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510(k) Data Aggregation
(89 days)
VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
- The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
This 510(k) summary describes the VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators, and Range Verifiers, designed for the quantitative measurement of cardiac Troponin I (cTnI). The submission aims to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device are implied by a comparison to a predicate device (BECKMAN Access® AccuTnI Troponin I assay) and various clinical and analytical standards. The document primarily focuses on establishing "substantial equivalence" rather than specific numerical acceptance criteria for each performance characteristic. However, the listed "Differences" section in Table 1 can be interpreted as the reported device performance compared to specific characteristics of the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (VITROS Troponin I ES) |
|---|---|---|
| Intended Use | Similar to predicate | For quantitative measurement of cTnI in human serum and plasma (heparin and EDTA) to aid in assessment of myocardial damage and risk stratification. Aids in diagnosis of acute MI and risk stratification of non-ST-segment elevation acute coronary syndromes. |
| Basic Principle | Chemiluminescence Immunoassay | Solid phase immunoassay (Note: Predicate is 2-site immunoenzymatic, both are chemiluminescence) |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Sample Type | Serum and plasma (heparin and EDTA) | Serum and plasma (heparin and EDTA) |
| Organizations Used/Referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO |
| Lower Limit of Detection | Generally acceptable sensitivity | 0.012 ng/mL (Note: Predicate "Not applicable" for this specific metric) |
| Sample Volume | Not explicitly defined as acceptance criteria for new device, but a comparative point of difference. | 80 µL |
| Measuring Range | Broad enough for clinical utility | 0.012-80.0 ng/mL |
| Analytical Sensitivity | Comparable to predicate | <0.009 ng/mL (Predicate: 0.01 ng/mL) |
| Hook Effect | None within clinical range | None up to 14,000 ng/mL (Predicate: None up to 1,920 ng/mL) |
| Expected Values: 99th percentile URL | Clinically appropriate (e.g., comparable to predicate) | 0.034 ng/mL (Predicate: 0.04 ng/mL) |
| AMI Cut off | Clinically appropriate sensitivity and specificity | 0.120 ng/mL (95% sens., 93% spec.) (Predicate: 0.50 ng/mL (96% sens., 94% spec.)) |
| 10% CV | Clinically acceptable precision | 0.034 ng/mL (Predicate: 0.06 ng/mL) |
| Spec. & Sens over time (0 to 24 hrs.) | Clinically acceptable performance over time | Sens. Range 69-90%, Spec. Range 94-96% (Predicate: Sens. Range 46-91%, Spec. Range 96-88%) |
| CLSI Standards Used/Referenced | Adherence to relevant standards | C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29 (Predicate: EP6-P, EP5-A, EP7-P) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary provides limited detail on the specific study design and sample sizes for performance evaluation. It lists several CLSI (Clinical and Laboratory Standards Institute) standards used or referenced (e.g., C24, EP5, EP6, EP7, EP9, EP17, C28, GP10, H3, H4, M29). These standards typically outline methods for determining analytical validity, including precision, accuracy, linearity, and sensitivity/specificity. However, the document does not explicitly state the sample sizes used for various test sets, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Given that this is an in-vitro diagnostic device for measuring a biomarker, the "ground truth" would typically be established based on accepted clinical definitions of myocardial infarction and acute coronary syndromes, potentially involving cardiologist diagnoses, clinical outcomes, and the results from a predicate device or a reference method. The document does not mention the involvement of experts for ground truth establishment for the test set.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide any information regarding an adjudication method for the test set. For an immunoassay, the "ground truth" is typically the measured concentration of the analyte, verified against established clinical cut-offs or comparative methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable as the device described is an in-vitro diagnostic immunoassay for quantitative measurement of Troponin I, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an in-vitro diagnostic assay for measuring a biomarker. The device itself (the immunoassay system) operates in a standalone manner to generate quantitative results. The performance metrics presented (analytical sensitivity, measuring range, hook effect, 99th percentile URL, AMI cut-off sensitivity/specificity, 10% CV) are inherent to the algorithm and chemical reactions of the assay and represent its standalone performance. The human "in-the-loop" aspect would be a clinician interpreting the numerical result in the context of a patient's overall clinical presentation.
7. The Type of Ground Truth Used
The ground truth for this device is based on several elements:
- Expert Consensus/Clinical Criteria: The "Indications for Use" explicitly state the device aids in the diagnosis of acute myocardial infarction and risk stratification based on established clinical understanding of cardiac Troponin I. The reference to organizations like NACB, ESC/ACC/AHA, and WHO further supports this.
- Comparison to Predicate Device: Substantial equivalence is established through direct comparison to the BECKMAN Access® AccuTnI Troponin I assay, implying that the predicate's established performance serves as a benchmark for the new device's ground truth and clinical utility.
- Analytical Performance Metrics: The analytical performance data (e.g., analytical sensitivity, measuring range, precision/CV, hook effect) are assessed against established laboratory and clinical standards (like CLSI guidelines), which serve as the "ground truth" for the device's technical specifications.
- AMI Cut-off/Sensitivity/Specificity: The reported AMI cut-off with associated sensitivity and specificity indicates that clinical diagnoses of AMI (presumably established through independent clinical criteria, though not detailed here) were used as a "ground truth" to determine the diagnostic performance of the assay.
8. The Sample Size for the Training Set
The 510(k) summary does not provide information about a specific "training set" size. For an immunoassay, the development process involves extensive analytical testing and optimization (which could be considered analogous to "training" in a broader sense), but these details are not typically disclosed as specific sample sizes for a 'training set' in the context of machine learning. The focus here is on the analytical and clinical validation studies demonstrating performance.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is identified in the context of an AI/machine learning model, the establishment of ground truth for a training set is not applicable in the documented submission. The "ground truth" for the development and validation of the assay involves the iterative process of developing reagents and calibrators, testing their analytical performance against known standards and established clinical samples, and comparing results to predicate devices, adhering to industry guidelines (e.g., CLSI).
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