(57 days)
The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin I method on the Stratus® CS 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 cTnI CalPak is a plastic cartridge, which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concertration to troponin complex per well is 40 ng/mL. The CalPak is a single-use product.
The provided document is a 510(k) summary for the Dade Behring Stratus® CS Troponin I Calibrator (cTnI CalPak). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new clinical diagnostic device. Therefore, much of the requested information, such as sample sizes, expert involvement, and ground truth methodologies related to a formal performance study, is not present in this document.
However, I can extract the acceptance criteria for equivalency and describe the comparison made.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on "substantial equivalence" to a predicate device. The performance is assessed by comparing key attributes of the new device to the predicate.
| Item | Acceptance Criteria (Predicate Device: Stratus® CS TROP CalPak K983722) | Reported Device Performance (Stratus® CS cTnI Cal Pak - modified) | Meets Acceptance Criteria? |
|---|---|---|---|
| Intended Use | Calibrator | Calibrator | Yes |
| Analyte | Native human troponin complex | Native human troponin complex | Yes |
| Matrix | Buffered bovine protein | Normal human serum (modified from predicate) | N/A (difference noted) |
| Form | Frozen | Frozen | Yes |
| Target Concentration | 40 ng/mL | 40 ng/mL | Yes |
| Values | Assigned | Assigned | Yes |
| Packaging Configuration Values | Single use plastic cartridge | Single use plastic cartridge | Yes |
| Levels | One | One | Yes |
Note on Acceptance Criteria: In this context, "acceptance criteria" revolve around demonstrating that the modified device is substantially equivalent to the predicate device, implying that any differences do not raise new questions of safety or effectiveness. The change in matrix from buffered bovine protein to normal human serum is noted as the primary modification, but the conclusion is still substantial equivalence.
Regarding other requested information, it is not available in this document:
- Sample size used for the test set and the data provenance: Not applicable as this is a comparison for substantial equivalence, not a performance study with a test set of patient samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a calibrator, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a calibrator, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the calibrator would be its assigned value and consistency, which is implicitly accepted by demonstrating equivalence to the predicate calibrator.
- The sample size for the training set: Not applicable. This calibrator does not involve a training set as it's not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 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.