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The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method is used for in vitro quantitation of albumin in urine).

The ADVIA® Chemistry Microalbumin 2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin 2 method (this method is used for in vitro quantitation of albumin in urine).

The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin 2 Calibrators are each 5 level liguid aqueous buffered solutions containing varying concentrations of purified human serum albumin. The Microalbumin Calibrators have expected values (lot specific) of 1, 2.5, 5, 10, and 20 mg/dL, and the Microalbumin 2 Calibrators have expected values (lot specific) of 1, 4, 10, 20, and 40 mg/dlL.

The calibrators (2 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.

This submission describes a calibration device, not an AI/ML powered diagnostic device. As such, the information typically requested for AI/ML device evaluations (e.g., sample sizes for test and training sets, ground truth establishment, MRMC studies, standalone performance) is not applicable or provided in this document.

However, I can extract the acceptance criteria as presented in the comparative table, which focuses on device characteristics and performance related to its function as a calibrator, and then summarize the study's conclusions regarding these criteria.

Here's the closest interpretation of your request based on the provided text, focusing on the "acceptance criteria" through comparison to a predicate device:

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance

For this type of device (calibrators), "acceptance criteria" are implicitly met if the new device demonstrates substantial equivalence to a legally marketed predicate device across key performance characteristics. The table below outlines these characteristics and how the new devices compare to the predicate, demonstrating their "performance" relative to these criteria.

Study Proving Device Meets Acceptance Criteria:

The study involved demonstrating "traceability, value assignment, and stability" of the ADVIA® Chemistry Microalbumin and ADVIA® Chemistry Microalbumin_2 Calibrators. These validations followed "procedures of Siemens Medical Solutions Diagnostics." The conclusion drawn from this internal validation and comparative analysis is that:

"The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin_2 Calibrators are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed DCL Microalbumin Multi-Calibrator Set (K042243) in intended use, matrix, expected values, and stability."

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

• Sample Size: Not explicitly mentioned in terms of a "test set" as for a diagnostic device. The "performance" assessment is based on the characteristics of the calibrators themselves (e.g., stability over time, value assignment) rather than clinical samples.
• Data Provenance: The study was conducted internally by Siemens Medical Solutions Diagnostics. Information regarding country of origin or whether it was retrospective/prospective is not provided, but given it's a calibrator, it would involve laboratory-based testing rather than patient data.

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

This is not applicable as the device is a calibrator, not a diagnostic device that requires expert ground truth for interpretation of results. The "ground truth" for a calibrator relates to its assigned values and stability, which are determined through metrological principles and internal validation processes, likely by qualified scientists or chemists within Siemens.

4. Adjudication Method for the Test Set:

Not applicable for a calibrator device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, typically from medical images, and an AI assists in that interpretation. This device is a calibrator, which is a reagent used to standardize other assays.

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

Not applicable. This is not an algorithm-based device. Its performance is inherent to its chemical properties and manufacturing consistency.

7. The Type of Ground Truth Used:

The "ground truth" for a calibrator refers to its assigned concentration values and its consistent performance over time (stability). This is likely established through:

• Reference Methods/Materials: Traceability to established reference methods or certified reference materials for human serum albumin.
• Analytical Validation: Rigorous analytical testing to confirm the stated concentrations and assess the stability of the calibrator solutions under various conditions.

8. The Sample Size for the Training Set:

Not applicable. This device is a calibrator, not an AI/ML model that requires a training set.

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

Not applicable as there is no training set for this type of device.

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