(17 days)
AxSYM® Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System. Measurements obtained by this device aid in the rapid diagnosis of heart or renal disease.
AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma. AxSYM Myoglobin is calibrated with Abbott AxSYM Myoglobin Calibrators. Abbott AxSYM Myoglobin Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.
This submission describes the Abbott AxSYM® Myoglobin assay, a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma. The study aims to demonstrate substantial equivalence to the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are based on a comparison to a predicate device, the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The reported performance demonstrates a strong correlation between the two assays.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (AxSYM Myoglobin vs. Dade Stratus Myoglobin) |
|---|---|---|
| Correlation Coefficient (r) | High correlation (implied by "substantially equivalent") | 0.981 |
| Slope (Least Squares Linear Regression) | Close to 1.0 (implied by "substantially equivalent") | 1.09 (95% CI: 1.07 to 1.11) |
| Y-axis Intercept (Least Squares Linear Regression) | Close to 0 (implied by "substantially equivalent") | 1.0 ng/mL (95% CI: -3.7 to 5.7) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 383 specimens.
- Data Provenance: Not explicitly stated, but clinical specimens are implied for a device intended for human serum or plasma testing. The submission does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This study is a comparative effectiveness study between two diagnostic assays, not an AI-based image analysis or expert review process. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical adjudication is not applicable here. The ground truth for the comparison is the measurement obtained by the predicate device (Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay).
4. Adjudication Method for the Test Set
Not applicable. This is a measurement comparison study, not a study involving expert adjudication of clinical findings.
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 MRMC study and does not involve AI assistance or human readers. It is a direct comparison between two in vitro diagnostic assays.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this can be considered a standalone performance study. The Abbott AxSYM Myoglobin assay's performance is assessed independently against a predicate device, without human intervention in the assay's execution or result interpretation beyond standard laboratory procedures. The "algorithm" here refers to the MEIA methodology of the AxSYM system itself.
7. The type of ground truth used
The "ground truth" for this substantial equivalence study is the measurements provided by the legally marketed predicate device, the Dade Stratus® Myoglobin Fluorometric Enzyme Immunoassay. The comparison aims to show that the new device's measurements are equivalent to those of the established predicate.
8. The sample size for the training set
Not applicable. This is not a machine learning study where a "training set" in the computational sense is typically used. The development of the AxSYM Myoglobin assay would have involved its own internal validation and optimization, but the submission describes a performance comparison, not a training process for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no explicitly defined "training set" in the context of this 510(k) submission. The ground truth for the comparative study (test set) is the predicate device's results.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).