(371 days)
BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).
Biophen Antithrombin 2.5 and 5 kit, an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma to monitor the Antithrombin concentration in human plasma, in instances of recurrent thrombosis resulting from a congenital or acquired deficiency of Antithrombin.
The provided text describes the Biophen Antithrombin device and its performance relative to a predicate device, Coamatic® Antithrombin. The study presented here is focused on demonstrating substantial equivalence to the predicate device, not on establishing de novo clinical utility or a standalone performance against a clinical ground truth.
Here's an analysis based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for substantial equivalence in this context is a strong correlation with the predicate device and acceptable reproducibility (intra-assay and inter-assay variability).
| Acceptance Criteria | Reported Device Performance (Biophen® Antithrombin) |
|---|---|
| Correlation with Predicate Device (Coamatic® Antithrombin) | 0.99 |
| Intra-Assay Reproducibility | Sample 1: 0.73% CV |
| Sample 2: 0.66% CV | |
| Sample 3: 0.92% CV | |
| Inter-Assay Reproducibility | Sample 1: 2.57% CV |
| Sample 2: 2.49% CV | |
| Sample 3: 3.72% CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 21 samples
- Data Provenance: The plasma samples were "received from hospital," implying they are clinical samples. The country of origin is not explicitly stated, but the submission is from Hyphen Biomed, France, and the FDA review process is for the US market. It is retrospective as samples were "received from hospital" and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study does not involve establishing ground truth by human experts in the typical sense for diagnostic imaging or subjective assessments. Instead, the performance of the new device (Biophen Antithrombin) is compared to the results obtained by a predicate device (Coamatic® Antithrombin), which serves as the "reference" or "ground truth" for the comparison of analytic performance. Therefore, no human experts were used to establish the "ground truth" for the test set in this context. The "truth" is established by the measurements of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, there was no expert adjudication process. The comparison was directly between the quantitative results of two laboratory devices.
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 (IVD) device for quantitative determination of Antithrombin, not an imaging AI or a device that assists human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a way. The "performance data" provided clearly represents the standalone analytical performance of the Biophen Antithrombin device. It measures the Antithrombin concentration directly from plasma samples. There is no human "in the loop" impacting the quantitative measurement itself, beyond handling the samples and operating the automated system (ACL, BCS). The comparison to the predicate device is also a standalone comparison of two device-generated results.
7. The Type of Ground Truth Used
The "ground truth" for this study is not a clinical outcome or pathology report, but rather the results obtained from the legally marketed predicate device, Coamatic® Antithrombin. The study aims to demonstrate that Biophen Antithrombin produces results substantially equivalent to an already approved device.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" for the Biophen Antithrombin device itself. This is an IVD kit, not a machine learning algorithm that requires a training set in the conventional sense. The development of such a kit would involve internal validation and optimization, but these details are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning algorithm. The "training" of an IVD device like this would involve internal R&D to define reagents and protocols, but this is not disclosed in the summary.
§ 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).