(116 days)
The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage.
Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
The Access AccuTnl reagents, AccuTnl calibrators, and the Access and Access 2 Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac troponin I in human serum and plasma.
The provided document describes the Beckman Coulter AccuTnl™ and AccuTnl Calibrators on the Access® Immunoassay Systems. This device is an in-vitro diagnostic test, not an AI/ML-driven device. Therefore, the questions related to AI/ML specific criteria (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.
However, I can extract the acceptance criteria related to analytical performance and clinical effectiveness for this diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
The document references a previous 510(k) submission (K010429) where the analytical studies were summarized. For the current submission (K021814), the focus is on the clinical performance for risk stratification.
| Acceptance Criteria Category | Specific Criteria/Outcome Measured | Reported Device Performance |
|---|---|---|
| Analytical Studies | Precision, Analytical Sensitivity, Dilution Recovery (Linearity), Method Comparison, Matched Sample Comparison, Analytical Specificity, Stability, Reference Intervals, Equimolarity | No changes made to assay reagents from K010429. Results from K010429 serve as predicate for analytical performance. |
| Clinical Performance (Risk Stratification) | Relative Risks (RR) and Odds Ratios (OR) for adverse cardiac events (double and triple composite endpoints). | At the 97.5th percentile of the reference range: |
- RR and OR for double & triple composite endpoints ranged from 1.68 to 3.61 across 3 follow-up periods.
- All were statistically significant.
At the 99th percentile of the reference range: - RR and OR for double & triple composite endpoints ranged from 1.58 to 3.18 across 3 follow-up periods.
- All were statistically significant.
At the median concentration at 10% CV imprecision: - RR and OR for double & triple composite endpoints ranged from 1.62 to 3.60 across 3 follow-up periods.
- All were statistically significant. |
| Intended Use Expansion Justification | Demonstration that the assay can stratify patients for potential adverse cardiac events. | The data demonstrate that the Access AccuTnl assay can be utilized to stratify patients for potential adverse cardiac events (double and triple composite endpoints) using three cutoffs at three follow-up periods. |
Study that Proves the Device Meets the Acceptance Criteria:
The current submission (K021814) primarily focuses on demonstrating the clinical utility of the AccuTnl assay for risk stratification by analyzing its performance against various clinical endpoints over different follow-up periods and at different cutoffs. The analytical performance is established by referencing the prior 510(k) (K010429).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the clinical performance study (test set) or its provenance (country of origin, retrospective/prospective nature). It only provides the summarized results of the clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is an in-vitro diagnostic device that measures a biomarker. The "ground truth" here pertains to clinical outcomes (death, myocardial infarction, urgent revascularization) rather than expert interpretation of images or other subjective data. These outcomes are typically objectively recorded in patient medical records.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" refers to objective clinical endpoints.
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 an in-vitro diagnostic biomarker test, not an AI-assisted diagnostic imaging device/system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. It's an immunoassay that provides a quantitative measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical performance study appears to be outcomes data, specifically "double composite endpoint consisting of death or myocardial infarction and triple composite endpoint consisting of death or myocardial infarction or urgent revascularization." These are objective clinical events.
8. The sample size for the training set
Not applicable. This is an immunoassay, not an AI/ML device that requires a training set in the typical sense. The assay itself is developed and validated, but there isn't a "training set" of patient data for an algorithm.
9. How the ground truth for the training set was established
Not applicable. See response to #8.
§ 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.