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The Cardiac Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the cardiac troponin I method on the Stratus® CS analyzer. This calibrator is a device intended to establish a point of reference that is used in the determination of troponin I values.

The Stratus® CS cTnI CalPak is a plastic cartridge, which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concertration to troponin complex per well is 40 ng/mL. The CalPak is a single-use product.

The provided document is a 510(k) summary for the Dade Behring Stratus® CS Troponin I Calibrator (cTnI CalPak). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new clinical diagnostic device. Therefore, much of the requested information, such as sample sizes, expert involvement, and ground truth methodologies related to a formal performance study, is not present in this document.

However, I can extract the acceptance criteria for equivalency and describe the comparison made.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on "substantial equivalence" to a predicate device. The performance is assessed by comparing key attributes of the new device to the predicate.

Note on Acceptance Criteria: In this context, "acceptance criteria" revolve around demonstrating that the modified device is substantially equivalent to the predicate device, implying that any differences do not raise new questions of safety or effectiveness. The change in matrix from buffered bovine protein to normal human serum is noted as the primary modification, but the conclusion is still substantial equivalence.

Regarding other requested information, it is not available in this document:

2. Sample size used for the test set and the data provenance: Not applicable as this is a comparison for substantial equivalence, not a performance study with a test set of patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a calibrator, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the calibrator would be its assigned value and consistency, which is implicitly accepted by demonstrating equivalence to the predicate calibrator.
8. The sample size for the training set: Not applicable. This calibrator does not involve a training set as it's not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

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The Cardiac Troponin-I Calibrator (TROP CalPak) is intended to be used to calibrate the Cardiac Troponin I method on the Stratus® CS analyzer.

The Stratus® CS TROP CalPak is a plastic cartridge which contains buffered bovine protein with native human troponin complex in three of the reagent wells. The approximate concentration of troponin complex per well is 40 ng/mL. The CalPak is a single-use product.

This document is a 510(k) premarket notification for a medical device called the Stratus® CS Troponin I Calibrator (TROP CalPak). It is not a study report that includes acceptance criteria and performance data for a device in the way you've described for an AI/algorithm-based device.

The document primarily focuses on establishing "substantial equivalence" of a modified calibrator to a previously marketed calibrator. This regulatory process does not typically involve the kinds of performance studies, acceptance criteria, ground truth, or expert review that would be associated with a new diagnostic algorithm or device determining a medical outcome.

Therefore, I cannot extract the information you requested because it is not present in this document. Here's why and what kind of information is contained:

Why the requested information is not present:

• Nature of the Device: The device is a "calibrator," meaning it's a reference material used to ensure the accuracy of an analyzer (the Stratus® CS analyzer) that measures Cardiac Troponin I. It's not a diagnostic device that directly interprets patient data, makes a diagnosis, or an AI/algorithm.
• Regulatory Goal: The purpose of this 510(k) submission is to demonstrate that the modified calibrator is "substantially equivalent" to an already cleared calibrator. This relies on demonstrating that their intended use, operating principles, design, materials, etc., are similar enough that the new device is as safe and effective as the predicate. It does not require a de novo performance study against a ground truth as would be needed for a new diagnostic claim or an AI algorithm.
• "Acceptance Criteria" for a Calibrator: For a calibrator, "acceptance criteria" would typically relate to its manufacturing specifications, stability, and its ability to consistently produce expected values on the analyzer. These are internal manufacturing and quality control parameters, not performance metrics against a clinical ground truth.

What is available in the document:

• Predicate Device: Stratus® CS TROP CalPak (K981100)
• Differences from Predicate: The main difference is the "Analyte" source (Native human troponin complex vs. Troponin-I peptide fragment). Target Concentration also differs (40 ng/mL vs. 45 ng/mL).
• Conclusion: The modified calibrator is "substantially equivalent" based on the comparison provided.

In summary, this document is a regulatory submission for a laboratory calibrator, not a study evaluating an AI/algorithmic device's diagnostic performance. Therefore, it does not contain the information you asked for regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert review for diagnostic accuracy.

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