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Indicated use - Factor deficient plasma, Factor - VII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Factor deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.

This document does not contain information about acceptance criteria, device performance, or a study that evaluates a device against acceptance criteria in the way described in the prompt. The document is a "Non-Confidential Summary of Safety and Effectiveness" for "Factor deficient coagulation plasma - VII." It primarily serves to compare the intended product with predicate devices.

Here's a breakdown of why the requested information cannot be extracted:

• No defined acceptance criteria: The document lists "Performance Testing" attributes, but these are general characteristics (e.g., "Compare assay to known sample," "Deficiency of relevant factor less than 1%") rather than specific, quantitative acceptance criteria with thresholds.
• No reported device performance against criteria: While it states "Yes" for the intended product meeting certain characteristics, it doesn't provide numerical or qualitative results from a study demonstrating performance against specific, pre-defined acceptance criteria.
• No study details: The document mentions "Performance Testing" but does not describe a study. There is no information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods. The "Performance Testing" section simply lists features the device will possess or is designed to meet, not the results of a test proving it.
• AI/Human-in-the-loop irrelevance: This document describes a diagnostic reagent, not an AI or imaging device, so questions related to MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable.

Therefore, it is not possible to fill out the requested table and answer the study-related questions based on the provided text.

The document's purpose is to argue substantial equivalence to predicate devices, focusing on design features and intended use rather than presenting a performance study against acceptance criteria.

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