Search Results

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:

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.

Ask a specific question about this device

The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm.

The RAMP™ Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

The RAMP Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

Diluted EDTA whole blood is applied into the sample well of the Test Cartridge. The red blood cells are retained in the sample pad, and the separated plasma migrates along a strip, through a contact zone where it interacts with fluorescent latex particles. Latex (test) particles, coated with mouse monoclonal anti-myoglobin antibodies bind to myoglobin in the sample.

The sample moves by capillary action towards the end of the strip. As the sample migrates to the detection zone, myoglobin anti-myoglobin 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 regulatory submission for the RAMP™ Myoglobin Assay and RAMP Reader.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of pass/fail thresholds for clinical performance but are implied by demonstrating substantial equivalence to predicate devices through correlation. The reported device performance is presented as correlation coefficients (r), slopes, and intercepts from method comparison studies, and precision data.

2. Sample Size Used for the Test Set and Data Provenance

• Method Comparison Study (vs. Beckman ACCESS Myoglobin Assay):
  • Test Set Size: 415 subjects (196 normal individuals, 219 patients suspected of AMI).
  • Data Provenance: Not explicitly stated but inferred to be from a clinical setting where samples for patients suspected of AMI were collected and compared with the predicate device. The samples were "EDTA whole blood samples obtained for each of these subjects." The study was likely prospective to obtain samples for direct comparison.
• Precision Study (duplicate testing):
  • Test Set Size: 179 subjects (77 normal individuals, 102 patients suspected of AMI).
  • Data Provenance: Samples were "selected randomly from those obtained during the Method Comparison Study." These samples were stored refrigerated for up to five days between analyses. This suggests retrospective analysis of samples collected during the method comparison, or a subset of freshly collected samples used specifically for this precision arm.
• Expected Values (Normal Range Study):
  • Test Set Size: 196 healthy individuals.
  • Data Provenance: Not explicitly stated, but "Whole blood samples from 196 healthy individuals" implies prospective collection from a healthy population.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no experts used to establish ground truth in the traditional sense. The device's performance was evaluated by comparing its quantitative myoglobin measurements to those obtained from an already marketed, legally predicate device (Beckman ACCESS Myoglobin Assay). The "ground truth" here is the measurement provided by the predicate device at the time of the study rather than a consensus of human experts interpreting diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set

No adjudication method was used, as this was a quantitative measurement comparison study against a predicate device. The comparison involved direct numerical measurements, not subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. It does not involve human readers interpreting cases with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance studies. The RAMP Myoglobin Assay, when used with the RAMP Reader, directly generates a quantitative myoglobin result. The performance data (precision, linearity, analytical sensitivity, and method comparison) evaluate the device's ability to produce accurate and reproducible measurements independently. Human input is limited to sample collection, loading, and reading the final numerical result from the RAMP Reader.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the method comparison studies was the quantitative myoglobin concentration determined by the predicate device, the Beckman ACCESS Myoglobin Assay. For analytical performance, the "ground truth" was established by known concentrations of myoglobin antigen (e.g., for linearity and analytical sensitivity).

8. The Sample Size for the Training Set

The document does not provide details about a specific "training set" for the RAMP™ Myoglobin Assay in the context of machine learning or AI models. This device is an immunochromatographic assay; its "training" or calibration would typically involve laboratory procedures to establish standard curves and internal controls during manufacturing and quality control, rather than a data-driven training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" and its "ground truth" in the AI sense does not apply directly to this particular device. Calibration and quality control for an immunoassay involve:

• Known Calibrators: Using substances with precisely known concentrations of myoglobin to establish a standard curve for the RAMP Reader to accurately convert fluorescence signals into myoglobin concentrations.
• Controls: Running samples with known myoglobin concentrations (quality controls) to ensure the assay is performing within established limits over time.

Ask a specific question about this device