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The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

The AxSYM Troponin-1 ADV reagent is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System.

The provided text describes a 510(k) summary for the Abbott AxSYM® Troponin-I ADV assay. This is an in vitro diagnostic (IVD) device, and the evaluation for such devices often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on clinical outcomes or improved human reader performance in the same way a software-as-a-medical-device (SaMD) might be evaluated.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence between the Abbott AxSYM® Troponin-I ADV assay and the Beckman Coulter Access® AccuTnI assay. The acceptance criteria for analytical performance typically involve correlation and agreement statistics between the new device and the predicate.

Note on Acceptance Criteria: The specific numerical acceptance criteria (e.g., minimum 'r' value, acceptable range for slope and intercept) are not explicitly stated in this summary. However, given the FDA's clearance, it can be inferred that the reported performance values met the internal and FDA's requirements for demonstrating substantial equivalence to the predicate device.

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

• Sample Size:
  • All Specimens: n = 546
  • ADV Dynamic Range: n = 531
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is clinical sample data used for method comparison.

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

For IVD devices like this, particularly when demonstrating substantial equivalence via method comparison, the "ground truth" is typically the result obtained from the predicate device (the Beckman Coulter Access® AccuTnI assay). There isn't an "expert" panel establishing a consensus ground truth in the way one might for image-based diagnostic AI. The predicate device itself serves as the reference standard.

4. Adjudication Method

Not applicable for this type of IVD device evaluation. Adjudication methods (like 2+1 or 3+1) are common in studies where multiple human readers are interpreting imaging or clinical data, and a consensus ground truth needs to be established. Here, the comparison is directly between two analytical assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is not relevant for an IVD assay like the Abbott AxSYM® Troponin-I ADV.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Yes, in a sense, a standalone performance study was done. The performance metrics (correlation, slope, intercept) compare the Abbott AxSYM® Troponin-I ADV assay (the "algorithm" in this context) directly against the predicate device without human intervention influencing the assay's output. The device is intended for quantitative determination, and its output is a numerical value, not an interpretation requiring a human in the loop for diagnosis.

7. The Type of Ground Truth Used

The ground truth or reference standard was the performance of the legally marketed predicate device: the Beckman™ Coulter Access® AccuTnI assay. The study aimed to show that the new device's quantitative measurements of cardiac troponin-I were highly correlated and in agreement with those obtained from the predicate device.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. For traditional IVD assays, there isn't typically a distinct 'training set' in the same way there is for AI/ML models. The development and optimization of the assay reagents and parameters would have occurred prior to this substantial equivalence study, but the specific sample sizes for those developmental phases are not provided. The numbers cited (546 and 531) refer to the test set used for the method comparison study to demonstrate substantial equivalence.

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

As noted above, the concept of a "training set" with established ground truth, as understood in AI/ML, doesn't directly apply here. The Abbott AxSYM® Troponin-I ADV is a microparticle enzyme immunoassay, not an AI/ML algorithm that learns from data. Its "ground truth" for development would involve analytical accuracy, precision, linearity, and other performance characteristics established against known standards or reference materials during product development.

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The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnl) in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI)

The AxSYM Troponin-I ADV Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of cardiac troponin-I in human serum or plasma.

The AxSYM Troponin-I ADV Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM System (reagents, calibrators, and instrument) when used for the quantitative measurement of cardiac troponin-l in human serum or plasma.

The AxSYM Troponin-I ADV assay is a Microparticle Enzyme Immunassay for the quantitative determination of cardiac troponin-I in human serum or plasma. The AxSYM Troponin-I ADV assay is calibrated with AxSYM Troponin-I ADV Standard Calibrators. AxSYM Troponin-I ADV Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

Acceptance Criteria and Study for Abbott AxSYM® Troponin-I ADV Assay

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Abbott AxSYM® Troponin-I ADV assay to the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the substantial equivalence claim relies on a correlation analysis between the new device and a predicate device. The acceptance criteria are implicitly defined by the demonstration of a strong correlation (high R-value) and a slope close to 1, with an intercept close to 0, which would indicate similar measurements between the two assays. While explicit numerical thresholds for acceptance (e.g., minimum R, range for slope and intercept) are not provided, the reported performance is presented to demonstrate this similarity.

Note: The reported slope of 1.47 indicates a potential systematic difference where the Abbott AxSYM® device may be reading higher values than the predicate device. However, the FDA has deemed this acceptable for substantial equivalence in this context.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • All Specimens: 546
  • ADV Dynamic Range: 531
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in-vitro diagnostic, it is generally expected that studies are conducted with specimens from human sources, and frequently these are done through clinical studies in a prospective or mixed fashion, but this specific detail is not provided.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study is a comparative effectiveness study between two diagnostic devices, not a study evaluating human expert performance against a "true" ground truth in the traditional sense (e.g., identifying disease from an image). The "ground truth" for the comparison is the measurement provided by the legally marketed predicate device, the Beckman Coulter™ Access® AccuTnI assay.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is a direct comparison between two quantitative assays. There is no human adjudication process involved in establishing the "ground truth" (i.e., the predicate device's measurement).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described. This submission pertains to an in-vitro diagnostic device (an assay), not an imaging device or algorithm designed to be interpreted by human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. Standalone Performance Study

Yes, a standalone performance study was done for the Abbott AxSYM® Troponin-I ADV assay by comparing its measurements directly against an established predicate device. The results of this comparison (correlation, slope, intercept) demonstrate the standalone performance of the algorithm (assay method). It measures quantitative determination of cardiac troponin-I in human serum or plasma without human intervention in the measurement process itself, beyond sample handling.

