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The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.

The provided text describes a Thyroid Calibrator, a liquid bovine albumin-based product designed for calibrating FT4 and TSH methods on the Dimension® RxL clinical chemistry system. The document is a "Summary of Safety and Effectiveness Information" for a 510(k) submission, indicating a comparison to a predicate device for substantial equivalence.

However, the document does not contain information related to acceptance criteria or a study proving device performance in the way requested by the prompt. This document is a summary of safety and effectiveness information and focuses on comparing the new device to a predicate device to establish substantial equivalence, not on detailed performance validation studies with acceptance criteria, sample sizes for test sets, ground truth establishment, or clinical effectiveness studies.

Specifically, the requested information elements are not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document compares features of the new calibrator to predicate calibrators but does not define or report performance against specific acceptance criteria for accuracy, precision, or other analytical characteristics.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a calibrator, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a calibrator.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document's purpose is to argue for substantial equivalence based on intended use, analytes, matrix, form, volume, and levels, not to report on detailed performance studies against pre-defined acceptance criteria.

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