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Immunoassay for the in vitro quantitative determination of N terminal pro Brain natriuretic peptide in human serum and plasma. This assay is used as an aid in the diagnosis of individuals suspected of having heart failure. The test is further indicated for the risk stratification of patients with acute coronary syndrome and 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 cobas e immunoassay analyzers.

Elecsys proBNP II (updated assay) is a second-generation assay by Roche Diagnostics for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human serum and plasma with increased biotin tolerance. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The cobas e family of analyzers employs the electrochemiluminescence immunoassay "ECLIA" technology. The assays are an 18-minute (Elecsys proBNP II) and 9 minute (Elecsys proBNP II STAT) application following a sandwich principle using two monoclonal antibodies which are specifically directed against NT-proBNP.

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

The document describes the analytical performance studies conducted for the Elecsys proBNP II and Elecsys proBNP II STAT assays, which are in vitro diagnostic devices. These assays are intended for the quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human serum and plasma, aiding in the diagnosis of heart failure, risk stratification, and assessment of cardiovascular event risk. The assays have been modified to include increased biotin tolerance.

The studies aim to demonstrate that the updated assays meet predetermined acceptance criteria for various analytical parameters, ensuring their safety and effectiveness and substantial equivalence to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" alongside "reported device performance" in a single, dedicated table for all parameters. However, the "Conclusion" sections for each analytical study implicitly state whether the acceptance criteria were met. Based on the provided text, a table can be constructed as follows:

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:

  • Precision (Repeatability & Intermediate): 8 human serum samples and 2 controls (n=10 total) for each assay, measured in 84 determinations over 21 operating days. The exact number of individual patient samples contained within the "8 human serum samples" is not specified but appears to be 8 distinct pools/matrices.
  • Precision (Inter-Instrument): 8 native human serum sample pools and 2 quality control levels (n=10 total) for each assay, with 75 determinations per sample/QC level (due to 5 days, 3 laboratories, 25 determinations/site, 5x5=25, 3 sites x 25 = 75 total reported).
  • Analytical Sensitivity (LoB): 60 determinations of an analyte-free sample.
  • Analytical Sensitivity (LoD): 5 low-level human serum samples, with 60 determinations per reagent lot.
  • Analytical Sensitivity (LoQ): 9 native, unaltered serum samples for Elecsys proBNP II and 10 native, unaltered serum samples for Elecsys proBNP II STAT, each tested with 25 measured values.
  • Linearity/Assay Reportable Range: One high analyte human, native serum sample diluted to 11 concentrations.
  • Endogenous Interference (Bilirubin, Hemoglobin, Lipemia, Biotin, Rheumatoid Factor, Albumin): Three different analyte concentration levels (low, medium, high) in human native serum samples. Specific number of samples at each level not explicitly stated but implied to be several.
  • Cross-Reactivity: Two human native serum samples (low and high analyte levels) spiked with potential cross-reactants.
  • Exogenous Interference (Drugs): Two human native serum samples (low and high analyte concentrations).
  • Matrix Comparisons: Single donor samples drawn into Serum (reference), Li-Heparin (98 pairs), and K2-EDTA plasma (111 pairs).
  • Method Comparison: 1928 subjects for Elecsys proBNP II STAT and 1940 subjects for Elecsys proBNP II.

• Data Provenance: The document generally refers to "human serum samples" and "native human serum samples" without specifying the country of origin. The studies are described as internal (e.g., "one internal site" for precision). There is no explicit mention of the data being retrospective or prospective, but the nature of in vitro diagnostic device performance studies (analytical validation) typically involves prospective testing of samples under controlled laboratory conditions, simulating diagnostic use.

3. Number of Experts and Qualifications for Ground Truth

The document does not describe the use of human experts to establish "ground truth" for the test set in the context of diagnostic interpretation (e.g., radiologists, cardiologists). This document details the analytical performance of an in vitro diagnostic assay, not an AI/imaging diagnostic device that requires expert adjudication of images. The "ground truth" in this context refers to the true analytical concentration of NT-proBNP in the samples, established through well-defined laboratory methodologies and traceable standards, or comparison to a previously cleared predicate device.

