(15 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance (Stability) |
|---|---|
| Device stability must support a 24-month shelf life. | Stress stability studies at various temperatures (25°C, 32°C, 37°C, 41°C) demonstrate stability over various durations, supporting the 24-month stability claim. |
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.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.