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Immunoassay for the in vitro quantitative determination of N-terminal pro-brain natriuretic peptide in human serum and plasma. The Elecsys proBNP II STAT assay is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure. The test may also serve as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

The proBNP II Assay is a sandwich immunoassay with two antibodies directed towards epitopes within the N-terminal portion of the proBNP molecule. The capture antibody is biotinylated to react with streptavidin-coated microparticles. The signal antibody is tagged with ruthenium. Both antibodies are monoclonal. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.

Acceptance Criteria and Device Performance Study for Elecsys proBNP II STAT Immunoassay

This document describes the acceptance criteria and the study that demonstrates the Elecsys proBNP II STAT Immunoassay meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Elecsys proBNP II STAT Immunoassay are primarily demonstrated by showing substantial equivalence to the predicate device, the Elecsys proBNP II Assay (K072437), with key performance characteristics either matching or falling within acceptable ranges. The primary difference is the faster "STAT" application time and limited instrument platform.

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

• Test Set Sample Size: n = 120 patient samples were used for the method comparison study.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, based on the context of a 510(k) submission seeking equivalence to a previously approved device, these data are typically generated in controlled laboratory settings (often prospective testing of patient samples) by the manufacturer or authorized agents.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. This device is an immunoassay measuring a biomarker (NT-proBNP) quantitatively. The "ground truth" for the test set values is considered the measurements obtained by the predicate device itself, not an expert consensus on a diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this is a quantitative immunoassay comparison, there is no "adjudication" in the sense of independent expert review of cases. The comparison is statistical, comparing the results of the new device against the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks where human readers' performance is being evaluated, possibly with AI assistance. For a quantitative immunoassay, the performance is assessed by comparing its measurements to a reference method (the predicate device) and evaluating its analytical characteristics (precision, sensitivity, range).
• Effect Size of Human Readers with/without AI assistance: Not applicable.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was done for the Elecsys proBNP II STAT Assay. The "method comparison" section directly shows the performance of the new device alone against the predicate device on patient samples (n=120) and demonstrates its analytical performance characteristics (precision, analytical sensitivity, measuring range, hook effect, limitations) independently. The core of this 510(k) summary is to demonstrate that the device itself performs equivalently to the predicate to warrant a "substantially equivalent" classification.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the method comparison study was the measurements obtained from the existing, legally marketed predicate device (Elecsys proBNP II Assay, K072437). This is a common approach in 510(k) submissions for in vitro diagnostic (IVD) devices seeking substantial equivalence where a well-established predicate device exists. The predicate device's measured values are treated as the reference standard for comparison.

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size in the context of typical machine learning models. This is an immunoassay, not an AI/ML-based device in the common understanding. The development and optimization of such assays typically involve iterative laboratory testing and refinement of reagents, protocols, and instrument parameters, which could be considered an internal "training" process, but not in the sense of a distinct, labeled dataset for algorithm training.

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

• Ground Truth for Training Set: Not applicable in the conventional sense of AI/ML training. The "ground truth" for developing and optimizing the assay itself would be based on established analytical chemistry principles, characterization of assay components (antibodies, calibrators), and performance against known reference materials or other validated laboratory methods. This iterative process leads to the final assay formulation and protocol, which is then formally validated using the test set described above against the predicate.

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The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure.

The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with a RAMP reader to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Mixed EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip. The red blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-NT-proBNP antibodies bind to NT-proBNP, if present in the sample. As the sample migrates along the strip. NT-proBNP bound particles are captured at the detection zone, and additional particles are captured at the internal standard zone.

The RAMP reader then measures the amount of fluorescence emitted by the complexes captured at the detection zone and at the internal standard zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

Here's a breakdown of the acceptance criteria and study information for the RAMP® NT-proBNP Assay, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds against which the device performance is measured. Instead, the document presents detailed performance characteristics (precision, linearity, limits, analytical specificity, interference) and then compares the clinical performance (method comparison, sensitivity/specificity, ROC analysis) against a predicate device (Roche Elecsys proBNP Assay) and using established cut-offs.

However, based on the conclusions and the comparative data, we can infer some desired performance characteristics.

Study Details

2. Sample sizes for the test set and data provenance

• Method Comparison Test Set (RAMP vs. Elecsys):
  • Total Patients Enrolled: 699
  • Samples analyzed within reportable range (34 ng/L to 22,000 ng/L): 580
  • HF Diagnosed: 274 (164 males, 110 females)
  • Non-HF Reference Group: 306 (124 males, 182 females)
  • Data Provenance: Not explicitly stated regarding country of origin, but implied to be from clinical sites where patients were enrolled. The use of "individual hospital criteria" suggests multiple sites. The study is prospective in nature, as samples were collected "for each of these subjects" and then analyzed by both devices.
• Clinical Sensitivity and Specificity Test Set:
  • Total Subjects: 858
  • Diagnosed with HF: 299 (using local hospital criteria)
  • Non-HF with potentially confounding co-morbidity: 189
  • Reference Individuals (healthy, no co-morbidities): 370 (includes an additional 159 subjects from an additional clinical site without concomitant testing in the Elecsys system).
  • Data Provenance: Implied to be from clinical sites. The collection of "data collected from 858 subjects" suggests a mix of retrospective and prospective, however the descriptions of "presenting population" and "enrolled" subjects points more towards a prospective data collection. The additional 159 subjects were "added from an additional clinical site".