4. Adjudication Method for the Test Set

Not applicable. As this is an analytical validation of an in vitro diagnostic assay, there is no "adjudication method" in the sense of multiple human readers or experts resolving discrepancies in diagnostic interpretation. The methods involve quantitative analytical measurements of biochemical markers.

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

Not applicable. This is not an imaging or AI-assisted diagnostic device that would typically undergo an MRMC study. The study focuses on the analytical performance of a laboratory immunoassay.

6. Standalone (Algorithm Only) Performance

Not applicable in the typical sense for medical imaging AI. The "algorithm" here is the chemical reaction and measurement process of the immunoassay itself. The analytical performance metrics (precision, sensitivity, linearity, interference, matrix comparison) are effectively the "standalone performance" of the device. The method comparison study directly compares the performance of the updated device against its predicate (older version) without human intervention in the result generation.

7. Type of Ground Truth Used

The ground truth used for these analytical studies is primarily measured analytical concentration, established through:

• Reference materials: Calibrators and controls with known concentrations.
• Spiking experiments: Adding known amounts of analyte or interfering substances to samples.
• Dilutions: Creating samples with predictable concentrations.
• Comparison to predicate device: The method comparison studies compare the new device's results against the results from the previously cleared Elecsys proBNP II and Elecsys proBNP II STAT (older versions) as the reference.
• Consensus laboratory methods/standards: Studies like LoB, LoD, LoQ, and precision follow CLSI (Clinical and Laboratory Standards Institute) guidelines, which are established consensus standards for analytical validation.

There is no mention of pathology, clinical outcomes data, or expert consensus interpretation of results as a primary ground truth in this analytical performance section.

8. Sample Size for the Training Set

Not applicable. This document describes the analytical validation of laboratory assays, not a machine learning model that requires a "training set" in the same sense. The assay works based on established biochemical principles (electrochemiluminescence immunoassay, ECLIA, utilizing specific antibodies) and wet-lab procedures, not on learned patterns from a large dataset. Reagent formulation and process optimization might involve internal development data, but it's not a "training set" in the AI/ML context.

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

Not applicable, as there is no "training set" for an AI/ML model in this context. The "ground truth" for the development of the assay itself would be based on fundamental analytical chemistry principles, extensive laboratory testing, control materials, and established reference methods for quantifying NT-proBNP.

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Elecsys Troponin I Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and MODULAR Analytics E170 immunoassay analyzers.

Elecsys Troponin I STAT Immunoassay: Immunoassay for the in vitro quantitative determination of cardiac troponin I in human serum and plasma. The Elecsys Troponin I STAT assay is intended to aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys analyzers.

Elecsys PreciControl Troponin is used for quality control of the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays on the Elecsys and MODULAR Analytics E170 Analyzers.

The Elecsys Troponin I CalSet is used for calibrating the quantitative Elecsys Troponin I assay on the Elecsys and MODULAR Analytics E170 analyzers.

The Elecsys Troponin I STAT CalSet is used for calibrating the quantitative Elecsys Troponin I STAT assay on the Elecsys analyzers.

1.) The Elecsys Troponin I immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.

2.) The Elecsys Troponin I STAT immunoassay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.

3.) The Elecsys PreciControl Troponin is a lyophilized product consisting of human serum with added Troponin T and Troponin I in two concentration ranges. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

4.) The Elecsys Troponin I CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

5.) The Elecsys Troponin I STAT CalSet is a lyophilized product consisting of human serum with added Troponin I in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Note: The reagent, calibrator, and quality control materials are all packaged separately.

The provided 510(k) summary for K082699 describes the Elecsys Troponin I and Elecsys Troponin I STAT immunoassays, along with their associated control and calibrator products. The submission aims to demonstrate substantial equivalence to predicate devices. However, it's important to note that this document does not describe acceptance criteria in the traditional sense of performance targets that trigger a pass/fail for a device. Instead, it presents performance data for the device and compares various features to a predicate device to establish substantial equivalence.

