(76 days)
The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.
The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System.
The provided text describes a 510(k) summary for the Abbott AxSYM® Troponin-I ADV assay. This is an in vitro diagnostic (IVD) device, and the evaluation for such devices often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on clinical outcomes or improved human reader performance in the same way a software-as-a-medical-device (SaMD) might be evaluated.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The study aims to demonstrate substantial equivalence between the Abbott AxSYM® Troponin-I ADV assay and the Beckman Coulter Access® AccuTnI assay. The acceptance criteria for analytical performance typically involve correlation and agreement statistics between the new device and the predicate.
| Acceptance Criterion | Reported Device Performance (AxSYM Troponin-I ADV vs. Beckman Coulter Access AccuTnI) |
|---|---|
| Passing-Bablok Regression (All Specimens) | |
| Correlation Coefficient (r) | 0.97 |
| Slope | 1.47 |
| Intercept | -0.05 |
| Passing-Bablok Regression (ADV Dynamic Range) | |
| Correlation Coefficient (r) | 0.95 |
| Slope | 1.47 |
| Intercept | -0.05 |
Note on Acceptance Criteria: The specific numerical acceptance criteria (e.g., minimum 'r' value, acceptable range for slope and intercept) are not explicitly stated in this summary. However, given the FDA's clearance, it can be inferred that the reported performance values met the internal and FDA's requirements for demonstrating substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- All Specimens: n = 546
- ADV Dynamic Range: n = 531
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is clinical sample data used for method comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
For IVD devices like this, particularly when demonstrating substantial equivalence via method comparison, the "ground truth" is typically the result obtained from the predicate device (the Beckman Coulter Access® AccuTnI assay). There isn't an "expert" panel establishing a consensus ground truth in the way one might for image-based diagnostic AI. The predicate device itself serves as the reference standard.
4. Adjudication Method
Not applicable for this type of IVD device evaluation. Adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers are interpreting imaging or clinical data, and a consensus ground truth needs to be established. Here, the comparison is directly between two analytical assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is not relevant for an IVD assay like the Abbott AxSYM® Troponin-I ADV.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Yes, in a sense, a standalone performance study was done. The performance metrics (correlation, slope, intercept) compare the Abbott AxSYM® Troponin-I ADV assay (the "algorithm" in this context) directly against the predicate device without human intervention influencing the assay's output. The device is intended for quantitative determination, and its output is a numerical value, not an interpretation requiring a human in the loop for diagnosis.
7. The Type of Ground Truth Used
The ground truth or reference standard was the performance of the legally marketed predicate device: the Beckman™ Coulter Access® AccuTnI assay. The study aimed to show that the new device's quantitative measurements of cardiac troponin-I were highly correlated and in agreement with those obtained from the predicate device.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. For traditional IVD assays, there isn't typically a distinct 'training set' in the same way there is for AI/ML models. The development and optimization of the assay reagents and parameters would have occurred prior to this substantial equivalence study, but the specific sample sizes for those developmental phases are not provided. The numbers cited (546 and 531) refer to the test set used for the method comparison study to demonstrate substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" with established ground truth, as understood in AI/ML, doesn't directly apply here. The Abbott AxSYM® Troponin-I ADV is a microparticle enzyme immunoassay, not an AI/ML algorithm that learns from data. Its "ground truth" for development would involve analytical accuracy, precision, linearity, and other performance characteristics established against known standards or reference materials during product development.
§ 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.