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Sebia Normal Control Serum is indicated for the quality control of densitometric quantification of electrophoretic separations of human serum proteins, lipoproteins and lipoprotein-cholesterol fractions on Sebia HYDRAGEL™ agarose gels. The Normal Control Serum is also indicated for the quality control of quantification of electrophoretic separations of human serum proteins on Sebia CAPILLARYS™, the capillary electrophoresis system.

The constituents of the Normal Control Serum are within the concentration ranges (g/dL) expected in normal individuals. The relative (%) distribution of individual fractions and the densitometric profile also reflect normal distribution.

Sebia Hypergamma Control Serum is indicated for the quality control of densitometric quantification of electrophoretic separations of human serum proteins on HYDRAGEL agarose gels and for the quality control of quantification of electrophoretic separations of human serum proteins on CAPILLARYS, the capillary electrophoresis system. The concentration of gammaglobulins in this control is elevated above the normal level.

The control values for all applicable tests for which the control materials are intended are determined for each lot of Control Serum. The control values are published in the product package insert included with each package of the Control Serum.

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The provided text is a 510(k) summary for a control serum device, specifically "Normal Control Serum" and "Hypergamma Control Serum." It is not a diagnostic device, and therefore the concepts of acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), ground truth, training/test sets, or expert reviews for clinical diagnosis are not applicable in the same way they would be for an AI-powered diagnostic tool.

This document describes the regulatory approval of quality control materials used to verify the performance of other diagnostic tests (electrophoretic separations). The "performance" of these control serums relates to their stability, consistency, and how well they reflect known values when run on specified platforms.

Therefore, I cannot extract the information requested in your prompt because the input document does not contain a study demonstrating the "device's performance" in a clinical diagnostic sense. Instead, it describes a control material and its intended use for quality control.

Here's why each point in your request cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not present specific performance metrics like sensitivity or specificity for the control serum. The "performance" here refers to its suitability as a quality control material. The acceptance criteria for these types of devices typically relate to their formulation, stability, and the range of expected values when used with target assays.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the sense of patient data for evaluating a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a control serum is its known chemical composition and the expected values it should yield on a properly functioning instrument. No clinical experts are involved in establishing this for a control material.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a control material is its chemically defined composition and the established reference values for its constituents, often determined by highly accurate reference methods or certified standards.
8. The sample size for the training set: Not applicable. There is no training set as it's not an AI model.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Name: Normal Control Serum, Hypergamma Control Serum
• Indications For Use: Quality control for densitometric quantification of electrophoretic separations of human serum proteins, lipoproteins, and lipoprotein-cholesterol fractions on specific Sebia systems (HYDRAGEL™ agarose gels and CAPILLARYS™ capillary electrophoresis system).
• Key "performance" aspect mentioned: "The control values for all applicable tests for which the control materials are intended are determined for each lot of Control Serum. The control values are published in the product package insert included with each package of the Control Serum." This describes the manufacturer's responsibility to characterize each lot of control material.

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