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The Boehringer Mannheim Elecsys® CalCheck™ Troponin T is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Troponin T assay.

Elecsys CalCheck Troponin T calibration verification solutions comprise three levels - low, mid. and high - each with a defined Troponin T concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.

The Elecsys CalCheck Troponin T is intended for use in periodic verification of the calibration of the Elecsys Troponin T assay.

The Boehringer Mannheim Elecsys CalCheck Troponin T is manufactured using bovine serum albumin, human recombinant Troponin T, stabilizers, and preservatives. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.

The provided text describes the 510(k) summary for the "Elecsys CalCheck Troponin T" device. This device is a calibration verification material, not a diagnostic device that measures patient samples. Therefore, the acceptance criteria and study details are focused on the performance of the calibration material itself (value assignment and stability), rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for devices that provide patient results.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document is a 510(k) summary which focuses on demonstrating substantial equivalence to a predicate device. It states that the device "was evaluated for value assignment and stability." However, it does not explicitly list quantitative acceptance criteria for these evaluations or the specific results obtained. This level of detail is often found in the full 510(k) submission, not typically in the publicly available summary. For a calibration verification material, typical acceptance criteria would involve:

• Value Assignment: The measured values for each level (low, mid, high) must fall within a predefined range of the assigned target values. This range is usually determined by precision goals and clinical requirements for the assay being calibrated.
• Stability: The assigned values must remain within predefined acceptable limits over a specified period (e.g., shelf-life, open-vial stability) under various storage conditions (e.g., refrigerated, room temperature). Changes within these limits are usually compared to initial assigned values.

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

The document does not specify a "test set" in the context of diagnostic performance on patient data. For a calibration verification material, the "test set" would refer to the lots or units of the Elecsys CalCheck Troponin T that were manufactured and evaluated.

• Sample size: Not specified. The summary states that the material "was evaluated for value assignment and stability," implying that a sufficient number of product lots or units were tested, but no concrete numbers are given.
• Data Provenance: Not applicable in the traditional sense of patient data. The evaluations would have been conducted internally by Boehringer Mannheim Corporation, likely in their manufacturing and R&D facilities. The country of origin for the data is therefore the USA, where Boehringer Mannheim Corporation is listed. The study would be prospective in the sense of manufacturing and testing new lots of the CalCheck material.

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

This concept is not applicable for a calibration verification material. "Ground truth" for this type of device relates to the accurately assigned concentrations of Troponin T within the calibration solutions.

• Establishing Ground Truth: The "ground truth" (i.e., the target concentration values for each level – low, mid, high) would be established through highly controlled analytical methods and reference materials, often involving a hierarchical traceability chain to international standards. This process typically involves:
  • Using reference measurement procedures (RMPs) or highly accurate, validated methods.
  • Comparing against certified reference materials (CRMs).
  • Multiple measurements by skilled analytical chemists or laboratory professionals.
• The document does not detail the specific number or qualifications of individuals involved in the value assignment process, as it is a standard laboratory procedure for reference material production.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of diagnostic images or data in clinical studies. For a calibration material, discrepancies in value assignment would be resolved through re-analysis, investigation of analytical errors, or use of a reference method.

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

No, an MRMC study was not done. MRMC studies are used to evaluate the impact of a diagnostic device (especially imaging AI) on human reader performance. The Elecsys CalCheck Troponin T is a calibration material, not a diagnostic device.

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

Yes, in a sense. The "performance characteristics" evaluated (value assignment and stability) represent the standalone performance of the calibration material itself, independent of human interpretation of a diagnostic result. The device's output (its assigned value) is assessed directly through analytical methods.

7. The Type of Ground Truth Used

The ground truth used for this calibration verification material would be assigned values derived from:

• Reference materials: Highly pure human recombinant Troponin T.
• Analytical methods: Precisely measured concentrations using validated laboratory techniques, traceable to higher-order reference measurement procedures or international standards where available.
• Formulation specifications: The material is manufactured by "appropriately spiking" the analyte to achieve specific concentrations.

It is not based on expert consensus, pathology, or outcomes data, as those relate to diagnostic findings in patients.

8. The Sample Size for the Training Set

Not applicable. The Elecsys CalCheck Troponin T is a chemical reagent product, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development.

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

Not applicable, as there is no training set for this device.

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Elecsys CalCheck Troponin T is intended for use in the quantitative verification of the calibration curve established by the Elecsys Troponin T reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

The Elecsys CalCheck Troponin T is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

The provided text describes a 510(k) summary for a calibration verification material called "Elecsys CalCheck Troponin T." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a diagnostic device.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily about the device's intended use and its comparison to a similar, already approved device for regulatory purposes.

Here's an attempt to answer the questions based on the available information, noting when information is not present:

Introduction

The Elecsys CalCheck Troponin T is a calibration verification material, not a diagnostic device that measures a specific physiological state. Its performance is evaluated by its ability to reliably verify the calibration curve of an immunoassay analyzer. The study presented is a comparison to a predicate device to establish substantial equivalence for regulatory approval (510(k)), not a study to prove meeting predefined acceptance criteria for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a calibration verification material and the submission focuses on substantial equivalence, there are no explicit "acceptance criteria" for diagnostic performance in the traditional sense (e.g., sensitivity, specificity, accuracy against a gold standard) presented in this 510(k) summary. The "performance" is implicitly its ability to function as intended for calibration verification, which is demonstrated by its similarity to the predicate device.

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

• Sample Size for Test Set: Not specified in the provided text. The description mentions that the material is "assayed in triplicate," which refers to the procedure for using the material, not a sample size for an independent performance study of the material itself.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not applicable. As a calibration verification material, the "ground truth" would be the assigned target values for the material itself, established through manufacturing and assaying processes, not by expert consensus on patient data.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a test set requiring adjudication from a clinical perspective.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging or similar applications where multiple readers interpret clinical cases. This device is a calibration verification material.

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

• Not applicable. This is a physical calibration material, not an algorithm. Its function is to verify an analyzer's calibration, which is a standalone function in a laboratory assay context.

7. The Type of Ground Truth Used

• The ground truth for this type of device would be the assigned target values for each of the three levels of the calibration verification material. These values are established during the manufacturing and characterization of the product. The text states: "...the results are compared to the target values."

8. The Sample Size for the Training Set

• Not applicable. This is a calibration verification material, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set is involved.

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