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The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Description

The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels 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.

AI/ML Overview

The provided text describes the Elecsys Progesterone III CalCheck 5, a control material, and studies conducted to demonstrate its stability. This is not a description of an AI/ML powered device, therefore some of the requested information (e.g. number of experts, adjudication methods, MRMC studies, standalone performance) is not applicable.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (for Stability Studies)	Reported Device Performance (as % Recovery or value)
Study 1: Open-Vial Stability
CalCheck Level 1: < 0.15 ng/mL	The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided)
CalCheck Level 2: 85-115% recovery of reference material value	The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided)
CalCheck Levels 3-5: 90-110% recovery of reference material value	The data support the package insert claim that reconstituted Progesterone III CalCheck 5 is stable up to 4 hours at 20-25°C. (Specific recovery values not provided)
Study 2: Accelerated Stability
CalCheck Level 1: ≤ 0.15 ng/mL	The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided)
CalCheck Level 2: 85-115% recovery of reference material value	The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided)
CalCheck Levels 3-5: 90-110% recovery of reference material value	The accelerated stability model employed supports an initial shelf-life claim of 18 months when stored at 2-8°C. (Specific recovery values not provided)

Note: The text explicitly states that specific recovery values for "on-test recovery" were calculated as a percent of the reference value, and that the data "support" or the model "supports" the claims. However, the precise numerical results for these recoveries are not provided in the summary.

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

Sample Size:
- Open-Vial Stability: One Elecsys Progesterone III CalCheck 5 lot was evaluated in duplicate.
- Accelerated Stability: One Elecsys Progesterone III CalCheck 5 lot was evaluated in duplicate.
Data Provenance: The studies were performed internally by Roche Diagnostics, presumably in Mannheim, Germany (registration number 9610126) or Penzberg, Germany (registration number 9610529), as these are the registered manufacturing sites. The data is prospective for these specific stability lots, as the studies are designed to test the stability of new product lots.

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 quality control material and not an AI/ML diagnostic or prognostic device requiring expert interpretation for ground truth establishment. The "ground truth" for these studies is the performance of the freshly reconstituted reference material.

4. Adjudication Method for the Test Set

This is not applicable. The studies involve quantitative measurements of progesterone levels, which do not require adjudication.

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

No, this is not applicable. This is a stability study for a quality control material, not a comparative effectiveness study involving human readers with or without AI assistance.

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

This is not applicable. The device is a control material, not an algorithm. The performance of the material is assessed using an immunoassay analyzer (cobas e 411).

7. The Type of Ground Truth Used

The ground truth for the stability studies is the performance of the freshly reconstituted reference material. This reference material is characterized against highly purified progesterone standards traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry), analogous to BCR-348R and ERM-DA347. This provides a highly accurate and traceable "true" value against which the stability of the test materials is compared.

8. The Sample Size for the Training Set

This is not applicable. The device is a control material and does not involve AI/ML requiring a training set.

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

This is not applicable. The device does not have a training set. However, the value assignment process for each CalCheck lot involves running the CalChecks in duplicate on at least three cobas e 601 analyzers, with the assigned value being the mean of at least 6 determinations. This process also involves comparisons to other analyzer platforms (cobas e 411) to ensure consistency. The underlying traceability is to ID-GC/MS.

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