(85 days)
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):
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (VITROS Troponin I assay) |
|---|---|---|
| Correlation to Predicate Device | Substantially equivalent performance to the DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method. This implies a strong linear relationship and good agreement in measurements. | VITROS Troponin I assay = 1.05 x X - 0.151 (ng/mL), where X is DADE Dimension RxL Cardiac Troponin-I assay. Spearman rank correlation coefficient of 0.983. |
| Calibration Range | Expected to be comparable or better than the predicate device. | 0-100 ng/mL |
| Basic Principle | Solid phase immunoassay with enzyme-labeled tracer and mouse monoclonal anti-Troponin I antibody. | Matches the predicate device: Solid phase immunoassay with enzyme-labeled tracer and mouse monoclonal anti-Troponin I antibody (Biotinylated antibody reagent), with goat polyclonal anti-Troponin I antibody (HRP-Conjugate reagent). |
| Sample Type | Serum and plasma (heparin). | Serum and plasma (EDTA or heparin). (Wider range of sample types than predicate) |
| Sample Volume | 60 μL | 50 μL (Lower volume than predicate) |
| Incubation Time and Temperature | 5.4 minutes at 37°C | 8 minutes at 37°C |
| Intended Use | Aid in the diagnosis of myocardial infarction through quantitative measurement of Troponin I. | Matches the predicate device. |
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.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.