Search Results

Progesterone III CalSet is used for calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Progesterone III CalSet is a lyophilized product consisting of plant-derived progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography/mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.

Here's a breakdown of the acceptance criteria and the study details for the Elecsys Progesterone III CalSet, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes three stability studies with a consistent acceptance criterion.

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

• CalSet Value Assignment: Tested on "at least three (3) cobas e 411 analyzers and at least three (3) cobas e 601/MODULAR ANALYTICS E170 analyzers with all Progesterone III reagent lots available." The assigned value is the median of at least six runs of the respective calibrator. The testing also involved PreciControl Universal levels 1 & 2.
• Stability Studies (Reconstitution, Accelerated, Real-Time): Specific sample sizes for each test condition (e.g., number of vials, number of runs per vial) are not explicitly stated as a single number. However, for recombinant stability and accelerated stability, it mentions "on-test materials" and "one Progesterone III CalSet lot was evaluated in duplicate" for accelerated stability. The real-time study is ongoing with "Progesterone III CalSet test material" tested in duplicate.
• Data Provenance: The studies were conducted at Roche Diagnostics GmbH in Mannheim, Germany, and Penzberg, Germany, and Roche Diagnostics United States. The data appears to be prospective as it's part of the premarket notification for a new device.

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

This device is a calibrator for an immunoassay. The concept of "experts establishing ground truth" in the diagnostic imaging/CAD sense does not directly apply here. Instead, the ground truth for the analyte concentration in the calibrator is established through traceability to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347 using ID-GC/MS (isotope dilution gas chromatography/mass spectrometry). This is a metrological approach to establishing a reference value, rather than expert interpretation of a clinical finding.

4. Adjudication Method for the Test Set

Not applicable in the context of a calibrator's analytical performance.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is designed for diagnostic tools that assist human readers (e.g., CAD systems for mammography), whereas the Elecsys Progesterone III CalSet is a calibrator for an automated immunoassay system.

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

Yes, the performance studies described (value assignment and stability) are standalone evaluations of the calibrator's analytical characteristics. The calibrator itself is a component used by an automated immunoassay system (Elecsys and cobas e immunoassay analyzers) and does not involve human interpretation in its direct function.

7. The Type of Ground Truth Used

The ground truth for the Elecsys Progesterone III CalSet is established through traceability via ID-GC/MS (isotope dilution gas chromatography/mass spectrometry) to highly purified progesterone by weight analogous to certified reference materials (BCR-348R and ERM-DA347). This provides a highly accurate, metrologically sound reference for the concentration of progesterone in the calibrator.

8. The Sample Size for the Training Set

The concept of a "training set" is not directly applicable in the documentation for this calibrator. Calibrators are manufactured to specific specifications and then undergo verification and validation testing, not a machine learning training process. The value assignment process involves running calibrators on multiple instruments and reagent lots to determine assigned values, which is more akin to a robust validation process than machine learning training.

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

As noted above, a "training set" in the machine learning sense is not used. The reference values (ground truth) for the calibrator were established through the metrological traceability mentioned in point 7.

Ask a specific question about this device