(52 days)
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
The provided text describes the IL Test™ Antithrombin device and its performance relative to a predicate device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the IL Test™ Antithrombin. Instead, it demonstrates performance by comparing it to a predicate device and reporting precision metrics. For the purpose of this response, the performance metrics reported for the new device can be considered against the implicit acceptance that they demonstrate substantial equivalence to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance (IL Test™ Antithrombin) |
|---|---|
| Method Comparison (Correlation to Predicate) | |
| Substantial equivalence to predicate device (implied by high correlation) | ACL 300 vs. predicate Coamatic® Antithrombin: r = 0.992 (evaluated using 52 plasma samples) |
| ACL Futura vs. predicate Coamatic® Antithrombin: r = 0.991 (evaluated using 52 plasma samples) | |
| Within-Run Precision (CV%) | |
| Low coefficient of variation (CV%) for consistency | ACL 300: |
- Mean 49.2% activity: CV = 3.6%
- Mean 103.7% activity: CV = 1.6% |
| | ACL Futura: - Mean 48.7% activity: CV = 3.9%
- Mean 104.5% activity: CV = 3.0% |
2. Sample size used for the test set and the data provenance
- Sample Size: 52 plasma samples
- Data Provenance: Not explicitly stated (e.g., country of origin). Since it's a medical device for human plasma, the samples were presumably human in origin. The study appears to be retrospective given the comparison to an existing predicate device using collected samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" is typically established by the reference method (the predicate device in this case) and the inherent biological characteristics of the samples, rather than human expert interpretation of raw data.
4. Adjudication method for the test set
Not applicable. The study involves quantitative measurement and comparison to a predicate device, not qualitative assessments requiring adjudication by multiple experts.
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 for quantitative determination in human plasma, not an AI-assisted diagnostic tool that involves human readers interpreting images or other data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this study represents a standalone performance evaluation of the IL Test™ Antithrombin device itself, without human-in-the-loop interaction for interpretation beyond standard laboratory operation. The device directly measures Antithrombin levels.
7. The type of ground truth used
The ground truth for this comparison study was established by the predicate device, Coamatic® Antithrombin. The new device's measurements were compared against the established measurements from the predicate device to demonstrate substantial equivalence.
8. The sample size for the training set
This document describes a performance evaluation (test set), not the development of an algorithm requiring a separate training set. Therefore, this information is not applicable/provided.
9. How the ground truth for the training set was established
As described in point 8, this document does not refer to a training set for an algorithm.
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).