(129 days)
Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as a - antiplasmin, is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods.
Here's a breakdown of the acceptance criteria and study particulars for the Coamatic® Plasmin Inhibitor device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The device's performance was compared to a predicate device, the Coatest® Antiplasmin, demonstrating substantial equivalence. The key performance metrics are correlation and precision.
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance / Target | Reported Device Performance (Coamatic® Plasmin Inhibitor) | Assessment |
|---|---|---|---|---|
| Method Comparison | Correlation (r) | Demonstrated substantial equivalence to Coatest® Antiplasmin | Met | |
| ACL 300 (n=61) | Not explicitly stated as a value, but implied to be high for equivalence | 0.95 | Met | |
| Cobas Mira (n=43) | Not explicitly stated as a value, but implied to be high for equivalence | 0.97 | Met | |
| MLA Electra (n=43) | Not explicitly stated as a value, but implied to be high for equivalence | 0.97 | Met | |
| Test Tube (n=32) | Not explicitly stated as a value, but implied to be high for equivalence | 0.96 | Met | |
| Microplate (n=54) | Not explicitly stated as a value, but implied to be high for equivalence | 0.94 | Met | |
| Precision | Within-run CV | Not explicitly stated as a specific numerical target for CV | 5.9% (at 44.8% plasmin inhibitor concentration) | Met |
| 2.7% (at 99.3% plasmin inhibitor concentration) | Met |
2. Sample Sizes and Data Provenance for Test Set
For the method comparison studies, the sample sizes varied depending on the instrument/method used:
- ACL 300: n=61
- Cobas Mira: n=43
- MLA Electra: n=43
- Test Tube method: n=32
- Microplate method: n=54
The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications for establishing ground truth. The study is a method comparison, where the predicate device's results serve as the reference, rather than establishing a de novo ground truth by experts.
4. Adjudication Method for Test Set
The document does not mention any adjudication method like 2+1 or 3+1. This is expected given it's a method comparison study between two in vitro diagnostic tests, where the "ground truth" is typically defined by the predicate device's results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically relevant for interpretative devices where human performance with and without AI assistance is being evaluated (e.g., radiology AI). The Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for quantitative determination, not an interpretative device requiring human readers in the loop.
6. Standalone (Algorithm Only) Performance
Yes. The reported performance is inherently standalone, as it describes the device's accuracy and precision in isolating and quantifying plasmin inhibitor activity. There is no human interpretation component described for the device's output itself. The comparison is between two analytical methods.
7. Type of Ground Truth Used
The "ground truth" for this study was the results obtained from the legally marketed predicate device, Coatest® Antiplasmin. The study aimed to demonstrate substantial equivalence by comparing the new device's measurements to those of the established predicate.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is typical for an IVD device submission that focuses on validation against a predicate rather than a machine learning model that requires a distinct training phase.
9. How Ground Truth for Training Set Was Established
Since no training set is mentioned (as this is not a machine learning-based device), this information is not applicable and not provided in the document.
§ 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).