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510(k) Data Aggregation
(287 days)
CryovCheck™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay.
Cryo✓Check™ Factor XII Deficient Plasma is frozen human plasma deficient in the Factor XII coagulation factor. It is prepared from citrated pooled normal human plasma which has been depleted of Factor XII by immunoadsorption. Activity levels of Factor XII are assayed at less than 1% normal levels while all other coagulation factors are greater than 50%.
Acceptance Criteria and Study Details for Cryo✓Check™ Factor XII Deficient Plasma
The device's performance was evaluated through an "Open Vial Stability" study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (24 Hours) |
|---|---|
| Mean (+/-) 5% of reference value | 93 (within 5% of reference value, as 92.9% is the overall average) |
| %C.V. < 5% | 3.4% (for 24 hours) |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 5
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that Precision Biologicals Incorporated is located in Dartmouth, Nova Scotia, Canada, it is likely the study was conducted in Canada. The nature of stability testing suggests it was a prospective study.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This study focuses on the stability of a diagnostic reagent, not on interpreting images or clinical cases that would require expert consensus for ground truth. The "ground truth" reference value would be established by the assay's own internal standards.
4. Adjudication Method
Not applicable. The study involved quantitative measurements of factor XII activity, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study comparing human readers with and without AI assistance. It's a stability study for a diagnostic reagent.
6. Standalone Performance
The study primarily evaluates the standalone performance of the Cryo✓Check™ Factor XII Deficient Plasma in terms of its ability to maintain its reference value over time.
7. Type of Ground Truth Used
The ground truth used is a reference value established by the assay itself. The document states "Reference Value =" and implies the reported mean, maximum, and minimum values are compared against this reference. The specific method for determining this absolute reference value is not detailed, but it would typically involve calibrating against known standards.
8. Sample Size for Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable. No training set was used.
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