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The QMS® Everolimus Assay is intended for the quantitative determination of Everolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations.
R1 Antibody Reagent:

Here's an analysis of the acceptance criteria and study findings for the Thermo Scientific QMS® Everolimus Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document does not explicitly state the total number of samples used for the "Method Comparison" study or for other performance tests like precision and linearity. It mentions "Everolimus samples were tested for precision" and "Samples were tested in the QMS® Everolimus Assay and compared to LC/MS."
• Data Provenance: The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of a drug in human whole blood. The "ground truth" for method comparison and analytical performance is established by comparison to a reference method (LC/MS) or by known concentrations of the analyte in manufactured samples (e.g., calibrators, controls). It does not involve human expert interpretation of images or clinical data.

4. Adjudication method for the test set

This is not applicable for this type of in-vitro diagnostic device. Analytical studies like method comparison and precision do not typically involve adjudication by 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 is not applicable. This device is an automated in-vitro diagnostic (IVD) assay, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study.

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

This is essentially how the device operates. The QMS® Everolimus Assay is an automated clinical chemistry assay that provides quantitative results. Its performance (analytical sensitivity, precision, method comparison) is evaluated in a standalone manner, meaning the assay itself generates the readings, which are then used by clinicians for patient management. There isn't a "human-in-the-loop" for the direct measurement process itself, although clinicians interpret the results.

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

The ground truth for the analytical performance studies appears to be:

• LC/MS (Liquid Chromatography/Mass Spectrometry): For the "Method Comparison" study, LC/MS served as the reference method for determining Everolimus concentrations.
• Known Concentrations: For studies like Analytical Sensitivity (LDD), Functional Sensitivity (LOQ), Precision, and Dilution Recovery, the ground truth would be based on precisely prepared samples with known concentrations of Everolimus (e.g., calibrators, controls, spiked samples).

8. The sample size for the training set

This information is not provided in the summary. For an IVD assay like this, there isn't a traditional "training set" in the sense of machine learning algorithms. Instead, assay development involves extensive testing and optimization using various formulations and spiked samples to establish performance characteristics, rather than a distinct training/test split of clinical data.

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

As noted above, a distinct "training set" with ground truth in the machine learning sense is not explicitly described or typically applicable for IVD assay development. The "ground truth" during development and optimization would involve using:

• Reference standards: Pure Everolimus used to create calibrators and controls with known concentrations.
• LC/MS analysis: As a highly accurate reference method to verify concentrations in samples during development.
• Spiked samples: Whole blood samples spiked with known amounts of Everolimus to assess recovery and other analytical parameters.

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