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Vigil Lipid Control stabilized liquid-control serums are intended for monitoring the reliability of manual and automated in vitro diagnostic assays of lipid analytes. The values for this control have been established using Beckman Coulter Reagents on Beckman Coulter Clinical Analyzers, and are specific for those systems. The use of three or more levels of control enables the laboratorian to monitor changes 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 Coulter, Inc. Each kit contains 4 X 4 mL bottles of a single level of control. Vigil Lipid Controls are made from stabilized human serum and are designed to monitor the reliability of manual and automated in vitro diagnostic assays of lipid analytes in the clinical laboratory. Vigil Lipid Control serum is derived from human plasma that has been defibrinated and then stabilized by freezing at temperature between -15°C and -20°C.

The provided document, a 510(k) summary for the "Vigil™ Lipid Control," primarily focuses on regulatory approval and substantial equivalence to a predicate device. It lacks detailed information about specific acceptance criteria, study methodologies, and performance data typically found in a comprehensive clinical or performance study report. Therefore, I cannot fully answer all aspects of your request based on the provided text.

Here is an analysis of what information can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states: "Performance data from validation testing supports equivalency." However, it does not provide a table of specific acceptance criteria (e.g., precision limits, accuracy targets) nor the reported device performance values against those criteria.

Missing Information:

The document does not contain the following information:

• Sample size used for the test set and the data provenance: There is no mention of a specific test set, its size, or the country of origin of the data, nor is it stated whether the data was retrospective or prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or their qualifications for establishing ground truth.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Since no test set or expert ground truth establishment is described, no adjudication method is detailed.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This type of study is not mentioned as this is a quality control material, not typically an imaging or diagnostic device requiring MRMC studies.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a quality control material, not an algorithm.
• The type of ground truth used: There is no explicit mention of ground truth as the document focuses on the control's performance with specific analyzers and reagents. For a quality control material, "ground truth" would typically refer to the accurately assigned values for the analytes within the control, established through a robust reference method or certified reference materials. The document states, "The values for this control have been established using Beckman Coulter Reagents on Beckman Coulter Clinical Analyzers, and are specific for those systems," implying that the "truth" for the control's performance is tied to its expected behavior on the specified systems.
• The sample size for the training set: This is not applicable as the device is a quality control material, not an AI/algorithm-based device that requires a training set.
• How the ground truth for the training set was established: This is not applicable.

Explanation for Missing Information:

The "Vigil™ Lipid Control" is a quality control material for in vitro diagnostic assays. Its regulatory submission (510(k)) primarily focuses on demonstrating that it is "substantially equivalent" to a legally marketed predicate device, especially after modifications (rewording of intended use, adding value assignments for new assays). For this type of device, the "study that proves the device meets the acceptance criteria" would typically involve:

1. Value Assignment Studies: Establishing the target ranges for various lipid analytes within the control material when run on specific Beckman Coulter analyzers with specific reagents.
2. Stability Studies: Demonstrating that the control material maintains its assigned values and integrity over its shelf life and during use.
3. Homogeneity Studies: Ensuring that the control material is uniform throughout the batch.
4. Performance on Target Systems: Running the control on the intended analyzers to verify it performs within acceptable ranges (precision, bias) and can detect significant shifts in assay performance.

The provided 510(k) summary states "Performance data from validation testing supports equivalency," meaning these types of tests were likely performed to demonstrate that the modified Vigil Lipid Control performs similarly to the predicate Vigil Lipid Control and can fulfill its intended purpose of monitoring assay reliability. However, the details of these tests (specific acceptance criteria, results, sample sizes, etc.) are not included in this high-level summary. They would typically be found in the full 510(k) submission not publicly disclosed in this format.

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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

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.

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