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

The Elecsys proBNP II CalCheck 5 is a lyophilized product consisting of NT-proBNP (1-76) amide, human serum and a potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

The provided submission discusses the Elecsys proBNP II CalCheck 5, a control product for immunoassay analyzers. As a control material and not a diagnostic device, the acceptance criteria and study detailed below focus on its performance as such.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the traditional sense of a patient cohort. For a control material, the "test set" would primarily involve multiple batches or samples of the control material tested across various instruments and conditions. The sample size for these evaluations (value assignment and stability studies) is not explicitly stated in the provided text.

The data provenance is also not explicitly stated beyond being part of a regulatory submission from Roche Diagnostics, indicating it would be internally generated data from their manufacturing and testing facilities. It would be considered prospective for the purposes of the submission, as the studies would have been conducted specifically to support the 510(k) application for the new product.

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

For a control material, the "ground truth" for its value is established through rigorous internal validation processes by the manufacturer, typically involving highly accurate reference methods and multiple expert analytical chemists or laboratory scientists. The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., the assigned values) for the Elecsys proBNP II CalCheck 5. This information is typically part of the internal quality control and manufacturing documentation, not necessarily detailed in a 510(k) summary for a Class I device.

4. Adjudication Method for the Test Set

Given the nature of a control material and the type of evaluation described ("value assignment and stability"), a formal "adjudication method" involving multiple human readers or reviewers of subjective data (like image interpretation) is not applicable. The "adjudication" in this context would be the internal quality control and statistical analysis methods used by Roche to determine the consensus assigned values and stability profiles, which are objective measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often in conjunction with AI. The Elecsys proBNP II CalCheck 5 is a laboratory control material, not an AI-powered diagnostic device, and its use does not involve human readers interpreting complex medical cases or images.

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

No, a standalone algorithm performance study was not done. The Elecsys proBNP II CalCheck 5 is a physical chemical control product, not a software algorithm or AI. Therefore, the concept of "algorithm only" performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys proBNP II CalCheck 5 refers to the assigned concentration values of NT-proBNP in each of the five levels. This ground truth is established through:

• Analytical measurement and calibration: Using highly accurate reference methods and calibrated instruments to determine the precise concentration of the analyte (NT-proBNP) spiked into the matrix during manufacturing.
• Manufacturer's internal validation: Rigorous testing and statistical analysis conducted by Roche Diagnostics to ensure the assigned values are accurate and reproducible.

It is not based on expert consensus of clinical images, pathology (histology), or patient outcomes data, as these are not relevant to the function of a laboratory control.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. The Elecsys proBNP II CalCheck 5 is a manufactured control material, not a machine learning algorithm that requires training data.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

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For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.

The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

This document describes the Elecsys proBNP II CalCheck, a quality control material intended for use in verifying the calibration of the Elecsys proBNP II reagent on specific immunoassay analyzers. As this is a quality control material and not a diagnostic device for patient diagnosis, the typical acceptance criteria and study designs for diagnostic accuracy (like sensitivity, specificity, accuracy against a gold standard in patient datasets) are not applicable in the same way.

Instead, the "performance" of such a device is evaluated by its ability to provide stable and accurate assigned values over time and under various conditions, ensuring it can properly verify the calibration of the main diagnostic assay.

Here's an analysis based on the provided text, addressing the requested information where applicable for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical "acceptance criteria" for the Elecsys proBNP II CalCheck in the format typically seen for diagnostic devices (e.g., sensitivity >X%, specificity >Y%). Instead, the performance is demonstrated through its intended function as a calibration verification material and its stability characteristics, compared to a predicate device.

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

The 510(k) summary does not provide specific details on the sample size (number of replicate measurements, number of lots, etc.) or data provenance (e.g., country of origin, retrospective/prospective) for the "value assignment and stability" evaluation of the Elecsys proBNP II CalCheck. Such details would typically be found in the full 510(k) submission and not in the summary. For a quality control material, the "test set" would generally refer to batches of the control material tested for analyte concentration, consistency, and stability over time and varying conditions.

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

Not applicable. For a quality control material used to verify calibration of an assay measuring a specific analyte (NT-proBNP), the "ground truth" is established through analytical methods and metrology, not by expert consensus or clinical interpretation. The assigned values for the control material are determined by precise laboratory measurements using reference methods or by comparison to primary standards.

4. Adjudication Method for the Test Set

Not applicable for a quality control material. Adjudication methods (like 2+1, 3+1) are used in studies where human readers are making subjective interpretations, typically with imaging or pathology. For analytical controls, the "truth" is determined by quantitative measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. MRMC studies are designed to assess the performance of diagnostic devices (especially those involving human interpretation, like imaging AI) by comparing the accuracy of multiple readers across multiple cases, often with and without AI assistance. The Elecsys proBNP II CalCheck is an analytical control material, not a diagnostic device that involves human interpretation or diagnosis.

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

Not applicable. This device is a biochemical control material, not an algorithm or AI system.

7. The Type of Ground Truth Used

For a quality control material like Elecsys proBNP II CalCheck, the "ground truth" for the assigned values is established through analytical laboratory measurements and metrological traceability. This means the concentration of NT-proBNP in each level of the control material is precisely quantified using validated analytical methods, often traceable to internationally recognized standards or highly characterized reference materials for NT-proBNP. It is a value assigned through rigorous scientific measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

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

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

Not applicable. As noted in point 8, there is no training set for this type of device.

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