Here's an analysis of the provided information, framed to address your questions where applicable, and highlighting what's not explicitly stated in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document doesn't provide explicit "acceptance criteria" for the Elecsys Troponin I assays. It presents performance characteristics and compares them to a predicate device (Beckman Coulter Access AccuTnI Immunoassay, K021814) to establish substantial equivalence. The "reported device performance" columns below are the actual measured values from the studies. The "Acceptance Criteria" cells are left blank as they were not specified in the document.

Elecsys Troponin I STAT Assay (Main Assay)

Elecsys Troponin I Assay (18 Minute) - (Similar to STAT, but with slight differences in precision and method comparison)

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

• Sample Size for Test Set:
  • Method Comparison (Elecsys Troponin I STAT Assay): N = 114
  • Method Comparison (Elecsys Troponin I Assay): N = 115
  • Precision Studies: Not explicitly stated as a single "test set" sample size. The precision studies involved multiple samples at different concentration levels, tested repeatedly (within-run, between-run, between-day) across different sites (US Site 1, US Site 2, EU Site 1). The number of replicates for each sample at each site is not detailed.
• Data Provenance: The document explicitly mentions "US Site 1", "US Site 2", and "EU Site 1" for precision studies, indicating data from both the United States and Europe. The "Method Comparison" studies do not explicitly state the country of origin but are generally part of clinical trials or validation studies related to regulatory submissions. The studies are assumed to be prospective or generated specifically for the submission, but this is not explicitly stated as retrospective or prospective for all data.

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

This information is not provided in the 510(k) summary. These are in-vitro diagnostic immunoassays for quantitative determination of a biomarker; the "ground truth" for method comparison is typically the result from a well-established predicate device or a reference method, not established by human experts in the way it would be for an imaging AI device.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for this type of IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for quantifying a biomarker in a lab assay. The "gold standard" for comparison is often the predicate device itself or a recognized reference method.

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

This is not applicable as the device is an in-vitro diagnostic immunoassay, not an AI or imaging device that involves human readers.

6. Standalone Performance

Yes, the performance data presented (precision, linearity, method comparison, limits of detection/quantitation, interference) represents the standalone performance of the Elecsys Troponin I assays themselves. The comparison to the predicate device validates its performance relative to an already marketed and accepted device. Human interaction is limited to operating the analyzer and performing necessary calibration/quality control, not interpreting the results in a "human-in-the-loop" AI context.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Elecsys Troponin I immunoassays is established by:

• Comparison to a Predicate Device: The method comparison studies directly compare the results of the Elecsys assays to the Beckman Coulter Access AccuTnI assay (K021814). This predicate device serves as the de-facto "ground truth" for demonstrating substantial equivalence.
• Analytical Standards: The determination of Limits of Blank (LoB), Limits of Detection (LoD), Limits of Quantitation (LoQ), and precision are based on established statistical methods and analytical standards in laboratory medicine, often using spiked samples or reference materials.
• Clinical Significance: The "expected values" and cut-off levels are derived from population studies and clinical guidelines related to troponin levels in the diagnosis of myocardial infarction.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI models. For an in-vitro diagnostic immunoassay like the Elecsys Troponin I, the development process involves extensive analytical validation studies, but these are not typically referred to as "training sets" in the AI sense. The document does not specify a "training set" size. The samples used for initial development, optimization, and early validation are not detailed here.

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

As discussed in point 8, the concept of a "training set" doesn't directly apply here in the AI context. For the analytical validation studies (e.g., precision, linearity), the "ground truth" (or target values) for samples would be established through:

• Gravimetric or Volumetric Preparations: For spiked samples, known concentrations of troponin I would be added to a matrix.
• Reference Methods: Comparison to established, highly accurate reference methods, if available, for specific analytical parameters.
• Predicate Device Results: For method comparison, the results from the predicate device are considered the comparative "truth."

The document does not detail how the "ground truth" for these various analytical studies was established beyond mentioning standardization against the predicate device.

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