(68 days)
The proposed device is limited to modifications in the indications for use. The additional indication for use is to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay and Stratus® Cardiac Troponin-I Calibrators
This 510(k) summary is for a device modification, not a submission for a new device. Therefore, it focuses on demonstrating substantial equivalence to a previously cleared device (K951890) and specifically addresses an additional indication for use rather than presenting a de novo study proving the device's fundamental performance against acceptance criteria for a new device.
As such, the information requested in your prompt regarding acceptance criteria, study design for ground truth establishment, sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies is not present in this document. This summary is not a detailed clinical study report but a regulatory filing appendix.
However, I can extract what is available about the extended indication:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This document is about substantial equivalence for a modified indication, not the establishment of new acceptance criteria for the core assay performance. The "new" performance is the ability to aid in risk stratification, which is implied to be met by demonstrating substantial equivalence to a device already cleared for Troponin-I measurement and, presumably, by internal studies validating this specific risk stratification utility (though not detailed here).
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new clinical test set is described for this submission. The "additional indication for use is to aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality" implies that earlier clinical data or ongoing research (not detailed here) supported this claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is an in vitro diagnostic (IVD) device, not an imaging or diagnostic device requiring human reader interpretation in the same way. The output is a quantitative measurement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the typical sense. IVD devices inherently operate "standalone" in generating a quantitative result; the human "in the loop" is the physician interpreting the result. The performance of the assay itself is what is being cleared, not an algorithm's classification without human intervention.
7. The Type of Ground Truth Used
Not explicitly stated in this summary. For the additional indication (risk stratification of mortality), the ground truth would typically be actual patient mortality outcomes observed over a defined follow-up period.
8. The Sample Size for the Training Set
Not applicable. No training set for a new algorithm or model is described in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.