(10 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text for diagnostic performance. The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device in terms of intended use. The device's performance would be its ability to provide accurate values for calibration verification when reconstituted and assayed in triplicate, as compared to its target values. | Intended use is the same as the predicate device: "To verify the calibration curve of automated immunoassay analyzers." The device 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." This implies that its values, when measured, should be consistent with its target values. |
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.