(14 days)
The Cardiac Troponin-I Calibrator (TROP CalPak) is intended to be used to calibrate the Cardiac Troponin I method on the Stratus® CS analyzer.
The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of troponin complex per well is 40 ng/mL. The CalPak is a single-use product.
This document is a 510(k) premarket notification for a medical device called the Stratus® CS Troponin I Calibrator (TROP CalPak). It is not a study report that includes acceptance criteria and performance data for a device in the way you've described for an AI/algorithm-based device.
The document primarily focuses on establishing "substantial equivalence" of a modified calibrator to a previously marketed calibrator. This regulatory process does not typically involve the kinds of performance studies, acceptance criteria, ground truth, or expert review that would be associated with a new diagnostic algorithm or device determining a medical outcome.
Therefore, I cannot extract the information you requested because it is not present in this document. Here's why and what kind of information is contained:
Why the requested information is not present:
- Nature of the Device: The device is a "calibrator," meaning it's a reference material used to ensure the accuracy of an analyzer (the Stratus® CS analyzer) that measures Cardiac Troponin I. It's not a diagnostic device that directly interprets patient data, makes a diagnosis, or an AI/algorithm.
- Regulatory Goal: The purpose of this 510(k) submission is to demonstrate that the modified calibrator is "substantially equivalent" to an already cleared calibrator. This relies on demonstrating that their intended use, operating principles, design, materials, etc., are similar enough that the new device is as safe and effective as the predicate. It does not require a de novo performance study against a ground truth as would be needed for a new diagnostic claim or an AI algorithm.
- "Acceptance Criteria" for a Calibrator: For a calibrator, "acceptance criteria" would typically relate to its manufacturing specifications, stability, and its ability to consistently produce expected values on the analyzer. These are internal manufacturing and quality control parameters, not performance metrics against a clinical ground truth.
What is available in the document:
- Predicate Device: Stratus® CS TROP CalPak (K981100)
- Differences from Predicate: The main difference is the "Analyte" source (Native human troponin complex vs. Troponin-I peptide fragment). Target Concentration also differs (40 ng/mL vs. 45 ng/mL).
- Conclusion: The modified calibrator is "substantially equivalent" based on the comparison provided.
In summary, this document is a regulatory submission for a laboratory calibrator, not a study evaluating an AI/algorithmic device's diagnostic performance. Therefore, it does not contain the information you asked for regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert review for diagnostic accuracy.
§ 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.