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510(k) Data Aggregation
(168 days)
The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.
The RAMP Troponin I Assay is a quantitative immunochromatographic test for the rnic Tric Troponia T-Thous) Do A whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip our pro real blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-Tril antibodies hightion and in the sample. As the sample migrates along the strip, Tnl bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone. The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.
This document describes the RAMP Troponin I Assay, a quantitative immunochromatographic test for measuring cardiac troponin I levels in EDTA whole blood, intended to aid in the rapid diagnosis of acute myocardial infarction (AMI).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria for performance metrics such as precision, linearity, or analytical sensitivity. Instead, it provides performance characteristics and then concludes that the device is "substantially equivalent" to predicate devices. For a regulatory submission like a 510(k), substantial equivalence implies that the device performs as well as or better than existing legally marketed devices.
However, we can infer some criteria and list the reported performance:
| Performance Characteristic | Reported Device Performance (RAMP Troponin I Assay) |
|---|---|
| Precision | |
| Intra-assay CV | 8.7% and 8.3% (at 1.05 and 5.01 ng/mL Tnl) |
| Total precision CV | 10.0% and 8.3% (at 1.05 and 5.01 ng/mL Tnl) |
| Low end precision (CV ≤ 10%) | 0.21 ng/mL Tnl (within run), 0.15 ng/mL Tnl (total), 0.10 ng/mL Tnl (whole blood) |
| Low end precision (CV ≤ 20%) | 0.14 ng/mL Tnl (within run) |
| Linearity (R value) | 0.997 |
| Slope | 1.019 |
| Offset | 0.279 |
| Percent Recovery | 95 to 115% (average 105%) |
| Hook Effect | No high dose hook effect up to 500 ng/mL Tnl |
| Lower Limit of Detection (LLD) | 0.03 ng/mL Tnl |
| Upper Reportable Limit | > 32 ng/mL Tnl |
| Cross-reactivity | No significant cross-reactivity with Skeletal Troponin I, Cardiac Troponin T, Cardiac Troponin C. Minimal with HAMA, HAGA, HARA, RhF. |
| Interference | No evidence of cross-reactivity or interference with hemoglobin, triglyceride, bilirubin, cholesterol, heparin at very high physiological concentrations. |
| Method Comparison (vs. Dimension) - Combined Pop. R value | 0.988 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision Study Test Set:
- Sample Size: 184 subjects (55 normal individuals, 129 patients suspected of AMI).
- Provenance: Samples were selected from those obtained during the Method Comparison Study. The document does not explicitly state the country of origin but implies a clinical setting via "individual hospital criteria." It indicates the samples were retrospective for the precision study, as they were "stored refrigerated for up to one day between analyses" and subsequently analyzed in duplicates "over 10 days."
- Method Comparison Study Test Set:
- Sample Size: 365 subjects (180 normal individuals, 185 patients suspected of AMI).
- Provenance: The samples were obtained from subjects where "EDTA and heparin whole blood samples were obtained for each of these subjects." "All normal subjects were consented. Waste samples were used for the subjects suspected of AMI." This suggests a prospective collection for this specific study for the normal subjects, and potentially retrospective or waste samples for the AMI subjects. Country of origin is not specified but the submission is to the FDA, implying US or internationally recognized standards.
- Expected Values (Normal Range) Study Test Set:
- Sample Size: 180 healthy individuals.
- Provenance: "Whole blood samples from 180 healthy individuals... were assayed". This implies a prospective collection from a healthy population.
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)
The studies described are for an in-vitro diagnostic device measuring a biomarker (Troponin I). The "ground truth" here is the actual concentration of Troponin I in the samples. This is typically established by reference methods or comparison to legally marketed predicate devices, not by human expert consensus or radiologists.
- For the Method Comparison Study, the Dimension® RxL Cardiac Troponin-I Flex® assay (a predicate device, K973650) served as a reference for comparison, implying its results were considered a form of "ground truth" or a highly reliable comparator. The data was also compared to the Triage Cardiac Panel®, another predicate device.
- For analytical performance (precision, linearity, LLD), the ground truth is established by preparing known concentrations of the analyte (Tnl antigen) in a controlled laboratory setting.
Therefore, the concept of "experts" establishing ground truth in the way described (e.g., radiologists) is not applicable to this type of device and study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between readers need to be resolved. This document describes studies for an automated in-vitro diagnostic device measuring a biomarker. Therefore, no adjudication method of this type was used or is relevant. The device output is a quantitative measurement.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on the impact of a device (often AI-based) on human reader performance, which is not applicable to an automated quantitative immunoassay like the RAMP Troponin I Assay. The device provides a direct numerical measurement of a biomarker, not an interpretation that human readers would "improve with."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described are inherently standalone algorithm performance studies. The RAMP Troponin I Assay, in conjunction with the RAMP Reader, is an automated system that provides quantitative measurements. The performance characteristics (precision, linearity, analytical sensitivity, hook effect, cross-reactivity, interference, and method comparison) are all evaluating the device's ability to accurately measure Troponin I concentrations directly, without human interpretation of the assay's output influencing the direct measurement itself. The "human-in-the-loop" aspect for this device would be the clinician's interpretation of the numerical result in the context of patient symptoms, not the interpretation of the assay output itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The primary "ground truth" used for this quantitative assay comprises:
- Known concentrations of analyte: For analytical sensitivity, linearity, and recovery studies, known concentrations of Tnl antigen were prepared and used as the reference.
- Results from legally marketed predicate devices: For the method comparison study, the Dimension® RxL Cardiac Troponin-I Flex® Assay and Triage Cardiac Panel® Troponin I Assay were used as comparators, providing a "ground truth" for clinical sample concentrations.
This is distinct from ground truth based on expert consensus, pathology, or outcomes data, which are more common for diagnostic imaging or clinical prediction models.
8. The sample size for the training set
The document does not explicitly describe a "training set" in the context of machine learning or AI models, as this is a chemical immunoassay, not a software algorithm that learns from data.
However, if we consider "training" in a broader sense related to assay development and optimization (e.g., determining assay parameters, reagent concentrations), that information is not provided as part of this 510(k) summary. The summary focuses on the final performance validation of the developed assay.
9. How the ground truth for the training set was established
As there is no "training set" described in the machine learning sense, this question is not fully applicable. For the development and establishment of the assay itself (analogous to "training" certain parameters), the ground truth would have been established through controlled laboratory experiments using purified Troponin I antigens at known concentrations and characterization against reference materials. However, details of this developmental phase are not included in the 510(k) "Summary of Studies," which focuses on performance verification.
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