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The Elecsys Digoxin CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Digoxin reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Digoxin CalCheck 5 is a liquid product consisting of Digoxin in a buffer/protein (bovine serum) matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

This submission K102044 is for the Elecsys Digoxin CalCheck 5, which is an assayed control for use in calibration verification and for verifying the assay range of the Elecsys Digoxin reagent on Elecsys and cobas e immunoassay analyzers.

It's important to note that this document describes a Quality Control Material (QCM), not an AI/ML-driven medical device for diagnosis or treatment. Therefore, many of the typical acceptance criteria and study designs associated with AI devices (like ROC curves, sensitivity/specificity, human reader studies, etc.) are not applicable here.

The "device" in this context is a control material that ensures the accuracy and reliability of an analysis instrument (Elecsys and cobas e immunoassay analyzers) when measuring Digoxin. The "performance" of this control material is primarily related to its value assignment (i.e., whether the stated Digoxin concentrations are accurate) and its stability over time.

Here's an attempt to answer your questions based on the provided text, recognizing the nature of the device:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format for the CalCheck 5, nor does it provide detailed "reported device performance" metrics beyond the statement that it "was evaluated for value assignment and stability."

However, based on the nature of a quality control material, the implicit "acceptance criteria" would be that the assigned values are accurate within a specified tolerance and that the material remains stable for its shelf life.

Implicit Acceptance Criteria (for a Quality Control Material):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided 510(k) summary does not contain information about the sample size (number of batches, vials, or measurement replicates) used for the testing of "value assignment and stability." It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

For a quality control material, "test set" would typically refer to a defined number of batches of the product, tested across various instruments and conditions. This detail is not present.

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)

This question is not applicable to the Elecsys Digoxin CalCheck 5.

• Ground Truth for a QCM: For a quality control material like this, the "ground truth" for the analyte concertation is established during the manufacturing process by spiking a known amount of analyte into the matrix and verifying it using highly accurate reference methods, often traceable to international standards. It's not typically established by human experts or clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to the Elecsys Digoxin CalCheck 5. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers (e.g., radiologists) interpret images or data and their disagreements need to be resolved. This device is a chemical control standard, not an interpretive tool.

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 question is not applicable. The Elecsys Digoxin CalCheck 5 is a quality control material, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are entirely irrelevant to this product.

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

This question is not applicable. The Elecsys Digoxin CalCheck 5 is a physical chemical product, a quality control material containing a known concentration of Digoxin. It does not involve an "algorithm" or standalone "performance" in the way AI devices do. Its performance is evaluated by its ability to reliably verify calibration and assay ranges on immunoassay analyzers.

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

As mentioned in point 3, the "ground truth" for the Elecsys Digoxin CalCheck 5's labeled concentrations is established by precise manufacturing processes involving the spiking of a known amount of Digoxin into the bovine serum matrix, followed by rigorous analytical testing using reference methods and traceability to ensure accuracy. It does not rely on expert consensus, pathology, or outcomes data, which are typical for diagnostic devices.

8. The sample size for the training set

This question is not applicable. The Elecsys Digoxin CalCheck 5 is a manufactured chemical product, not a software algorithm that is "trained" on data. Therefore, there is no "training set."

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

This question is not applicable, as there is no "training set" for this type of product.

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