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The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum and plasma (EDTA), using the ACCESS® Immunoassay System.

The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum and plasma (EDTA), using the ACCESS® Immunoassay System.

The ACCESS® Troponin I assay is a chemiluminescent immunoassay designed for the quantitative determination of cardiac troponin I levels in human serum and plasma. The study aimed to establish the clinical performance characteristics of the device and demonstrate its substantial equivalence to a previously cleared troponin I assay (Baxter Stratus® Cardiac Troponin-I) and CK-MB, which was considered the "gold standard" biochemical marker at the time.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Clinical Performance Study: 289 subjects presenting to the emergency department with chest pain.
    • 45 subjects were ruled-in for Acute Myocardial Infarction (AMI).
  • Correlation with Stratus® (clinical): 201 patients.
  • Concordance with CK-MB (clinical): 208 subjects.
  • Specificity in Skeletal Muscle Injury: 58 patients.
  • Specificity in Renal Disease: 81 subjects.
  • Correlation with Stratus® (analytical): 189 samples.
• Data Provenance: The study was described as a "multi-site prospective study." The country of origin is not explicitly stated, but given the 510(k) submission to the FDA, it is highly probable the data was collected within the United States.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the clinical diagnosis of AMI (rule-in/rule-out). However, the "gold standard biochemical marker, CK-MB" was used as a comparative measure, suggesting that a combination of clinical assessment and established biochemical markers (like CK-MB) likely formed the basis for the ground truth determination rather than solely expert consensus on imaging or other modalities.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The diagnosis of AMI was established by following subjects serially (minimum of two serum samples) to "rule-in or rule-out AMI," implying a standard clinical diagnostic process was followed rather than a specific expert adjudication process for the test results themselves.

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

No, an MRMC comparative effectiveness study was not done. This study is for an in-vitro diagnostic (IVD) assay that measures a biomarker, not an imaging device or AI-assisted diagnostic tool that would typically involve human readers. Therefore, there is no effect size reported for human readers improving with or without AI assistance.

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

Yes, the primary clinical performance (sensitivity, specificity, concordance) was assessed for the ACCESS® Troponin I assay as a standalone device (i.e., algorithm only if you consider the "algorithm" to be the assay's chemical reaction and measurement process). There is no mention of a human-in-the-loop component for the performance evaluation itself. The device provides a quantitative measurement, and a cutoff is applied to this measurement for clinical interpretation.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment of AMI (rule-in/rule-out) was based on:

• Clinical diagnosis of AMI: This would typically involve a combination of patient symptoms (chest pain of 20 minutes duration), serial measurements of cardiac markers, and potentially ECG findings.
• Comparison to a "gold standard biochemical marker, CK-MB": This served as a key reference for determining the clinical accuracy of the Troponin I assay.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for a "training set." This type of IVD device typically undergoes extensive analytical validation (precision, linearity, sensitivity) and then clinical validation. The "optimal cutoff of 0.15 ng/ml" was determined from ROC curve analysis on "all subject results" (which included the 289 subjects in the multi-site prospective study), suggesting that the clinical validation set was also used for defining this cutoff rather than a separate, explicitly defined "training set" in the machine learning sense.

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

As noted above, a distinct "training set" in the machine learning sense is not explicitly described. However, if the determination of the "optimal cutoff of 0.15 ng/ml" is considered part of a "training" or optimization process, then the ground truth for this optimization was established using the clinical diagnosis of AMI (rule-in or rule-out) for the 289 subjects in the prospective study. This clinical diagnosis would have been based on standard medical criteria at the time.

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The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum, using the ACCESS® Immunoassay System.

Here's a breakdown of the acceptance criteria and study details for the ACCESS® Troponin I assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary doesn't explicitly state pre-defined acceptance criteria with specific numerical targets. Instead, it describes key performance metrics and then concludes that the device demonstrates "acceptable diagnostic efficiency" and "substantially equivalent performance" to predicate devices. Below, I've listed the reported performance metrics that would likely have been part of the implicit acceptance criteria for such a device.

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

• Test Set Sample Sizes:
  • AMI rule-in/rule-out: 289 subjects
  • Correlation with Stratus® Troponin I: 201 patients
  • Correlation with CK-MB: 208 subjects
  • Skeletal muscle injury specificity: 58 patients
  • Renal disease specificity: 81 subjects
• Data Provenance: The study was a "multi-site prospective study" where subjects presented to the emergency department with chest pain. While specific countries are not mentioned, the context (FDA 510(k) in the US) typically implies US-based clinical sites unless otherwise specified.

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

The summary does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth (diagnosis of AMI). However, given that it's a clinical study for ruling in/out AMI, it's highly probable that physicians (e.g., emergency physicians, cardiologists) were involved in determining the final diagnosis based on standard clinical practice, including clinical presentation, ECG changes, and serial biomarker measurements. The "diagnosis" would have been established using comprehensive clinical criteria, not solely a single expert's opinion.

4. Adjudication Method for the Test Set

The summary does not specify an explicit adjudication method (e.g., 2+1, 3+1). The diagnosis of AMI in the "rule-in or rule-out AMI" study context would likely have been based on established clinical guidelines and physician judgment, rather than a formal, multi-reader consensus process as seen in imaging studies. Each patient contributed a minimum of two serum samples to establish the diagnosis, implying a longitudinal assessment was part of the diagnostic process.

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 is more common for imaging devices where human readers interpret images with and without AI assistance. This submission describes an in-vitro diagnostic (IVD) immunoassay, where the device provides a quantitative numerical result, not an interpretation that human readers would directly assist with. Therefore, comparing human reader performance with and without AI assistance is not applicable in this context.

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

Yes, the study primarily evaluates the standalone performance of the ACCESS® Troponin I assay. The reported sensitivity, specificity, and concordance values are for the device itself, providing its quantitative measurement and diagnostic classification without human interpretation of its output. The device outputs a numerical value, and then a cutoff (0.15 ng/ml) is applied to classify the result.

7. The Type of Ground Truth Used

The ground truth for Acute Myocardial Infarction (AMI) was established through clinical diagnosis based on standard medical practice, referred to as "rule-in or rule-out AMI." This would involve a combination of:

• Clinical presentation (chest pain of 20 minutes duration).
• Serial serum samples (minimum of two) to observe changes in cardiac biomarkers.
• Presumed other clinical data (e.g., ECG findings, medical history), though not explicitly detailed in the summary.
• The comparison to CK-MB, which was considered the "current gold standard biochemical marker" at the time, also served as a reference for establishing the clinical utility of troponin I.

8. The Sample Size for the Training Set

The summary does not provide details on a separate training set size. It describes a "multi-site prospective study" that appears to serve as the primary clinical validation (test set). For IVD devices like this immunoassay, the "training" (development/calibration) of the assay itself occurs during the manufacturing and R&D phases to optimize reagents, calibrate reference materials, and establish analytical performance characteristics. These are typically not reported as a "training set" in the same way an AI/ML model would describe it. The 289 subjects likely contributed to the clinical evaluation, and no distinction is made for a separate training portion.

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

As noted above, a distinct "training set" with independent ground truth establishment, as typically understood in AI/ML, isn't described for this IVD device. The development and analytical characterization of the assay (e.g., determining linearity, precision, analytical sensitivity) would have involved laboratory experiments with known concentrations of troponin I and clinical samples, but this is part of assay development rather than a ground truth establishment for an AI training set.

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