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The Elecsys® proBNP CalCheck is intended for use in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

The Elecsys® proBNP CalCheck is a lyophilized product manufactured using proBNP in human serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels.

The provided 510(k) summary for the Elecsys® proBNP CalCheck does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the format requested.

This document describes a "Calibration Verification Material" and its intended use is to verify the calibration of an immunoassay system. The 510(k) process for such a device typically focuses on demonstrating substantial equivalence to a predicate device and validating certain performance characteristics like value assignment and stability, rather than setting specific clinical performance acceptance criteria like sensitivity or specificity.

Here's a breakdown of the information that could be extracted and what is explicitly missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Implicit for this type of device): The primary implicit acceptance criteria for a calibration verification material would be its ability to consistently produce expected values within a defined range when tested on the intended immunoassay analyzers, and its stability over its shelf life. However, no specific numerical acceptance criteria (e.g., ±X% deviation from target value, or stability within Y%) are stated in the provided text.
• Reported Device Performance:
  • "The Elecsys® proBNP CalCheck was evaluated for value assignment and stability."
  • This statement confirms these evaluations were performed, but no quantitative results (e.g., actual assigned values, observed stability data, or precision data) are reported.

Summary Table (Based on available information in the document):

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

• Test Set Sample Size: Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. The "ground truth" for a calibration verification material would typically be its manufacturing-assigned concentration, determined through highly controlled analytical methods, not through expert consensus on cases.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or complex diagnostic outcomes.

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

• This information is not applicable and not provided. The Elecsys® proBNP CalCheck is a calibration verification material, not an AI-assisted diagnostic device.

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

• This information is not applicable and not provided. The device is a physical calibration material, not an algorithm.

7. The type of ground truth used

• For this type of device, the "ground truth" for the proBNP concentrations in the CalCheck solutions would be their assigned analytical values, established during manufacturing using reference methods and materials, which ensures accuracy and traceability. The document states: "The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels." and "Elecsys® proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration."

8. The sample size for the training set

• This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set.

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

• This information is not applicable and not provided.

In summary: The provided 510(k) summary is for a calibration verification material, not a diagnostic or AI-powered device that would typically involve the comprehensive clinical study details requested. The focus for this type of device is on demonstrating manufacturing quality, analytical performance (value assignment, stability), and equivalence to a predicate. Most of the requested comparative effectiveness and expert-driven ground truth details are not relevant to this specific product.

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