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The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Cyclosporine (CsA) assay.

The ADVIA Centaur® Cyclosporine Master Curve Material are 5 level human serum based solutions containing varying concentrations of cyclosporine in human serum, bused offerents, glycerol, anti-foam and preservatives. The Cyclosporine Master Curve deterials have expected values (lot specific) of 0, 100, 500, 900 and 1400 ng/mL.

The Cyclosporine Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.

CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDA-Scrum or plashia censi frind nonreactive for hepatitis B surface antigen (HBsAg), antibody to approvou mothous and rotibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer matchan once that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ADVIA Centaur® Cyclosporine Master Curve Material.

It's important to note that this document is a 510(k) summary for a medical device (a control material for an immunoassay), not an AI/ML powered diagnostic device. Therefore, many of the requested fields (such as MRMC studies, number of experts for ground truth, sample size for training set, etc.) are not applicable in this context. The "performance" section primarily focuses on technical validation of the control material itself, rather than diagnostic accuracy against a disease state.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the ADVIA Centaur® Cyclosporine Master Curve Material does not explicitly provide a table of acceptance criteria in the traditional sense of a diagnostic device (e.g., target sensitivity, specificity). Instead, it describes the validation of the material's properties, which effectively serve as the performance characteristics for this type of device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set sample size" in the conventional diagnostic sense (i.e., a number of patient cases tested). The validation described pertains to the control material itself.

• Test Set: Not applicable as a patient-based test set. The material itself is the subject of testing for its properties.
• Data Provenance: The document implies internal validation by Siemens Healthcare Diagnostics. No country of origin for specific "data" is mentioned, nor is it specified if the validation was retrospective or prospective. It would be prospective in nature for a new manufacturing lot.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a control material, "ground truth" is established by manufacturing and analytical processes (e.g., gravimetric preparation, reference methods, stability studies), not by expert medical interpretation of cases.

4. Adjudication Method for the Test Set

Not applicable, as there's no diagnostic test set requiring 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 control material for an in vitro diagnostic assay, not an AI/ML powered diagnostic device. No human readers or AI assistance are involved in its performance or evaluation as described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a biochemical control material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the ADVIA Centaur® Cyclosporine Master Curve Material is established through analytical reference methods and manufacturing specifications. Specifically:

• Manufacturing Specifications: The materials are prepared to contain "varying concentrations of cyclosporine" with "expected values (lot specific) of 0, 100, 500, 900 and 1400 ng/mL." This implies the "true" concentration levels are known based on the meticulous preparation process.
• Traceability and Value Assignment: These processes (as stated: "validated following procedures of Siemens Master Curve Materials") would involve established methods and possibly certified reference materials to assign the target values accurately.
• Stability Studies: These establish the ground truth regarding how long the material maintains its assigned values under different storage conditions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML product.

Summary of the Study Proving Device Meets Acceptance Criteria

The study described is an internal validation process conducted by Siemens Healthcare Diagnostics for their ADVIA Centaur® Cyclosporine Master Curve Material. The performance section states:

"The traceability, value assignment, and stability of the ADVIA Centaur® Cyclosporine Master Curve Materials have been validated following procedures of Siemens Master Curve Materials."

This indicates that Siemens Healthineers has established internal protocols and procedures for ensuring the quality, accuracy, and shelf-life of their control materials. These procedures would involve:

• Manufacturing Control: Precise formulation of the control material to achieve the stated cyclosporine concentrations (0, 100, 500, 900, and 1400 ng/mL).
• Analytical Verification: Using established analytical methods (likely on the ADVIA Centaur Cyclosporine assay itself, and potentially against external reference methods) to confirm the assigned values for each lot.
• Stability Studies: Protocols simulating long-term storage (unopened), short-term storage (opened), and on-board usage conditions to determine how long the material maintains its integrity and assigned values within acceptable limits. This would involve repeat testing over time intervals.
• Biohazard Testing: Screening of all human source material used in the controls for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.

The conclusion drawn from these internal validations is that the device is "substantially equivalent to other products in commercial use of a similar use" and "substantially equivalent to the predicate device," meaning it performs comparably and safely for its intended purpose as a calibration and reportable range verification material.

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