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The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay.

The Elecsys® CalCheck™ AFP is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

This document does not contain the detailed information necessary to answer your request. It's a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ AFP), which is a laboratory control, not a diagnostic device that would typically undergo the kind of performance studies you're asking about (e.g., studies with human readers, ground truth consensus, etc.).

The document focuses on:

• Device Name and Intended Use: The Elecsys® CalCheck™ AFP is used to verify the calibration of the Elecsys AFP assay.
• Predicate Device Comparison: It establishes substantial equivalence to a previously marketed calibration material (Elecsys® CalCheck™ TSH).
• Description: It's a three-level set of lyophilized, human-based materials to be assayed in triplicate.

The "Performance Characteristics" section is introduced but the actual details are cut off. However, even if they were present, for a calibration verification material, typical "performance" would involve things like:

• Value Assignment: How accurately the assigned values for the control material are determined.
• Stability: How long the lyophilized material and reconstituted material remain stable within specifications.
• Homogeneity: Ensuring consistent concentration throughout the material.
• Lot-to-lot consistency: Ensuring different manufacturing lots perform similarly.

It would not involve:

• A test set with ground truth established by experts.
• MRMC studies to evaluate human reader improvement.
• Standalone algorithm performance in a diagnostic context.

Therefore, I cannot provide the requested information based on the provided text.

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The Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.

The Elecsys® CalCheck™ CEA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

This is a pre-AI/ML device, and the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance. The device is a calibration verification material for an immunoassay. Therefore, I cannot fulfill your request based on the provided input.

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