(21 days)
The TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.
The Stratus® CS TROP CalPak is an in vitro diagnostic product used to calibrate the cardiac troponin I method on the Stratus® CS STAT fluorometric analyzer. The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL. The CalPak is a plastic cartridge which contains the calibrator material in reagent wells.
This document is a 510(k) premarket notification for the "Stratus® CS TROP CalPak" from Dade Behring. It is a calibrator for an in-vitro diagnostic product, and the information provided does not describe a clinical study of device performance in the way a medical AI/ML device would be evaluated. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or test results are provided in the document. This is because the device is a calibrator, not a diagnostic device with performance metrics like those for detecting diseases. Its "performance" would relate to its ability to accurately calibrate the Stratus® CS STAT fluorometric analyzer for cardiac troponin I measurements.
The document states:
- "The TROP CalPak is a buffered bovine protein matrix product with cardiac troponin I at an approximate concentration of 45 ng/mL."
- "The TROP CalPak is substantially equivalent to the Stratus® troponin I calibrator as they are both intended to be used as calibrators for similar cardiac troponin I methods."
The acceptance criteria for a calibrator would typically relate to its stability, homogeneity, and its ability to achieve intended calibration within the specified range for the analyzer. However, these details are not provided in this regulatory summary.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable to this type of device. There isn't a "test set" of patient data in the context of clinical AI/ML studies. The evaluation of a calibrator would likely involve internal testing by the manufacturer to ensure it performs its function correctly with the associated analyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a definitive diagnosis or measurement. For a calibrator, its "ground truth" is its precisely manufactured concentration of troponin I, which is established during its production and quality control.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, this type of study is not relevant for a diagnostic calibrator. MRMC studies are used to evaluate the impact of a diagnostic tool (often AI/ML) on human readers' performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The Stratus® CS TROP CalPak is a physical calibrator, not an algorithm.
7. The Type of Ground Truth Used:
For a calibrator, the "ground truth" would be the known, manufactured concentration of cardiac troponin I within the calibrator material (stated as "approximate concentration of 45 ng/mL"). This concentration is established by the manufacturer through rigorous analytical methods (e.g., gravimetric preparation, reference methods).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary Relevant to the Document's Purpose:
The core of this 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (the Stratus® troponin I calibrator). This means the manufacturer presented evidence that the TROP CalPak is as safe and effective as the predicate device for its intended use. The "study" mentioned here is an internal demonstration of equivalence and conformity to manufacturing standards, rather than a clinical trial with patient outcomes.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.