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For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems. Enhanced Estradiol (eE2) ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL. The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 hours.

The provided text is a 510(K) Summary for the ADVIA® Centaur Calibrator 30. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or information about sample sizes for test/training sets, expert involvement, or MRMC studies that you requested.

The document states: "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been validated following procedures of Siemens Healthcare Diagnostics." This indicates that internal validation was performed, but the specific performance metrics and acceptance criteria are not presented in this summary.

Therefore, I cannot fulfill your request for the specific sections as they are not present in the provided text.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: While the intended use and targeted concentration levels are mentioned, there are no explicit acceptance criteria or detailed performance data presented.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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, as this is a calibrator, not an AI-assisted diagnostic tool for human readers. This question is designed for AI/imaging devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a calibrator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a calibrator, "ground truth" would typically refer to the accurately assigned values of the analytes. The summary states "value assignment," but doesn't detail the method for establishing that "ground truth."
8. The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI algorithm, as this is a calibrator solution).
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information related to performance:

• Device: ADVIA Centaur Calibrator 30
• Intended Use: For in vitro diagnostic use in calibrating the Enhanced Estradiol (eE2) assays using ADVIA Centaur systems.
• Predicate Device: ADVIA Centaur Calibrator E (K932715/K954697)
• Performance Statement: "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been validated following procedures of Siemens Healthcare Diagnostics."
• Targeted Concentration of levels: Low = 35 pg/mL, High = 2500 pg/mL (for eE2).

The document's conclusion is that the ADVIA Centaur Calibrator 30 is substantially equivalent to its predicate. This substantial equivalence is based on similarities in intended use (though for a refined analyte), form, matrix, storage, and stability, despite differences in the specific analytes calibrated and their target concentrations. The "performance" section briefly states that validation was done, but does not provide the results of that validation in this public summary.

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