(66 days)
The AxSYM Troponin-I ADV assay 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)
The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma.
The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-l in human serum or plasma.
The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunassay for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV assay is calibrated with AxSYM Troponin-I ADV Standard Calibrators. AxSYM Troponin-I ADV Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
Acceptance Criteria and Study for Abbott AxSYM® Troponin-I ADV Assay
This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Abbott AxSYM® Troponin-I ADV assay to the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the substantial equivalence claim relies on a correlation analysis between the new device and a predicate device. The acceptance criteria are implicitly defined by the demonstration of a strong correlation (high R-value) and a slope close to 1, with an intercept close to 0, which would indicate similar measurements between the two assays. While explicit numerical thresholds for acceptance (e.g., minimum R, range for slope and intercept) are not provided, the reported performance is presented to demonstrate this similarity.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Abbott AxSYM® Troponin-I ADV vs. Beckman Coulter™ Access® AccuTnI) |
|---|---|---|
| Correlation (R) | High (close to 1) | 0.97 (All Specimens) |
| 0.95 (ADV Dynamic Range) | ||
| Slope | Close to 1.0 | 1.47 (All Specimens) |
| 1.47 (ADV Dynamic Range) | ||
| Intercept | Close to 0.0 | -0.05 (All Specimens) |
| -0.05 (ADV Dynamic Range) |
Note: The reported slope of 1.47 indicates a potential systematic difference where the Abbott AxSYM® device may be reading higher values than the predicate device. However, the FDA has deemed this acceptable for substantial equivalence in this context.
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- All Specimens: 546
- ADV Dynamic Range: 531
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it is generally expected that studies are conducted with specimens from human sources, and frequently these are done through clinical studies in a prospective or mixed fashion, but this specific detail is not provided.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This study is a comparative effectiveness study between two diagnostic devices, not a study evaluating human expert performance against a "true" ground truth in the traditional sense (e.g., identifying disease from an image). The "ground truth" for the comparison is the measurement provided by the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a direct comparison between two quantitative assays. There is no human adjudication process involved in establishing the "ground truth" (i.e., the predicate device's measurement).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described. This submission pertains to an in-vitro diagnostic device (an assay), not an imaging device or algorithm designed to be interpreted by human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. Standalone Performance Study
Yes, a standalone performance study was done for the Abbott AxSYM® Troponin-I ADV assay by comparing its measurements directly against an established predicate device. The results of this comparison (correlation, slope, intercept) demonstrate the standalone performance of the algorithm (assay method). It measures quantitative determination of cardiac troponin-I in human serum or plasma without human intervention in the measurement process itself, beyond sample handling.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative measurement provided by the Beckman Coulter™ Access® AccuTnI assay, which is explicitly stated as the predicate device. This is a form of comparative ground truth against an established, legally marketed device.
8. Sample Size for the Training Set
Not applicable. This 510(k) summary describes a device comparison study for market clearance, not an AI or machine learning model development where a training set would be explicitly used to develop the algorithm itself. The AxSYM® Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA), a well-established biochemical assay technology. The reported "n" values (546 and 531) refer to the number of specimens used in the comparability study, which serves as the "test set" for demonstrating substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI/ML algorithm being developed. For the development of the assay itself (e.g., establishing its reagents, calibration, and measurement principles), extensive internal R&D and validation would have occurred. However, the 510(k) submission focuses on the clinical performance comparison against a predicate for regulatory clearance.
§ 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.