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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.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which often focuses on substantial equivalence rather than detailed performance studies and acceptance criteria as might be found in a full efficacy report. Therefore, some of the requested information (like specific effect sizes for MRMC, sample sizes for test sets, and detailed expert qualifications) is not present in this type of document. I will extract what is available and indicate when information is missing.

Acceptance Criteria and Device Performance Study

The provided document describes the Vitros Troponin I assay, intended for the in vitro quantitative measurement of Troponin I (cTnI) in human heparin plasma to aid in the diagnosis of myocardial infarction. A key focus of this submission is a modification to the assay's interpretation of results, specifically introducing a repeat testing algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table. Instead, it describes a "modification to the interpretation of results" which aims to "minimize the likelihood of an end user obtaining an occasional falsely elevated non repeatable result." The implicit performance objective is to reduce false positives, particularly those that are non-repeatable.

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

The document does not provide specific details on the sample size used for a test set to evaluate the modified algorithm, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature) for this particular study. The submission focuses on the modification of interpretation for an already cleared device.

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

This information is not provided in the document. The document primarily discusses an analytical modification to an in vitro diagnostic device, not a diagnostic imaging or algorithmic interpretation task that would typically rely on expert ground truth for a test set in the same manner.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC study was not done as this is an in vitro diagnostic assay and the modification concerns an algorithm for interpreting results, not human reader performance with or without AI assistance. This type of study is not applicable to the device described.

6. If a Standalone Study Was Done

The modification described is inherently standalone in its nature, as it's an algorithm applied to the device's output to "interpret results" before they are reported. The modification itself is the algorithm "without human-in-the-loop performance" for its direct application. However, the document does not detail a specific "standalone study" with quantifiable metrics for this new algorithm beyond the statement of its intended effect. The original performance characteristics of the assay itself would have been established in the previous K020662 submission, but those details are not provided here.

7. The Type of Ground Truth Used

Given that this is an in vitro diagnostic assay for cardiac Troponin I (cTnI) to aid in the diagnosis of myocardial infarction, the ground truth for establishing the original assay's performance would likely have involved:

• Clinical Diagnosis: Patients with a confirmed diagnosis of myocardial infarction (based on clinical presentation, ECG changes, other cardiac biomarkers, and potentially imaging).
• Reference Methods: Comparison against established and validated laboratory methods for measuring cTnI, if applicable, or against a detailed clinical "truth" ascertained by a panel of clinicians.

For the modification described in this 510(k), which pertains to minimizing "falsely elevated non repeatable results," the implicit ground truth would involve:

• Repeatability/Precision Studies: Assays of the same sample run multiple times to assess repeatability. A result would be "false elevated non-repeatable" if an initial elevated reading could not be consistently replicated in subsequent tests of the same sample, and the patient's clinical status did not support an actual elevation.

The document does not explicitly state the ground truth methodology for this specific modification study.

8. The Sample Size for the Training Set

The document does not contain information regarding a training set sample size. This type of information is typically associated with machine learning models. The modification described appears to be an algorithmic rule for interpretation rather than a learned model.

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

Since there is no mention of a training set, this information is not applicable from the provided text.

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