(85 days)
The Troponin I (cTn) assay for the Opus™ Immunoassay System is used to quantitatively measure cardiac troponin I in serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
The Opus™ Troponin I (cTn) assay is a two-site or sandwich fluorogenic enzyme linked immunoassay. Dendrimer linked monoclonal antibody is precoated onto a piece of glass fiber paper in the cTn Test Module. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule.
The OpusTM System pipettes patient sample from a sample cup and dispenses it onto the glass fiber paper where it reacts with immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the cardiac troponin I molecule is pipetted from a sealed well within the test module, onto the reaction zone of the paper. During a second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibodyantigen-labeled antibody sandwich. A substrate wash solution is pipetted from a second sealed well on the test module, to the wash port. Unbound labeled antibody is eluted away from the optical read window of the Opus™ System through lateral capillary action. The substrate, 4-methylumbelliferyl phosphate is included within the wash solution allowing simultaneous substrate conversion with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by the instrument's optical system.
The provided document is a 510(k) premarket notification for an in vitro diagnostic device, the Opus™ Troponin I (cTn) Test Modules. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or threshold format. Instead, it uses a substantial equivalence approach, comparing the performance of the new device to a legally marketed predicate device. The primary performance metric reported is a correlation between the two devices.
| Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Opus™ Troponin I vs. Dimension® RxL Troponin I) |
|---|---|---|
| Correlation Coefficient (r) | High correlation (close to 1) | 0.9856 |
| Slope | Close to 1.0 | 1.01 |
| Intercept | Close to 0 ng/mL | 0.1516 ng/mL |
| Principle of procedure | Similar to predicate | Sandwich format monoclonal antibody immunoassay |
| Monoclonal Antibodies (Tag) | Identical to predicate | 2B1.92F6.6 |
| Type of measurement | Similar function (quantitative) | Fluorogenic (Predicate: Colorimetric) |
| Solid Support | Similar function (platform) | Glass fiber paper (Predicate: Chromium Oxide) |
| Specimen type | Identical to predicate | serum or heparinized plasma |
| Sample Size | Appropriate for method | 25µL (Predicate: 60µL) |
| Intended Use | Identical to predicate | Same stated intended use |
| Indications for Use | Identical to predicate | Same stated indications for use |
Note: The acceptance criteria are "implied" because the document states the device is "substantially equivalent in principle and performance" based on the comparison metrics. A correlation coefficient of 0.9856, a slope of 1.01, and an intercept of 0.1516 ng/mL between the two methods are considered strong evidence for substantial equivalence in the context of clinical immunoassay comparisons.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 132 clinical patient samples.
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated, but the phrase "clinical patient samples ranging from 0.16 - 45.95 ng/mL" suggests real-world samples, the collection method (retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable to this submission. The study is a method comparison study (split sample comparison) comparing a new device (Opus™) to a predicate device (Dimension® RxL Troponin I). The "ground truth" for the test set is effectively the result provided by the predicate device, or a reference method if the predicate was also being validated against one. There is no mention of human experts interpreting results or establishing a "ground truth" classification for the samples in this context.
4. Adjudication Method for the Test Set
Not applicable. As this is a method comparison study between two analytical devices, rather than a diagnostic interpretation study involving human readers, there is no expert adjudication process described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC study was not done. This document describes the analytical performance of an in vitro diagnostic device, not the interpretive performance of human readers, with or without AI assistance. Therefore, there is no discussion of human reader improvement with AI.
6. Standalone Performance Study
Yes, a form of standalone performance was implicitly done. The "split sample comparison" tests the Opus™ device in its intended operational mode, providing quantitative results directly comparable to the predicate device. The results (correlation, slope, intercept) demonstrate the analytical standalone performance characteristics of the Opus™ device when analyzing patient samples.
7. Type of Ground Truth Used
The "ground truth" in this context is established by the predicate device, the Dimension® RxL Troponin I assay. The study implicitly assumes the predicate device provides accurate measurements of cardiac troponin I, and the goal of the Opus™ device is to provide quantitatively similar results.
8. Sample Size for the Training Set
Not applicable. This device is an immunoassay system, not an AI/ML-based diagnostic algorithm that requires a "training set." The system's performance is based on its chemical and optical principles, not on learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described 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.