4. Adjudication method for the test set: This would describe the process of resolving disagreements among experts when establishing ground truth (e.g., a 2+1 system where two agree or a third expert decides, or simple majority).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: If applicable, this would detail the design of such a study and the measured improvement in human reader performance with the device's assistance.
6. If a standalone performance study was done: This would describe the results of the device operating independently without human intervention.
7. The type of ground truth used: For a quality control material, this might involve certified reference materials or established laboratory methods.
8. The sample size for the training set: (If it were an AI/ML device)
9. How the ground truth for the training set was established: (If it were an AI/ML device)

The document provided focuses on regulatory substantial equivalence, which assesses if a new device is as safe and effective as a legally marketed predicate device. It mentions "Performance Characteristics" related to "value assignment and stability" for the CalCheck, but does not provide the specific data or a study design.

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