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Cryov Check™ Factor XI Deficient Plasma is recommended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT).

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

The provided text describes the 510(k) summary for CryoCheck™ Factor XI Deficient Plasma, focusing on its non-clinical performance data for open vial stability.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): 5 samples at 0 hours and 5 samples at 24 hours (total of 10 measurements for summary statistics).
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, it's a non-clinical performance test conducted by the manufacturer, Precision Biologicals Incorporated, located in Dartmouth, Nova Scotia, Canada. The study appears to be prospective as it involves specifically testing the device's stability over time.

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 text. The "ground truth" here is the "known reference plasma" to which the Factor XI assays are compared, but details about its establishment or expert involvement are absent. The test is comparing the device's performance to a "known reference plasma," implying an established standard, but no human expert consensus process is described for this specific test.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• This information is not applicable to this type of non-clinical performance study. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where discrepancies among evaluators need to be resolved. This study focuses on objective measurements of Factor XI recovery.

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

• This information is not applicable. This is a non-clinical performance study for an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers or interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This information is not applicable. This device is a reagent for laboratory testing; it does not involve algorithms or AI in the way implied by "standalone performance."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for this test is a known reference plasma. The Factor XI assays were performed on this reference plasma, and the "recovered factor XI values" using the CryoCheck™ Factor XI Deficient Plasma as a substrate were compared to it. The "reference value" is also implied as the basis for the acceptance criteria "Mean (+/-) 5% of reference value."

8. The sample size for the training set

• This information is not applicable. The device is a diagnostic reagent, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• This information is not applicable for the same reasons as point 8.

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