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The Elecsys Toxo IgG 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 Toxo IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.

The Elecsys Toxo IgG CalCheck 5 is a lyophilized product consisting of a defined concentration of human anti-Toxoplasma gondii IgG antibodies in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys Toxo IgG CalCheck 5, an assayed control device used for calibration verification and assay range verification for Elecsys Toxo IgG reagent on specific immunoassay analyzers.

Here's an analysis to extract the requested information:

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

The document states: "Each laboratory should establish appropriate acceptance criteria when using this product for its intended use." It then provides "approximate target ranges" and instructs to "Refer to the value sheet located on www.MyLabOnline.com for lot-specific ranges."

Therefore, the acceptance criteria are to be established by individual laboratories, and the reported device performance is presented as target ranges.

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

The document implicitly describes "test sets" as the use of the CalCheck 5 levels themselves for verification.

• For calibration verification only, "recommended levels are Check 2, 3 and 4." Each level is run in duplicate. This forms a test set of 6 samples (3 levels x 2 replicates).
• For verification of assay range (or both assay range and calibration verification), "recommended levels are Check 1, 2, 3, 4 and 5." Each level is run in duplicate. This forms a test set of 10 samples (5 levels x 2 replicates).

The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it is a submission for a 510(k) in the US, it's reasonable to infer data would support US regulatory requirements, but it's not explicitly stated. It describes instructions for how a user should run the checks, rather than detailing a specific pre-market study's data provenance.

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 device is a control material, not a diagnostic device that interprets patient data. The "ground truth" for the test set (the CalCheck 5 solutions) is their assigned value, which is traceable to an international standard. The document states: "The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK." Therefore, the ground truth is established against a recognized international standard, not by experts in the sense of clinical interpretation.

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

Not applicable. This is a control material for laboratory calibration and assay range verification, not a diagnostic device requiring human adjudication of results. The method of verification involves comparing the average value of duplicate runs to a specified acceptable range provided in a lot-specific value sheet. If results are outside the range, troubleshooting steps are outlined (repeat testing, contact technical support).

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 control material for calibration and assay range verification in an immunoassay system. It does not involve human readers interpreting cases or AI assistance.

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

Not applicable. This is a physical control material used in conjunction with an immunoassay analyzer and reagents. It's not a standalone algorithm.

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

The ground truth for the Elecsys Toxo IgG CalCheck 5 levels is primarily traceability to an international standard: "The assay value of each level was calibrated against the WHO anti-Toxoplasma serum (TOXM), 3rd International Standard for T. gondii from NIBSC, UK."

8. The sample size for the training set

Not applicable. This is a control material, not a machine learning model that requires a training set. Its values are assigned through calibration to a reference standard during manufacturing.

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

Not applicable for the same reason as above.

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