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The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum, using the ACCESS® Immunoassay System.
Here's a breakdown of the acceptance criteria and study details for the ACCESS® Troponin I assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary doesn't explicitly state pre-defined acceptance criteria with specific numerical targets. Instead, it describes key performance metrics and then concludes that the device demonstrates "acceptable diagnostic efficiency" and "substantially equivalent performance" to predicate devices. Below, I've listed the reported performance metrics that would likely have been part of the implicit acceptance criteria for such a device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision (CV) | Acceptable range for high/low controls | 5.97% CV (high control) to 13.53% CV (low control) |
| Dilution Recovery | Acceptable average recovery percentage | 93.5% |
| Correlation with Predicate | Strong correlation (r value, regression equation) | r = 0.87, y = 0.136x -0.088 (vs. Stratus® Cardiac Troponin I) |
| Analytical Sensitivity | Lowest detectable level distinguishable from zero | 0.03 ng/ml (95% confidence) |
| Clinical Performance | ||
| Clinical Sensitivity (AMI) | Acceptable sensitivity at optimal cutoff | 89% (at 0.15 ng/ml cutoff) |
| Clinical Specificity (AMI) | Acceptable specificity at optimal cutoff | 91% (at 0.15 ng/ml cutoff) |
| Concordance with Predicate | High agreement percentage with predicate troponin I assay | 90% concordant with Stratus® Troponin I |
| Concordance with Gold Standard | High agreement percentage with gold standard (CK-MB) | 90% concordant with CK-MB |
| Specificity in Skeletal Injury | Acceptable specificity in confounds (skeletal injury) | 86% (in 58 skeletal injury patients) |
| Specificity in Renal Disease | Acceptable specificity in confounds (renal disease) | 96% (in 81 renal disease patients) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- AMI rule-in/rule-out: 289 subjects
- Correlation with Stratus® Troponin I: 201 patients
- Correlation with CK-MB: 208 subjects
- Skeletal muscle injury specificity: 58 patients
- Renal disease specificity: 81 subjects
- Data Provenance: The study was a "multi-site prospective study" where subjects presented to the emergency department with chest pain. While specific countries are not mentioned, the context (FDA 510(k) in the US) typically implies US-based clinical sites unless otherwise specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The summary does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth (diagnosis of AMI). However, given that it's a clinical study for ruling in/out AMI, it's highly probable that physicians (e.g., emergency physicians, cardiologists) were involved in determining the final diagnosis based on standard clinical practice, including clinical presentation, ECG changes, and serial biomarker measurements. The "diagnosis" would have been established using comprehensive clinical criteria, not solely a single expert's opinion.
4. Adjudication Method for the Test Set
The summary does not specify an explicit adjudication method (e.g., 2+1, 3+1). The diagnosis of AMI in the "rule-in or rule-out AMI" study context would likely have been based on established clinical guidelines and physician judgment, rather than a formal, multi-reader consensus process as seen in imaging studies. Each patient contributed a minimum of two serum samples to establish the diagnosis, implying a longitudinal assessment was part of the diagnostic process.
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 is more common for imaging devices where human readers interpret images with and without AI assistance. This submission describes an in-vitro diagnostic (IVD) immunoassay, where the device provides a quantitative numerical result, not an interpretation that human readers would directly assist with. Therefore, comparing human reader performance with and without AI assistance is not applicable in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the study primarily evaluates the standalone performance of the ACCESS® Troponin I assay. The reported sensitivity, specificity, and concordance values are for the device itself, providing its quantitative measurement and diagnostic classification without human interpretation of its output. The device outputs a numerical value, and then a cutoff (0.15 ng/ml) is applied to classify the result.
7. The Type of Ground Truth Used
The ground truth for Acute Myocardial Infarction (AMI) was established through clinical diagnosis based on standard medical practice, referred to as "rule-in or rule-out AMI." This would involve a combination of:
- Clinical presentation (chest pain of 20 minutes duration).
- Serial serum samples (minimum of two) to observe changes in cardiac biomarkers.
- Presumed other clinical data (e.g., ECG findings, medical history), though not explicitly detailed in the summary.
- The comparison to CK-MB, which was considered the "current gold standard biochemical marker" at the time, also served as a reference for establishing the clinical utility of troponin I.
8. The Sample Size for the Training Set
The summary does not provide details on a separate training set size. It describes a "multi-site prospective study" that appears to serve as the primary clinical validation (test set). For IVD devices like this immunoassay, the "training" (development/calibration) of the assay itself occurs during the manufacturing and R&D phases to optimize reagents, calibrate reference materials, and establish analytical performance characteristics. These are typically not reported as a "training set" in the same way an AI/ML model would describe it. The 289 subjects likely contributed to the clinical evaluation, and no distinction is made for a separate training portion.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with independent ground truth establishment, as typically understood in AI/ML, isn't described for this IVD device. The development and analytical characterization of the assay (e.g., determining linearity, precision, analytical sensitivity) would have involved laboratory experiments with known concentrations of troponin I and clinical samples, but this is part of assay development rather than a ground truth establishment for an AI training set.
§ 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.