Search Results

Cryov Check™ Factor 2 Deficient Plasma is recommended for use as a substrate in clot-based factor II assays using the one stage prothrombin time (PT) assay.
Cryov Check™ Factor 2 Deficient Plasma is human plasma deficient in the Factor II coagulation protein while having all other coagulation factors within normal limits. It is recommended for use as a substrate in clot-based Factor II assays using the one stage prothrombin time (PT).

Device Description

CryovCheck™ Factor 2 Deficient Plasma is frozen human plasma deficient in the Factor II coagulation protein. It is prepared from citrated pooled normal human plasma which has been depleted of Factor II by immunoadsorption. Activity levels of Factor II are assayed at less than 1% normal levels while all other coagulation factors are within normal levels.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Factor II activity level	Less than 1% normal levels
All other coagulation factors	Within normal limits
24-hour open vial stability (PT and APTT assays)	No anomalous results detected
24-hour open vial stability (Factor II recovery, Mean (% recovery), 2 SD, CV%)	Mean Factor II recovery: 83.07% (Reference Value = 85%). Max: 87%, Min: 80%. Acceptable values are: Mean (+/-) 5% of reference value (80.75% - 89.25%); and %C.V. < 5% (Actual CV = 2.25%). All within acceptable ranges.
Intra-lot reproducibility (Normal Sample, Factor II Deficient – Lot 1, CV%)	1.4%
Intra-lot reproducibility (Normal Sample, Factor II Deficient – Lot 2, CV%)	0.8%
Intra-lot reproducibility (Abnormal Sample, Factor II Deficient – Lot 1, CV%)	2.0%
Intra-lot reproducibility (Abnormal Sample, Factor II Deficient – Lot 2, CV%)	3.4%
Inter-lot reproducibility (Normal Sample, CV%)	1.3%
Inter-lot reproducibility (Abnormal Sample, CV%)	2.7%
Correlation with predicate device (R² value)	R² = 0.997
Normal donor study (95% Confidence Interval for Factor II activity)	92.7% - 133.5% (Based on a mean of 113.1% and SD of 10.195%). This establishes the normal reference range for the device.

2. Sample Sizes Used for the Test Set and Data Provenance

24-Hour Open Vial Stability: 5 samples per time point (0, 8, 24 hours), totaling 15 unique measurements for the summary statistics.
Intra-lot Reproducibility: 10 samples per lot for both normal and abnormal samples, for each of the two lots.
Inter-lot Reproducibility: 20 samples per lot for both normal and abnormal samples.
Correlation Study: 9 distinct sample types (normal, borderline, pathological, various factor deficiencies), with 2 results taken for each sample type for both the equivalent device and the predicate device, resulting in 18 measurements for each device.
Normal Donor Study: 21 donors.

The data provenance is retrospective, as the studies were conducted to support the 510(k) submission for an already developed device. The country of origin for the device manufacturer is Canada (Nova Scotia). The origin of the plasma used for the device is human.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" in the way one might for diagnostic imaging or clinical decision support systems. This device is a lab reagent, and its performance is assessed against established laboratory methodologies and reference materials. The "ground truth" here is implied by the accuracy of the assays and the known characteristics of the samples (e.g., "known reference plasma," "samples with factor II levels in the normal, borderline, and pathological ranges," "healthy male and female donors"). The experts involved would likely be skilled laboratory professionals performing the assays and interpreting results against biochemical standards. Their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. As a laboratory reagent, an adjudication method in the context of expert consensus or arbitration for results is not described. The results are quantitative measurements from lab instruments.

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 device is a laboratory reagent and not an AI-assisted diagnostic tool that would involve human readers or image interpretation. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a standalone reagent. Its performance is evaluated directly through its interaction with other laboratory reagents and samples in controlled assays (Prothrombin Time, Activated Partial Thromboplastin Time, Factor II assays). There is no "human-in-the-loop" performance in the sense of a diagnostic interpretation that needs human input for its direct output. The device itself performs its function as a substrate independently, with humans performing the assay.

7. The Type of Ground Truth Used

The ground truth is established through:

Biochemical/Physiological Reference Standards: Known reference plasma for Factor II activity.
Characterized Samples: Samples with known or defined levels of Factor II (normal, borderline, pathological) and other factor deficiencies.
Clinically Defined Samples: Samples from healthy donors to establish a normal range.
Comparison to Predicate Device: The predicate device serves as a benchmark for performance comparison.

8. The Sample Size for the Training Set

Not applicable. This is a laboratory reagent, not a machine learning model, so there is no "training set." The product is manufactured and then tested to ensure quality and performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Ask a Question

Ask a specific question about this device

Page 1 of 1