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510(k) Data Aggregation
(184 days)
ELECSYS TROPONIN T CALCHECK 5
The Elecsys Troponin T 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 Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers.
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The provided document is a 510(k) clearance letter from the FDA for a quality control material, the Elecsys Troponin T CalCheck 5. This type of device does not involve studies with "device performance," "sample sizes for test sets," "experts for ground truth," "adjudication methods," or "MRMC comparative effectiveness studies" in the way these terms are typically used for diagnostic or AI-driven medical devices.
Instead, the "performance" of a quality control material refers to its ability to accurately verify the calibration and assay range of an in vitro diagnostic (IVD) test (in this case, the Elecsys Troponin T reagent on specific immunoassay analyzers).
Therefore, a direct answer to your request in the context of a diagnostic or AI device is not applicable for this document.
However, I can extract the relevant information about the acceptance criteria and how a device like this would meet them, based on the principles of regulatory clearance for IVD quality control products.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Typical for QC Material) |
|---|---|
| Intended Use Compatibility: The QC material must be compatible with the specified Elecsys Troponin T reagent and Elecsys/cobas e immunoassay analyzers for calibration verification and assay range verification. | The device's "Indications for Use" statement confirms its intended use with Elecsys Troponin T reagent on the indicated Elecsys and cobas e immunoassay analyzers. This explicitly defines the compatibility. |
| Traceability: The assigned values for the control material levels must be traceable to a recognized reference method or material. | Not explicitly stated in the provided document, but for such a device, the manufacturer would provide data demonstrating traceability of the assigned Troponin T values to an accepted reference standard (e.g., higher-order reference methods or materials). |
| Stability: The QC material must maintain its assigned values and integrity over its stated shelf-life and in-use period. | Not explicitly stated in the provided document, but the manufacturer's submission would include stability studies (real-time and accelerated) demonstrating that the material remains within acceptable limits for its claimed shelf-life and after reconstitution/opening. |
| Homogeneity: Different aliquots of the control material must yield consistent results. | Not explicitly stated in the provided document, but manufacturing data would show consistent composition across production lots. |
| Value Assignment: The assigned values for each control level must be established accurately and precisely through a robust value assignment protocol. | Not explicitly stated in the provided document, but the manufacturer's submission would detail the process and data for assigning the target values and their acceptable ranges for each level of the CalCheck 5. This would involve multiple measurements on multiple instruments using reference methods. |
Regarding the Study for Acceptance Criteria:
The "study" for a quality control material like Elecsys Troponin T CalCheck 5 is typically a verification and validation (V&V) program conducted by the manufacturer. This program encompasses various tests and analyses rather than a single clinical trial with patient data or expert reads.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the sense of patient samples. For a QC material, the "test set" would be the number of vials/lots of the QC material tested and the number of measurements taken to establish its characteristics (e.g., homogeneity, stability, value assignment). This is typically determined by statistical sampling plans to ensure representativeness and sufficient power for the specific tests. The provenance would be the manufacturer's internal laboratories.
- Data Provenance: The data would originate from prospective internal laboratory studies conducted by Roche Diagnostics during the product development and manufacturing process. This would typically be conducted at their facilities in a controlled environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. For a quality control material, "ground truth" for its characteristics (assigned values, stability) is established through rigorous analytical testing and metrological traceability using established reference methods and calibrated instruments, not by expert interpretation of clinical data. The experts involved would be analytical chemists, biochemists, and statisticians with expertise in IVD manufacturing and assay development, rather than clinical experts like radiologists.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication (e.g., 2+1, 3+1 for clinical consensus) is used to resolve discrepancies in expert interpretation of clinical data. For a QC material, objective analytical measurements are the primary data source. Statistical methods are used to analyze the results and determine if they meet pre-defined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is relevant for evaluating the impact of a diagnostic device (especially imaging or AI-driven) on human reader performance. Elecsys Troponin T CalCheck 5 is a quality control material, not a diagnostic device that humans interpret.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This concept is specific to AI or algorithmic diagnostic devices. A quality control material like CalCheck 5 does not involve an algorithm with "standalone performance" in this context. Its function is to verify the performance of an analyzer/reagent system.
7. Type of Ground Truth Used:
- The "ground truth" for a quality control material is its analytically determined and metrologically traceable assigned value for each analyte (Troponin T in this case) at each control level. This value is established through a comprehensive process involving:
- Reference Methods: Often comparing results to a higher-order reference measurement procedure (e.g., isotope dilution mass spectrometry, if available and appropriate).
- Consensus Studies: Using multiple instruments and laboratories to generate a robust mean value.
- Certified Reference Materials (CRMs): Ensuring traceability to international or national standards.
8. Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML model.
In summary, the provided document pertains to regulatory clearance for a quality control material. The acceptance criteria and "studies" for such a device are fundamentally different from those for diagnostic or AI-powered medical devices. The focus is on analytical performance, stability, homogeneity, and traceability of the control material itself, rather than clinical performance based on patient data or expert interpretation.
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