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The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.

For In Vitro Diagnostic Use.

The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. The assay consists of reagents, sample extract and calibrator.

The provided text describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Tacrolimus Assay Kit" (candidate device) to a predicate device, the ARCHITECT Tacrolimus Assay.

Here's an analysis of the requested information:

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

The document does not explicitly list "acceptance criteria" in a structured table with direct performance targets. Instead, it states that "Analytical studies were performed to evaluate the precision, linearity, assay reportable range, recovery, specificity, and accuracy of the candidate device." The conclusion then states that these tests demonstrate "substantial equivalence." This implies that the performance in these areas met thresholds considered acceptable for substantial equivalence to the predicate device.

However, a key difference between the candidate and predicate device is the "Measuring Range." This could be considered a performance characteristic with an implicit acceptance criterion that the range should be clinically relevant and comparable to other devices.

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 does not provide details on the sample size used for the analytical studies (precision, linearity, etc.), nor does it specify the data provenance (country of origin, retrospective/prospective). It simply states that "Analytical studies were performed."

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 this type of device (Tacrolimus Assay Kit). The "ground truth" for an in-vitro diagnostic test like this is established through reference methods or highly accurate analytical techniques, not through expert consensus on images or clinical assessments.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology studies). For an in-vitro diagnostic assay, the "adjudication" would involve rigorous laboratory protocols, quality control, and comparison to established reference materials or methods, not human adjudication between experts.

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 device is a Tacrolimus Assay Kit, an in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This question is not applicable in the context of "algorithm only" as typically understood for AI/CAD devices. However, the performance assessment described (precision, linearity, accuracy, etc.) is essentially "standalone" in the sense that it evaluates the kit's performance on its own, independent of human interpretation or intervention beyond standard laboratory procedures for running the assay. It's a laboratory test, not an AI algorithm.

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

For in-vitro diagnostic assays, "ground truth" is typically established by:

• Reference materials/standards: Samples with known concentrations of tacrolimus, often certified.
• Reference methods: Highly accurate and validated laboratory methods (e.g., mass spectrometry) used to determine the true concentration in patient samples.
• Split-sample comparison: Comparing results from the candidate device to a legally marketed predicate or other established method using the same patient samples.

The document implicitly refers to these by stating the studies evaluated "precision, linearity, assay reportable range, recovery, specificity, and accuracy." Accuracy, for instance, would be assessed against known values from reference methods or materials.

8. The sample size for the training set

This question is not applicable. The device is an in-vitro diagnostic assay based on a chemical/immunological reaction, not a machine learning model that requires a "training set" in the conventional sense.

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 device.

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