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The Elecsys Prolactin II 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 Prolactin II reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys Prolactin II CalCheck 5 is a lyophilized product consisting of prolactin in an equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes the Elecsys Prolactin II CalCheck 5, an assayed control for calibration verification and assay range verification. It is a control material, not an AI/ML powered device, therapeutic device, or diagnostic device that directly analyzes patient data for clinical decisions. Therefore, much of the requested information (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from the provided text for this type of device.

However, I can extract information related to its "performance" as a control material:

1. Table of acceptance criteria and the reported device performance:

The document mentions "Performance The Elecsys Prolactin II CalCheck 5 was evaluated for value assignment and Characteristics stability." However, it does not explicitly state specific numerical acceptance criteria or detailed reported performance figures for these evaluations. It only states what was evaluated.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable. The "device" is a control material, not a diagnostic or AI device that uses a test set of patient samples in the traditional sense. The evaluations would involve testing the control material itself in laboratory settings. The document does not specify sample sizes for these internal evaluations or data provenance regarding origin or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. As a control material, "ground truth" is typically established by certified reference methods or established assays in a laboratory setting, not by human experts interpreting clinical data. The document does not provide details on how the "value assignment" was established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the primary function of a control material's performance evaluation.

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. This device is a control material, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is not an algorithm or AI-powered device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for "value assignment." For control materials, this typically refers to the assigned concentration of the analyte (Prolactin II in this case). This assignment is usually performed by manufacturers using highly accurate assays or reference methods, but the specific methodology is not detailed in this summary.

8. The sample size for the training set:

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

9. How the ground truth for the training set was established:

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

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