7. Type of Ground Truth Used

The "ground truth" in this context is the quantitative measurement provided by the Beckman Coulter™ Access® AccuTnI assay, which is explicitly stated as the predicate device. This is a form of comparative ground truth against an established, legally marketed device.

8. Sample Size for the Training Set

Not applicable. This 510(k) summary describes a device comparison study for market clearance, not an AI or machine learning model development where a training set would be explicitly used to develop the algorithm itself. The AxSYM® Troponin-I ADV assay is a Microparticle Enzyme Immunoassay (MEIA), a well-established biochemical assay technology. The reported "n" values (546 and 531) refer to the number of specimens used in the comparability study, which serves as the "test set" for demonstrating substantial equivalence.

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

Not applicable, as there is no training set in the context of an AI/ML algorithm being developed. For the development of the assay itself (e.g., establishing its reagents, calibration, and measurement principles), extensive internal R&D and validation would have occurred. However, the 510(k) submission focuses on the clinical performance comparison against a predicate for regulatory clearance.

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Abbott AxSYM® Troponin-I is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the Abbott AxSYM System. Measurements obtained by this device are used to assist in the diagnosis of acute myocardial infarction (AMI).

AxSYM Troponin-I is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma. AxSYM Troponin-I is calibrated with Abbott Troponin-I Calibrators. Abbott Troponin-I Controls are assayed for the verification of the accuracy and precision of the AxSYM System. Both assays are automated, in vitro immunoassays that use antibodies specific for the cardiac isotype of troponin-I. The fluorescent signal measured by both assays is directly proportional to the concentration of cardiac troponin-I in the sample.

Acceptance Criteria and Study for Abbott AxSYM® Troponin-I

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the Abbott AxSYM® Troponin-I assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AxSYM Troponin-I assay were implicitly defined by demonstrating substantial equivalence to a predicate device and achieving clinically acceptable sensitivity and specificity for the diagnosis of Acute Myocardial Infarction (AMI). While specific quantitative acceptance criteria for sensitivity and specificity were not explicitly stated as "acceptance criteria" in the provided text, the reported performance was considered sufficient for regulatory approval.

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

• Test Set Sample Size:
  • Clinical Study: 246 patients, representing 689 observations (serial samples).
  • Method Comparison: 158 specimens for the Passing-Bablok linear regression analysis.
• Data Provenance: The document does not explicitly state the country of origin. The study was described as a "multi-center clinical study," which generally implies prospective data collection, especially given the serial sampling to rule in/rule out AMI. The method comparison data would also be considered prospective.

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

• The ground truth for AMI diagnosis in the clinical study was based on the World Health Organization (WHO) criteria for AMI. The document does not specify the number or qualifications of individual experts who applied these criteria to establish the ground truth for each patient. This suggests that the ground truth was established by clinical teams at the participating centers following established medical guidelines, rather than by a panel of independent, reviewing experts for the purpose of the study.

4. Adjudication Method for the Test Set

• The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth regarding AMI diagnosis. As mentioned above, the diagnosis was based on WHO criteria, implying a standard clinical diagnostic process.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic (IVD) assay (a laboratory test) that provides a quantitative result. Its effectiveness is assessed by its analytical performance and clinical accuracy in diagnosing a condition, not by human reader interpretation or improved human reader performance with AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The clinical sensitivity (93.9%) and specificity (93.4%) were determined for the AxSYM Troponin-I assay alone, using a diagnostic cutoff of 2.0 ng/mL, against the clinical diagnosis of AMI based on WHO criteria. This represents the algorithm's (assay's) performance without human interpretation or intervention in the diagnostic output.

7. Type of Ground Truth Used

• Clinical Diagnosis / Outcomes Data (for sensitivity/specificity): The primary ground truth for the clinical study was the World Health Organization (WHO) criteria for AMI. This is a well-established clinical definition for myocardial infarction.
• Predicate Device Measurement (for correlation): For the method comparison, the Dade® Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay served as the reference for comparison, indicating that its measurements were considered the "ground truth" for evaluating analytical agreement.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning or AI models. The AxSYM Troponin-I is an immunoassay, which does not typically involve traditional machine learning training sets in the same way an AI algorithm for image analysis would. Development and calibration would involve various internal validation samples, but these are not usually referred to as a "training set" in this context.

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

• As noted above, the concept of a training set with established ground truth in the AI/ML sense does not directly apply here. For standard immunoassay development, the "ground truth" for calibrator and control materials is established through rigorous analytical methods, often involving reference methods or gravimetric preparation of known analyte concentrations. The accuracy and precision of these materials are critical for the assay's performance.

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