(14 days)
IMMULITE® Troponin I is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma. It is intended strictly for in vitro use as an aid in the diagnosis of acute myocardial infarction (AMI).
IMMULITE® Turbo Troponin I is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. Turbo Troponin I is a solid-phase, two-site chemiluminescent enzyme IMMULITE® IMMODETTE Thiroo - Hopenin 1- 15-a USMULITF Automated Analyzer and designed for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma.
The provided text is a 510(k) summary for the IMMULITE® Turbo Troponin I device, which is an in vitro diagnostic assay. It primarily focuses on regulatory approval and substantial equivalence to a predicate device.
Unfortunately, the provided document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, and details on ground truth establishment (number of experts, qualifications, adjudication).
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Sample size and ground truth establishment for the training set.
The document states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration (FDA) used to find DPC substantial equivalence for IMMULITE® Turbo Troponin I." However, this summary itself does not present that data, but rather attests to its submission to the FDA.
Therefore,Based on the provided document, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given 510(k) summary. The document states that data was presented to the FDA to establish substantial equivalence, but the specifics of that data, including performance metrics against acceptance criteria, are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the given 510(k) summary. Given that this is an in vitro diagnostic device for quantitative measurement of Troponin I, the "ground truth" would typically come from clinical diagnosis (e.g., diagnosis of Acute Myocardial Infarction by clinicians) and potentially other established diagnostic methods, rather than expert interpretation of images/signals by a specific number of experts in the way that an AI for imaging would. However, the details of how this was established are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given 510(k) summary.
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:
This information is not applicable/not provided. This device is an automated immunoassay analyzer for quantitative measurement of a biomarker (Troponin I), not an AI-assisted diagnostic imaging device requiring human "readers" in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described is an "Automated Immunoassay Analyzer" that performs "quantitative measurement of troponin I". This implies a fully automated, standalone performance of the analytical measurement. However, the performance metrics of this standalone operation are not detailed in the summary. The intended use specifies it is "an aid in the diagnosis of acute myocardial infarction (AMI)," meaning the result requires interpretation by a clinician, but the measurement itself is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The device is intended as "an aid in the diagnosis of acute myocardial infarction (AMI)." Therefore, the "ground truth" for evaluating its effectiveness would likely be based on:
* Clinical diagnosis of AMI: Established by a combination of clinical symptoms, ECG changes, and other cardiac biomarker levels (e.g., CK-MB, Myoglobin, serial Troponin measurements if a reference method was used).
* Outcomes data: Although typically not the primary "ground truth" for an acute diagnostic, long-term patient outcomes linked to a confirmed AMI diagnosis would be relevant.
The specific method for establishing this ground truth in the study is not described in the summary.
8. The sample size for the training set:
This information is not provided in the given 510(k) summary. For an immunoassay device, the concept of a "training set" in the context of machine learning (as often implied by this question in AI/ML performance studies) is usually not directly applicable. Instead, there would be studies for assay development, optimization, calibration, and validation, which involve significant sample testing. The details of these are not here.
9. How the ground truth for the training set was established:
This information is not provided in the given 510(k) summary.
§ 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.