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For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.

For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.

The Vitros Troponin I assay is performed using the Vitros Troponin I Reagent Pack and Vitros Immunodiagnostic Products Troponin I Calibrators on the Vitros ECi Immunodiagnostic System with Intellicheck ™ . An immunometric technique is used. Cardiac Troponin I present in the sample reacts simultaneously with a biotinylated antibody (mouse monoclonal anti-cTnI) and a horseradish peroxidase (HRP)-labeled antibody conjugate (affinity purified goat polyclonal anti-cTnI). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent (a substituted acetanilide) is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the Vitros ECi System. The amount of HRP conjugate bound is directly proportional to the concentration of cTnI present in the sample.

The provided text details a 510(k) submission for the VITROS Immunodiagnostic Products Troponin I Reagent Pack and VITROS Immunodiagnostic Products Troponin I Calibrators. This document primarily focuses on demonstrating substantial equivalence to a predicate device and presenting performance data related to interference and precision rather than explicitly outlining "acceptance criteria" for a novel device's performance against clinical endpoints.

However, based on the provided information, we can infer some performance expectations and how they are addressed:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Since this is a 510(k) submission for an in-vitro diagnostic device, the "acceptance criteria" are implicitly tied to demonstrating performance that is equivalent to a legally marketed predicate device and within clinically acceptable ranges for intended use. The document provides data on precision at relevant Troponin I concentrations and potential interference.

The study details that evaluate these performance characteristics are described below:

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

• Precision Study:

  • Sample Size: Ten patient sample pools.
  • Testing Protocol: Assayed in singleton once per day on 11 different days over a 28-day period using a single reagent lot.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "patient sample pools," suggesting human biological samples. The study design (multiple days, single reagent lot) is typical for prospective precision studies. Retrospective vs. Prospective is not explicitly mentioned but implies prospective testing.

• Hemoglobin Interference Study:

  • Sample Size: Not explicitly stated, but measurements were performed at two different "troponin levels" (0.026 ng/mL and approximately 0.3 ng/mL) with varying hemoglobin concentrations.
  • Testing Protocol: Replicate determinations were performed using one or two different lots of reagent.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The nature implies laboratory testing rather than real-world patient data (prospective testing for interference).

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

Not applicable. This is an in-vitro diagnostic (IVD) assay for measuring a biomarker, not an imaging device or a device requiring expert interpretation of results to establish a "ground truth" for the device's output. The "ground truth" for the precision and interference studies would be the known concentration of Troponin I in the spiked samples or the analytical value against which bias is calculated.

4. Adjudication Method for the Test Set

Not applicable. This is an IVD assay, and the outcome is a quantitative measurement, not a subjective interpretation 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?

Not applicable. This is an IVD assay and does not involve "human readers" or "AI assistance" in the context of interpretation that would necessitate an MRMC study.

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

This is an IVD device, which by its nature, operates in a "standalone" fashion by performing the quantitative measurement. The results are then interpreted by clinicians. The precision and interference studies demonstrate this standalone performance.

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

The "ground truth" for the performance studies is based on:

• Known (nominal) concentrations: For the precision and interference studies, the analyte concentrations (Troponin I and hemoglobin) in the samples or spiked samples serve as the reference or nominal "ground truth" against which the device's measurements, variability, and bias are evaluated.
• Analytical methods/reference materials: The accuracy of these known concentrations would be established using validated analytical methods and potentially reference materials, though the specific methods for establishing the initial sample concentrations are not detailed in this summary.

8. The Sample Size for the Training Set

Not applicable. This device is a biochemical immunoassay, not a machine learning or AI-driven device that requires a "training set" in the computational sense. Its performance is based on chemical reactions and optical detection.

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

Not applicable, as there is no training set for this type of device.

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For the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction.

For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human heparin plasma.

The Vitros Troponin I assay is performed using the Vitros Troponin I Reagent Pack and Vitros Immunodiagnostic Products Troponin I Calibrators on the Vitros ECi Immunodiagnostic System with Intellicheck ™ . An immunometric technique is used. Cardiac Troponin I present in the sample reacts simultaneously with a biotinylated antibody (mouse monoclonal anti-cTnI) and a horseradish peroxidase (HRP)-labeled antibody conjugate (affinity purified goat polyclonal anti-cTnI). The antigen-antibody complex is captured by streptavidin on the wells. Unbound materials are removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent (a substituted acetanilide) is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The light signals are read by the Vitros ECi System. The amount of HRP conjugate bound is directly proportional to the concentration of cTnI present in the sample.

This document describes the acceptance criteria and study proving the VITROS Immunodiagnostic Products Troponin I Reagent Pack and Calibrators meet the criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the establishment of diagnostic thresholds.

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

• Correlation Data Test Set:

  • Sample Size: 198 samples
  • Data Provenance: "panel of patient samples from a variety of clinical categories." (Retrospective, origin not specified beyond "patient samples")

• Upper Reference Limit (URL) Test Set:

  • Sample Size: 798 fresh heparin plasma samples
  • Data Provenance: "normal blood donors between the ages of 18-89 (61.3% male donors and 38.7% female donors collected across six sites)." (Prospective or retrospective, origin not specified beyond "six sites"; implies multi-center U.S. data likely given FDA submission)

• AMI Cut-off Test Set:

  • Sample Size: 458 chest pain patients, where 78 were diagnosed with AMI.
  • Data Provenance: "chest pain patients" (Retrospective clinical data, origin not specified beyond "patients")

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

The document does not specify the number or qualifications of experts used to establish ground truth for any of the test sets.

