(28 days)
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods. The measurement of Factor VIII is used as an aid in the indentification of factor VIII deficiency or to monitor patients on replacement therapy as well as for potency estimation of FVIII concentrates.
Coamatic® Factor VIII is an in vitro diagnostic test for the quantitative determination of Factor VIII activity in human citrated plasma using manual, microplate and automated methods.
The provided text describes the Coamatic® Factor VIII device, its intended use, and a summary of performance data comparing it to a predicate device, Coatest® Factor VIII. It also includes the FDA's 510(k) clearance letter.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device (r) | High correlation (close to 1.0) | 0.99 (compared to Coatest® Factor VIII) |
| Within-run Precision (CV) | Low CV, indicating good reproducibility | 1.87% (at 1.0 IU/mL FVIII) |
| 2.57% (at 0.21 IU/mL FVIII) | ||
| 2.76% (at 0.025 IU/mL FVIII) |
Note: The document implicitly suggests that substantial equivalence to the predicate device in performance is the acceptance criterion. The high correlation and low CV values demonstrate that the Coamatic® Factor VIII meets this implied criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 69 plasma samples for the method comparison study.
- Data Provenance: Not explicitly stated, but the mention of "human citrated plasma" suggests human biological samples were used. The country of origin and whether the data was retrospective or prospective are not provided in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study described is a method comparison and precision study, not one that typically involves expert ground truth establishment in the traditional sense of diagnostic accuracy for subjective interpretation. The "ground truth" for the comparison is the measurement from the predicate device.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. The study involves quantitative measurements and comparison between devices, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted. The study focused on device performance (correlation and precision) rather than the impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, effectively. The performance data presented (correlation and precision) are for the device (Coamatic® Factor VIII) itself, measuring Factor VIII activity. This represents the standalone performance of the analytical method.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the measurements obtained from the predicate device (Coatest® Factor VIII) for the method comparison, and the known concentrations of Factor VIII in the samples for the precision study (as implied by "at a Factor VIII concentration of..."). It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is an in vitro diagnostic assay, not an AI/machine learning algorithm that typically requires a distinct training set. The "development" of such assays involves establishing reagents, reaction conditions, and calibration, rather than training on labeled data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As explained above, the concept of a "training set" and "ground truth for a training set" as used for AI algorithms does not directly apply to this type of in vitro diagnostic device. The development process would involve optimizing the assay's chemical and enzymatic reactions, reagent concentrations, and calibration curves.
§ 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).