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The Toxoplasma IgM ELISA test system provides a means for the manual and/or automated (Aptus), presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum and for the presumptive diagnosos of acute, recent, or reactive infection. To adequately assess the patient's serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. The assay's performance has not been established for screening of prenatal women or newborns.

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The provided document is a 510(k) premarket notification approval letter for "The Aptus (automated) Application for the Toxoplasma IgM ELISA Test System." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be necessary to fill out the requested table and answer the specific questions about the device's performance, sample sizes, ground truth establishment, or multi-reader studies. The document is an administrative approval letter, not a scientific study report.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, the actual 510(k) submission (which would contain the performance studies) would need to be reviewed.

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