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CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor X deficiencies in in vitro clot-based factor X assays using the one stage prothrombin time.

CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits.

This document is a 510(k) clearance letter for the "CryoCheck Factor X Deficient Plasma" device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., with performance metrics like sensitivity, specificity, or accuracy compared to a ground truth).

The letter merely states that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The described "Indications For Use" explain how the device functions to assess factor X deficiencies but do not provide performance metrics or details of a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a scientific study report or clinical trial summary.

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