• For the correlation data, the ground truth is implicitly the values obtained from the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method (the predicate device).
• For the upper reference limit, "normal blood donors" classification would likely be based on standard health screenings, not expert consensus on troponin levels.
• For the AMI cut-off, the "diagnosis of AMI" for the 78 patients would be the ground truth. This diagnosis is typically established by clinicians based on a combination of patient symptoms, ECG changes, and cardiac biomarker levels (including troponin, but not exclusively). The specific method or expert involvement in confirming these AMI diagnoses is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for establishing ground truth for any of the test sets. Ground truth for the correlation data is the predicate device's measurement. Ground truth for normal donors is their clinical classification as healthy. Ground truth for AMI patients is their clinical diagnosis, but the process of this diagnosis (e.g., whether it involved multiple blinded reviewers) is not detailed.

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. The device is an in vitro diagnostic (IVD) assay measuring a biomarker (Troponin I). It is not an AI-assisted diagnostic imaging device or an algorithmic tool intended to directly assist human readers in interpreting complex visual or clinical data in the way an MRMC study would typically evaluate. The assay directly provides a quantitative result.

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

This section is applicable, and the studies outlined are standalone performance evaluations of the device. The device itself (the VITROS Troponin I assay) is an automated system that provides a quantitative measurement. The reported performance metrics (correlation coefficient, URL, AMI cut-off with sensitivity/specificity) are derived from the device's output without human intervention in the measurement process after sample introduction. The human "in-the-loop" would be the clinician interpreting the result, but the performance data presented is the "algorithm only" (assay only) output.

7. The Type of Ground Truth Used

• Correlation Data: The ground truth was the measurements obtained from the predicate device (DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method).
• Upper Reference Limit: The ground truth was the clinical classification of "normal blood donors."
• AMI Cut-off: The ground truth was the clinical diagnosis of "AMI" for 78 patients out of a total of 458 chest pain patients. This represents a form of outcomes data or clinical diagnosis.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of machine learning. For IVD devices, method validation studies typically involve defining parameters (like the URL and cut-off points) based on observed performance in clinical populations rather than explicit "training" in the AI sense.

• The upper reference limit (0.08 ng/mL) was established using a panel of 798 fresh heparin plasma samples from normal blood donors. This can be considered the "dataset used to define a normal range."
• The AMI cut-off (0.4 ng/ml) was determined using 458 chest pain patients (78 with AMI) via Receiver Operator Characteristic (ROC) curve analysis. This can be considered the "dataset used to optimize a diagnostic threshold."

These datasets serve a similar purpose to a training set in that they are used to establish and optimize operating parameters for the device's interpretation.

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

• For the Upper Reference Limit: The ground truth for the 798 samples was their status as "normal blood donors" (presumably healthy individuals without cardiac disease) aged 18-89. This classification would typically be based on standard donor screening procedures and health questionnaires.
• For the AMI Cut-off: The ground truth for the 458 chest pain patients was their clinical diagnosis, specifically whether they were "diagnosed with AMI." This diagnosis would have been made by medical professionals based on clinical presentation, ECG findings, and other relevant diagnostic information available at the time of the patient's care.

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For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction.

For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894). 2. 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). 3. 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). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text details the 510(k) summary for the VITROS Immunodiagnostic Products Troponin I Reagent Pack and Calibrators. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a full study report with detailed acceptance criteria and performance against those criteria as would be found in a clinical trial.

Based on the provided information, a complete table of acceptance criteria and reported device performance with numerical metrics cannot be fully constructed for independent standalone performance (i.e. algorithm only without human-in-the loop performance). However, I can extract the information related to the comparison study.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

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

• Sample Size: The document states that the relationship between the VITROS Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I assay was determined from a "panel of patient samples from a variety of clinical categories." However, the specific number of samples (sample size) used for this correlation study is not provided.
• Data Provenance: The text does not explicitly state the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the use of "patient samples" for a correlation study often implies retrospective analysis of collected samples.

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

• Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for cardiac markers), the "ground truth" is typically established by the quantitative measurement of Troponin I itself, often through the predicate device or a reference method. It does not involve human expert interpretation (e.g., radiologists assessing images). Therefore, there is no mention of experts establishing a ground truth for a test set in the context of human interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: As the "ground truth" for this device is based on quantitative chemical measurement, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant or discussed. The primary "adjudication" is the chemical measurement itself, and the comparison is statistical.

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:

• Not Applicable: This device is an in vitro diagnostic assay (a laboratory test kit), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or an 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:

• Yes, this is an inherently standalone device. The VITROS Immunodiagnostic System, using the VITROS Troponin I assay, performs the quantitative measurement of Troponin I. This is an automated process without human intervention in the actual measurement or interpretation of the raw signal to produce the Troponin I concentration. The device itself provides the final quantitative result. The study of substantial equivalence directly assessed the performance of this device (algorithm/system) against the predicate device.

7. The type of ground truth used:

• The ground truth for demonstrating equivalence was the quantitative measurement results obtained from the predicate device (DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method). The VITROS Troponin I assay's measurements were compared against these predicate measurements.

8. The Sample Size for the Training Set:

• Not Provided / Not Applicable (in the traditional machine learning sense): As this is an immunoassay device, the concept of a "training set" in the context of machine learning (where an algorithm learns from data) does not directly apply. The device's performance characteristics (calibration range, precision, analytical sensitivity, specificity) are established through analytical validation studies during its development, not by training an algorithm on a dataset in the way an AI would be. The document mentions "currently commercially available reagents" and patient samples for the correlation study, which serves as a validation set.

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

• Not Applicable (as per point 8): Since there isn't a "training set" in the machine learning sense, the establishment of its ground truth is not applicable. The assay's analytical characteristics are determined through standard laboratory procedures and reference materials.

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