(28 days)
The cardiac troponin I (TROP) TestPak used on the Stratus® CS STAT Fluorometric Analyzer is an in vitro diagnostic product for the measurement of cardiac troponin I in heparinized plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The TROP TestPak consists of a plastic cartridge with five wells and a small square of glass fiber paper embedded in it. The method utilizes a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody specifica for cardiac troponin I is added to the center portion of a square piece of glass fiber paper in the TROP TestPak. Sample is then added onto the paper where it reacts with the immobilized troponin antibody. After a short incubation, a conjugate consisting of enzyme-labeled antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound antigen, forming an antibodyantigen-labeled antibody sandwich. The unbound, labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone of the TestPak. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of caridac troponin I in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer.
The provided text is a 510(k) summary for the Dade Behring Stratus® CS Cardiac Troponin I (TROP) TestPak. It describes a modification to an existing device (changing the recommended QC frequency). Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new device submission. This document solely focuses on demonstrating that a change in labeling (QC frequency) does not adversely affect performance and that the modified device remains substantially equivalent to the predicate.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer the questions based only on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision) or specific numerical targets. It implies that the predicate device (K981098) met its acceptance criteria, and the current submission's "performance" is focused on demonstrating that the change in QC frequency does not adversely affect the performance of the device.
| Acceptance Criteria | Reported Device Performance (related to QC change) |
|---|---|
| (Not explicitly stated in terms of performance metrics for a new device) | "The QC data collected supports the recommended change in QC frequency and indicates the change will not adversely affect performance 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)
This information is not provided in the document. The document mentions "QC data collected" but does not specify the sample size, type of data (patient samples vs. control materials), or provenance.
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 applicable and not provided. The study is about the performance of a diagnostic assay, not an imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. This relates to establishing ground truth for subjective assessments, which is not the nature of this submission.
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
Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an in vitro diagnostic (IVD) assay run on an analyzer. Its performance is inherently "standalone" in the sense that the analyzer provides a quantitative result without direct human interpretation of a visual output. However, the document doesn't detail performance studies in this context, only that the QC frequency change doesn't adversely affect performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the "QC data." For an IVD assay measuring a biomarker like cardiac troponin I, ground truth would typically be established by reference methods or clinical diagnosis based on a combination of clinical presentation, ECG, and other biomarker levels. However, the document does not elaborate on how "ground truth" was established for the QC data.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device with a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI 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.