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The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.

The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, Level 1 is buffer with bovine serum albumin and preservatives. Levels 2-6 are various levels of USP-Grade estradiol in Ivophilized normal male serum with sodium azide (0.1% after reconstitution) and preservatives.

The eE2 Master Curve Materials have expected values (lot specific) of 0, 60, 175, 450, 1500 and 2700 pg/mL.

The eE2 Master Curve Material (1.0 mL/vial) are Ivophilized material and stored at 2 -8°C.

This is a 510(k) summary for a calibration verification material, not a medical device in the typical sense of diagnosing or treating a disease. Therefore, many of the typical acceptance criteria and study elements listed in your request (like "human readers improve with AI vs without AI assistance," "standalone performance," "number of experts," etc.) are not applicable here.

The "device" in this context is the ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, which is a quality control material used to verify the calibration and reportable range of a diagnostic assay (the ADVIA Centaur® Enhanced Estradiol (eE2) assay).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a calibration verification material, the "acceptance criteria" and "performance" are primarily related to its ability to accurately verify the assay's calibration and range. The document states:

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

• Test Set Sample Size: The document does not specify a sample size for a 'test set' in the context of typical clinical performance studies. The evaluation is focused on the characteristics of the material itself (traceability, value assignment, stability) and its equivalence to a predicate device.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The studies performed were internal validation studies by Siemens Healthcare Diagnostics. The material itself contains human source material (normal male serum), but this refers to the composition of the material, not the provenance of clinical data.

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

• Not Applicable. This type of device does not involve expert interpretation of images or clinical data to establish ground truth. The "ground truth" for this device relates to the assigned values of estradiol, which are established through a rigorous calibration and validation process by the manufacturer, typically traceable to reference methods or materials, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication method in the traditional sense, as there are no clinical cases or disagreements among interpreters to resolve.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not relevant for a calibration verification material. This device does not involve human readers interpreting clinical cases with or without AI assistance.

6. Standalone Performance Study

• Yes, implicitly. The document describes the "Performance" of the device in terms of its traceability, value assignment, and stability, all of which are assessed independently of human interpretation of clinical data. This is the standalone performance of the material. However, it's not "algorithm-only" performance as there is no algorithm or AI involved. It's the performance of the chemical reference material itself.

7. Type of Ground Truth Used

• Assigned Values / Reference Method Traceability. The "ground truth" for this device is the assigned estradiol concentrations for each of the six levels (0, 60, 175, 450, 1500, 2700 pg/mL). These values are established through the manufacturer's value assignment procedures, which typically involve measuring against a higher-order reference method or certified reference material to ensure traceability and accuracy.

8. Sample Size for the Training Set

• Not Applicable / Not provided. This is not a machine learning or AI algorithm, so there is no "training set." The material's formulation and assigned values are determined through chemical and analytical validation, not statistical learning from a dataset.

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

• Not Applicable. There is no training set for this type of device. The ground truth (assigned values for estradiol) for the material itself is established through the manufacturer's validated procedures, likely involving extensive analytical testing and comparison to reference standards.

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