(54 days)
IL Test™ Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate. Dysplasminogenemia is associated with recurrent venous thrombosis. Acquired deficiencies of Plasminogen are associated with thrombolytic therapy, sepsis and Disseminated Intravascular Coagulation.
IL Test™ Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate.
The provided text describes the IL Test™ Plasminogen, an in vitro diagnostic test. Analyzing the text, we can extract the following information regarding its acceptance criteria and the study that proves its performance:
1. Table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation (r) to Predicate (ACL 300) | Substantially equivalent to predicate, implying high correlation. | 0.983 |
| Correlation (r) to Predicate (ACL Futura) | Substantially equivalent to predicate, implying high correlation. | 0.989 |
| Within-run Precision (ACL 300, 50.1% activity) | Substantially equivalent to predicate, implying acceptable CV. | CV of 4.4% |
| Within-run Precision (ACL 300, 95.7% activity) | Substantially equivalent to predicate, implying acceptable CV. | CV of 2.8% |
| Within-run Precision (ACL Futura, 52.5% activity) | Substantially equivalent to predicate, implying acceptable CV. | CV of 1.8% |
| Within-run Precision (ACL Futura, 97.6% activity) | Substantially equivalent to predicate, implying acceptable CV. | CV of 1.7% |
Note: The document states that the new device "is substantially equivalent in performance, intended use and safety and effectiveness" to the predicate device. Therefore, the "acceptance criteria" are not explicitly defined as numerical thresholds but rather by demonstrating performance comparable to the legally marketed predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size: 51 plasma samples
- Data Provenance: Not specified (e.g., country of origin). The study is retrospective in nature, as it uses existing plasma samples for method comparison.
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. The "ground truth" for method comparison is essentially the results obtained from the predicate device; therefore, expert consensus on the true value of plasminogen in these samples is not explicitly mentioned as a separate step.
4. Adjudication method for the test set
- This information is not applicable to this type of study. Adjudication methods (like 2+1, 3+1) are typically used in diagnostic studies where multiple readers interpret images or clinical data to establish a consensus ground truth. Here, the "ground truth" for performance comparison is the result from the predicate device.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic test for plasminogen, not an AI-assisted diagnostic tool that would involve human readers interpreting output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The reported performance metrics (correlation and precision) are based on the device's quantitative measurements of plasminogen activity directly from plasma samples. There is no human interpretation involved in the measurement process itself, making this an algorithm-only (or device-only) performance assessment.
7. The type of ground truth used
- The "ground truth" used for comparison in this study is the results obtained from the predicate device (IL Test™ Plasminogen K864212/A) using the same plasma samples. This indicates a comparative effectiveness study against an established method.
8. The sample size for the training set
- This information is not applicable to this device. The IL Test™ Plasminogen appears to be a laboratory reagent-based test with a fixed assay protocol, not a machine learning or AI-based device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- This information is not applicable as there is no "training set" for this type of device.
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).