(22 days)
Beckman's Vigil Lipid Control is intended for use in monitoring the reliability of automated in vitro diagnostic assays of total cholesterol, HDL cholesterol (HDLc), triglycerides, apolipoprotein A-1 and apolipoprotein B in the clinical laboratory. The use of three or more levels of control allows the laboratorian to monitor change in calibration linearity along with analytical error and imprecision.
The VIGIL™ Lipid Controls are four level ready-to-use human serum-based liquid controls manufactured by Beckman Instruments, Inc. Each kit contains 4 X 4 mL bottles of a single level of control.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device) | Reported Device Performance (VIGIL™ Lipid Control) |
|---|---|
| Same intended use as predicate | Same intended use as predicate |
| Same value assignment process as predicate | Same value assignment process as predicate |
| Same storage temperature as predicate (-15 °C to -20°C) | Same formulation and storage at -15 °C to -20°C (Stress stability studies support 24 months, which is implied as being acceptable and comparable to the predicate). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a "test set" in the traditional sense of evaluating diagnostic accuracy. Instead, the performance data provided is limited to stress stability studies.
- Sample size: Not explicitly stated as a number of control samples. The studies involve measuring stability at various temperatures for different durations.
- Data Provenance: Not specified, but likely internal Beckman Instruments testing given the context of a 510(k) submission. Retrospective or prospective is not explicitly mentioned, but stability studies are typically prospective, designed to evaluate product degradation over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a quality control material, not a diagnostic device that interprets clinical data or images. The "ground truth" for a quality control material is its assigned value(s) for the analytes it contains, which is established through a value assignment process. The document states this process is "Same as the predicate." Further details on how these values are established (e.g., use of reference methods, certified reference materials) are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a quality control material, not a diagnostic device requiring interpretive adjudication.
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 device is a quality control material 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 is a quality control material for laboratory assays, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the VIGIL™ Lipid Controls refers to the assigned values of the individual analytes (total cholesterol, HDL cholesterol, triglycerides, apolipoprotein A-1, and apolipoprotein B) contained within the control material. The document explicitly states that the "Value Assignment" process is "Same as the predicate." While the specifics of this process are not detailed, for quality control materials, this typically involves:
- Target Values: Established through analysis on highly accurate and precise reference methods or instruments, often linked to international reference materials.
- Interlaboratory Consensus: Participation in interlaboratory proficiency testing programs where target values are determined by consensus of multiple expert laboratories using reference methods.
8. The sample size for the training set
The document does not refer to a "training set" in the context of machine learning. The studies described are performance studies for a quality control material, specifically shelf-life stability.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the machine learning sense for this device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.