3. Number of experts used to establish the ground truth for the test set and their qualifications

The ground truth for Heart Failure (HF) diagnosis was primarily established "based on individual hospital criteria" and "using local hospital criteria." This implies that the diagnosis was made by treating physicians at the respective clinical sites. The document does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1, none) for the clinical diagnosis of heart failure. The ground truth ("local hospital criteria") suggests that hospital-based clinical judgment was used.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a quantitative immunochromatographic test for measuring NT-proBNP levels, not an AI-assisted diagnostic imaging device or a decision support system for human readers. The comparison is between the RAMP device and a predicate laboratory device (Roche Elecsys proBNP Assay) and the device's performance metrics (sensitivity, specificity) in diagnosing HF.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance study was clearly done. The entire "Summary of Studies" section details the performance characteristics of the RAMP NT-proBNP Assay when used without human intervention in interpreting the raw data. The RAMP reader provides a quantitative result (ng/L) of NT-proBNP levels. The clinical efficacy (sensitivity, specificity) is calculated based on these quantitative results against a clinical diagnosis (ground truth), demonstrating the algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The primary ground truth used for heart failure diagnosis was clinical diagnosis based on individual hospital criteria. This would typically involve a combination of patient history, physical examination, imaging (e.g., echocardiogram), and other laboratory tests as judged by the treating clinicians. The document does not mention pathology or long-term outcomes data being used as the primary ground truth for the diagnostic studies.

8. The sample size for the training set

The document does not explicitly describe a separate "training set" for the RAMP NT-proBNP Assay algorithm in the context of machine learning. For chemical assays like this, the "training" (or development and optimization) of the assay itself is done during product development using various known concentrations and interfering substances. The performance characteristics studies (precision, linearity, LoD, LoQ, analytical specificity, interference) could be considered part of the internal validation/optimization process which might indirectly involve a "training set" of samples, but these are presented as characterization studies rather than specific training data for a machine learning model. The clinical evaluation samples (699 for method comparison, 858 for sensitivity/specificity) serve as the test sets for demonstrating performance.

9. How the ground truth for the training set was established

As there is no explicitly defined "training set" in the machine learning sense, the method for establishing its ground truth is not applicable/not provided. The ground truth for the performance characterization studies (e.g., linearity, LoD) would be established by preparing samples with known, precise concentrations of NT-proBNP (spiked blood or control material where the true concentration is known).

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For the in vitro quantitative determination of N-terminal proBrain natriuretic peptide in human serum and plasma.

Elecsys proBNP is used as an aid in the diagnosis of individuals suspected of having congestive heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and congestive heart failure.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010, Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers

A device for the measurement of human proBNP in serum or plasma.

Here's a breakdown of the acceptance criteria and study information for the Elecsys® proBNP Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the document presents a comparative analysis against a predicate device (Elecsys proBNP (K022516)) and another predicate for conceptual use (Triage BNP (K021317)). The "acceptance" is implied by demonstrating substantial equivalence to these legally marketed devices.

The table below summarizes the performance characteristics of the Elecsys proBNP (add'l indication) and compares them to the predicate devices. The "acceptance criteria" column reflects the performance of the primary predicate for the device.

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

The provided 510(k) summary does not contain specific details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mainly focuses on the performance characteristics and comparison to predicate devices, but the underlying study details are not present.

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. For an in vitro diagnostic device, "ground truth" for performance studies typically comes from reference methods, clinical diagnosis, or patient outcomes, rather than expert consensus on images or similar data.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Adjudication methods are more commonly described in studies where human interpretation of data is a variable (e.g., medical imaging studies).

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 is relevant for devices involving human interpretation, especially AI-assisted diagnostic tools. The Elecsys proBNP Immunoassay is a laboratory-based immunoassay, not an AI-powered image analysis or interpretation tool.

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

Yes, the performance characteristics presented (precision, hook effect, analytical sensitivity, measuring range, limitations) represent the standalone performance of the immunoassay itself, without human-in-the-loop performance impacting the measurement results. The device quantifies a biomarker directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance characteristics described:

• Precision and Analytical Sensitivity: Ground truth is established by well-defined analytical methods using control materials or spiked samples with known concentrations.
• Hook Effect: Established by testing samples with extremely high concentrations to determine if the assay accurately reports or produces a falsely low result.
• Limitations (Interference): Established by testing samples spiked with known interferents at various concentrations.

For the clinical indications for use (aid in diagnosis of CHF, risk stratification for ACS and CHF), the underlying ground truth would be established through clinical diagnosis, patient outcomes, and potentially other diagnostic tests in clinical trials (which are not detailed in this 510(k) summary).

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The Elecsys proBNP Immunoassay is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The assay is developed and validated through biochemical and analytical testing.

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

As noted above, this is not applicable for this type of device.

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