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The Rubella IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum. The test is intended to be used to evaluate serologic evidence of primary or active infection with Rubella and is for in vitro diagnostic use.

The Aptus (automated) Application of the Rubella IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum.

The provided document is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the Rubella IgM ELISA." This letter grants clearance for the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.

The 510(k) letter states that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a review of information submitted by the manufacturer to the FDA, which would have included performance data. However, the specific details of that performance data, the acceptance criteria used, and the study design are not present in the provided text.

Therefore, I cannot fulfill your request for the following information based solely on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not in the document.
2. Sample size used for the test set and the data provenance: Not in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not in the document.
4. Adjudication method for the test set: Not in the document.
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 in the document. This is also for an in vitro diagnostic device, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not in the document, and likely not applicable in the context of an ELISA assay.
7. The type of ground truth used: Not in the document. For an ELISA, this would typically involve reference methods or confirmed clinical status.
8. The sample size for the training set: Not in the document. The concept of a "training set" in the context of an ELISA assay is different from that of machine learning algorithms.
9. How the ground truth for the training set was established: Not in the document.

To obtain this information, you would need to access the full 510(k) submission (K984180) made to the FDA by Zeus Scientific, Inc., which is typically a much more detailed document than the clearance letter.

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