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IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.

IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency.

This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

Here's a breakdown of the acceptance criteria and study information for the IL Test™ Liquid Antithrombin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (IL Test™ Antithrombin). The key performance metrics are method comparison (correlation with the predicate) and within-run precision.

Interpretation of Acceptance: The reported performance metrics (slopes close to 1, correlation coefficients very close to 1, and low %CVs) strongly indicate that the device meets the implied acceptance criteria for substantial equivalence to the predicate device.

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

• Sample Size: 118 citrated plasma samples.
  • 40 normal samples
  • 78 abnormal samples
• Data Provenance: The document does not explicitly state the country of origin. It is a prospective study in the sense that these samples were tested specifically for the purpose of this comparison. However, whether the samples themselves were collected prospectively or retrospectively from a biobank is not specified.

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

This type of in vitro diagnostic device (IVD) study does not typically involve human expert interpretation of images or other subjective data for ground truth establishment. For method comparison studies in IVDs, the "ground truth" (or reference standard) is the result obtained from the predicate device. Therefore, the concept of "experts" in the context of establishing ground truth as you'd find in an AI imaging study is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the ground truth is the predicate device's result. There is no subjective interpretation requiring adjudication.

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 an in vitro diagnostic device, not an AI imaging or diagnostic algorithm designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is effectively a standalone performance study. The IL Test™ Liquid Antithrombin system (analyzer + reagents) is compared directly to the predicate device, operating without human interpretation influencing the numerical result.

7. The Type of Ground Truth Used

The ground truth for the method comparison study was established by the predicate device's performance. The new device's results were compared to those obtained using the established K980499 IL Test™ Antithrombin.

8. The Sample Size for the Training Set

There is no mention of a training set in the context of machine learning or AI. This device is a diagnostic assay (reagents and an automated system) based on a chemical reaction, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of IVD device.

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