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The Beckman Vigil Therapeutic Drug Monitoring (TDM) Controls are designed for monitoring the reliability and overall performance of Beckman Therapeutic drug test systems in the clinical laboratory. The use of three levels of control allows the laboratorian to monitor change in calibration along with analytical error and imprecision.

The VIGIL™ TDM Controls are tri-level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 3 X 3 mL bottles of a specific level of control. The levels are identified as Vigil TDM Control Level 1, Vigil TDM Control Level 2, and Vigil TDM Control Level 3. The products require no preparation prior to use and must be stored at +2° C to +8°C when not in use.

The provided text describes the Beckman VIGIL™ TDM Controls, which are clinical toxicology control materials. The study presented focuses on the stability of these controls rather than a functional performance study with a diagnostic algorithm. Therefore, many of the requested categories in your prompt are not applicable.

Here's the information that can be extracted from the provided text, adapted to the context of a control material's stability study:

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

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

The document does not specify a "sample size" in terms of individual units of control material tested for stability. It refers to "stress stability studies" and "Vigil TDM Controls Stability Study." The provenance of the data is Beckman Instruments, Inc., and the study appears to be retrospective as part of the premarket notification.

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

Not applicable. This is a stability study for a control material, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no expert review or adjudication process described for the stability study. Stability is determined by laboratory testing against established specifications.

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

Not applicable. This study is for a control material, not a diagnostic device, and does not involve human readers or AI assistance.

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

Not applicable. This study is for a control material, not an algorithm.

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

The "ground truth" for this study is the inherent stability of the control material, determined by quantitative analytical methods and comparison to pre-defined acceptance limits for analytes within the controls, measured over time and under stress conditions. The document states, "Stress stability studies of the Vigil TDM Controls support the Beckman stability claim of 24 months." This implies that the control material maintained its specified characteristics within acceptable limits after being subjected to the stress conditions.

8. The sample size for the training set

Not applicable. This is a stability study for a control material, not a machine learning model requiring a training set.

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

Not applicable. This is a stability study for a control material, not a machine learning model.

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