(92 days)
The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin). When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
The ADVIA IMS® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the TnI-Ultra assay on the ADVIA IMS® system
The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin).
The provided text describes the 510(k) summary for the Troponin I Ultra (TnI-Ultra) Assay for Bayer ADVIA IMS®, submitted in 2005. It details the device's intended use and presents performance data by comparing it to a predicate device, the Bayer ACS:180® cTnI Assay.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as clear pass/fail thresholds for each test, but rather presents the performance of the new device (ADVIA IMS® TnI-Ultra Assay) alongside the predicate device (Bayer ACS:180® cTnI Assay) for comparison, implying that similar or improved performance relative to the predicate device is the goal.
| Performance Metric | Predicate Device Performance (Bayer ACS:180® cTnI Assay) | ADVIA IMS® TnI-Ultra Assay Performance |
|---|---|---|
| Imprecision (Total CV%) | ||
| Level 0.80 ng/mL | 7.5 | N/A (different levels reported) |
| Level 1.37 ng/mL | 6.7 | N/A (different levels reported) |
| Level 15.73 ng/mL | 5.0 | N/A (different levels reported) |
| Level 33.83 ng/mL | 5.3 | N/A (different levels reported) |
| Level 43.01 ng/mL | 5.8 | N/A (different levels reported) |
| Level 1.55 ng/mL | N/A (different levels reported) | 5.7 |
| Level 14.06 ng/mL | N/A (different levels reported) | 2.2 |
| Level 32.93 ng/mL | N/A (different levels reported) | 2.7 |
| Level 0.21 ng/mL | N/A (different levels reported) | 5.4 |
| Level 9.05 ng/mL | N/A (different levels reported) | 2.7 |
| Correlation (Serum, Linear Regression) | Y = 0.90 * X + 0.43 (X=Predicate) | N/A (New device is Y) |
| Regression Equation | N/A (New device is Y) | |
| Syx (ng/mL) | 2.64 | N/A (New device is Y) |
| R | 0.954 | N/A (New device is Y) |
| Correlation (Serum, Passing Bablok) | Y = 1.01 * X - 0.01 (X=Predicate) | N/A (New device is Y) |
| Regression Equation | N/A (New device is Y) | |
| Interfering Substances (% Deviation) | ||
| Albumin | Not explicitly stated | 1.9 |
| Bilirubin | Not explicitly stated | -3.3 |
| Hemoglobin | Not explicitly stated | -4.7 |
| Triglyceride | Not explicitly stated | -3.8 |
| Analytical Range | 0.10 ng/mL to N/A (implicit range) | 0.01 ng/mL to 50 ng/mL |
| Minimum Detectable Concentration | 0.10 ng/mL | 0.01 ng/mL |
| 99th Percentile | Not explicitly stated | 0.04 ng/mL (healthy donors) |
| Functional Sensitivity (10% total C.V.) | Not explicitly stated | 0.03 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Imprecision: The sample size for the imprecision study is not explicitly stated, beyond the "Level" values. The data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Correlation:
- Sample Size (N): 97 serum specimens.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Interfering Substances: The sample size is not explicitly stated. The data provenance is not specified.
- 99th Percentile Distribution:
- Sample Size: 337 serum samples from "apparently healthy donors."
- Data Provenance: Not specified, but implied to be human serum samples.
- Expected Results (AMI patients):
- Sample Size: 112 AMI patients.
- Data Provenance: Not specified, but implied to be human serum samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not applicable to this analysis. The device is an immunoassay measuring a biochemical marker, where "ground truth" is defined by the laboratory measurement or clinical diagnosis rather than expert interpretation of images or clinical findings in the same way as, for instance, a diagnostic imaging AI. For the 99th percentile, the value is derived statistically from a population of healthy individuals. For AMI patients, the diagnosis (and thus the "ground truth" for the AMI group) would typically be established based on a combination of clinical symptoms, ECG changes, and serial cardiac marker measurements, not a single expert review of a test set in the context of an expert consensus.
4. Adjudication Method for the Test Set
Not applicable for this type of in vitro diagnostic device test. The "truth" in these studies is determined by the analytical measurement or clinical diagnosis criteria, not by human adjudication of independent expert opinions on a specific test result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes an in vitro diagnostic assay, which is a laboratory test, not an imaging interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance presented for the ADVIA IMS® TnI-Ultra Assay (imprecision, correlation, analytical range, minimum detectable concentration, 99th percentile, functional sensitivity, interference) represents its standalone performance as an automated in vitro diagnostic test, without human-in-the-loop performance enhancement for the test's operation itself. Human interpretation is required for the clinical use of the results (e.g., using the TnI-Ultra values in conjunction with other clinical data for AMI diagnosis), but the performance metrics provided are for the assay's analytical capabilities.
7. The Type of Ground Truth Used
- Clinical Diagnosis / Reference Assay Comparison: For correlation with the predicate device, the predicate device's results serve as a comparative "ground truth" or reference.
- Statistical Derivation from Healthy Population: The 99th percentile value is derived statistically from a population of apparently healthy donors.
- Clinical Diagnosis (AMI): For the "Expected Results" table, the "AMI patients" category implies that these individuals had a clinical diagnosis of Acute Myocardial Infarction, which serves as the ground truth for that group.
- Controlled Laboratory Spiking: For interfering substances, the "expected" recovery is the ground truth, and the observed recovery is compared against it.
8. The Sample Size for the Training Set
The document does not explicitly state a "training set" sample size in the context of machine learning or algorithm development. For an immunoassay, the development (akin to "training") involves optimizing reagents, reaction conditions, and calibration, which typically uses a variety of samples but isn't usually quantified as a "training set" in the same way as for AI algorithms. The provided data represents validation studies, not training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" described in the context of an AI algorithm, this question is not applicable. The development of an immunoassay involves analytical chemistry and biochemical principles, where "ground truth" during development involves known concentrations, spiked samples, and comparison to established reference methods or clinical samples with known diagnoses.
§ 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.