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The Boehringer Mannheim Precinorm® TDM Controls are used to monitor accuracy and precision.

Precinorm® TDM is a triple range lyophilised control material based on human serum.
Precinorm® TDM is used for monitoring accuracy or precision.

The Boehringer Mannheim Precinorm® TDM Controls are manufactured using human serum albumin, therapeutic drugs, stabilizers, and preservatives. The analytes are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.

The Boehringer Mannheim Precinorm® TDM Controls are quality control materials used to monitor the accuracy and precision of therapeutic drug monitoring (TDM) assays. The study aims to demonstrate substantial equivalence to a predicate device, the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define quantitative "acceptance criteria" in a typical numerical format (e.g., specific accuracy percentages, precision coefficients of variation). Instead, the performance assessment relies on demonstrating "equivalent performance to the predicate device" in terms of dose assignment and stability.

Note: The document states, "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5." However, this attachment is not provided in the input, so quantitative performance metrics for dose assignment and stability are not extractable here. The claim of "equivalent performance" is the reported result.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for the test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective) for the performance characteristics. The focus of the provided text is on the substantial equivalence argument, rather than a detailed breakdown of a specific clinical study for the device's performance. The "performance characteristics" section is very brief, simply stating equivalence without presenting raw data or study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. As this device is a quality control material rather than a diagnostic device for patient samples, the concept of "ground truth" established by experts in the context of clinical reads (like radiologists) is not directly applicable. The "ground truth" for a control material would typically be its assigned value, which is determined through a value assignment process, often involving reference methods or comparison to established calibrators.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies where human readers are interpreting images or clinical data, which is not the nature of evaluating a quality control material.

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 information is not applicable and therefore not provided. This device is a quality control material and does not involve AI or human reader interpretation of diagnostic cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided. The device is a quality control material, not an algorithm, and the concept of "standalone performance" in this context is not relevant.

7. The Type of Ground Truth Used

For a quality control material like the Precinorm® TDM Controls, the "ground truth" is generally established through a value assignment process. The document states:

• "a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator."

This implies that the ground truth for the assigned values of the controls is based on established, highly characterized calibrators and potentially reference measurement procedures, ensuring traceability and accuracy.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the traditional sense of a "training set" for an AI algorithm. This device is a manufactured chemical control, not a machine learning model. The manufacturing process and value assignment would involve rigorous quality control and validation, but not a "training set" in the computational context.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" is not relevant here. The ground truth for the assigned values of the control material is established through a value assignment process involving comparison to analyte-specific and chemistry-specific calibrators. This process ensures that the reported concentrations for each analyte in the control are accurate and traceable.

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