(21 days)
For the in vitro quantitative determination of troponin T in human serum and plasma.
The specificity and sensitivity of troponin T measurements aid in both the early and late diagnosis of AMI. Troponin T elevations have also been measured in patients with the clinical diagnosis of unstable angina due to the sensitivity of troponin T for detecting minor myocardial damage.
The determination of cTnT in serum is an important component in the diagnosis of myocardial ischemia, e.g. AMI and myocarditis, as well as in monitoring the course of unstable angina pectoris and assessing the associated risk.
The Boehringer Mannheim Elecsys ® Troponin T STAT test is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined via a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
This document describes the Boehringer Mannheim Elecsys® Troponin T STAT Test, an immunoassay for the quantitative determination of troponin T in human serum and plasma, used in the diagnosis of myocardial ischemia.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific acceptance criteria or provide a table summarizing device performance metrics against such criteria. It mentions "Specific data on the performance of the test have been incorporated into the draft labeling in Attachment 5," but this attachment is not included in the provided excerpts.
The document primarily focuses on establishing substantial equivalence to a predicate device, the Boehringer Mannheim Elecsys® Troponin T test (cleared by FDA in K961500), rather than detailing performance specifications and meeting predefined acceptance thresholds for this particular iteration of the device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Comparative studies on 770 patients confirm the prognostic utility of cTnT." This appears to be the sample size for a clinical study related to the prognostic utility of cTnT, which supports the "Indications for Use." However, it's not explicitly stated if this 'test set' was for the modified device's performance validation against specific acceptance criteria, or if it refers to general clinical evidence for Troponin T as a biomarker.
- Sample Size (for prognostic utility): 770 patients.
- Data Provenance: Not specified regarding country of origin.
- Retrospective or Prospective: Not specified.
It's important to note that this is for the prognostic utility of cTnT, not necessarily the performance characteristics (e.g., accuracy, precision) of the device itself. The actual performance data for the device is referenced as being in "Attachment 5," which is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the given text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. 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
This device is an in vitro diagnostic (IVD) immunoassay; it is not an AI-assisted diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is an in vitro diagnostic immunoassay. Its performance is inherently standalone in the sense that the test produces quantitative results directly. There is no "human-in-the-loop" component in the interpretation of the raw quantitative troponin T value produced by the instrument and reagent, although a clinician interprets the clinical significance of that value.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "Comparison to the Predicate Device," the ground truth implicitly is the performance of the predicate device. For the "Indications for Use" and the prognostic utility cited ("Comparative studies on 770 patients confirm the prognostic utility of cTnT"), the ground truth would likely be clinical outcomes data related to cardiac events and patient prognosis. However, the exact methodology for establishing specific ground truth for the device's analytical performance (e.g., accuracy, precision) is not described in the provided text, other than through comparison to the predicate.
8. The sample size for the training set
The concept of a "training set" as understood in machine learning (ML) or AI is not applicable to this traditional immunoassay device. Immunoassays do not have training sets in this sense. They are developed based on chemical and biological principles, and their performance is validated through analytical and clinical studies.
9. How the ground truth for the training set was established
As noted above, the concept of a "training set" is not applicable to this type of device.
§ 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.