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The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

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This document is a 510(k) premarket notification for a medical device, specifically a "S-Monovette EDTA K2-Gel" blood collection tube. It outlines the FDA's decision regarding substantial equivalence to a predicate device and provides information on the intended use of the device.

However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations of AI/ML-driven or diagnostic/screening devices for which the requested information (e.g., sample size for test set, number of experts, adjudication method, AI vs. human performance) would be relevant.

This document pertains to a blood specimen collection device, which is a Class II medical device. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness through comparisons of design, materials, performance, labeling, and intended use. Performance testing for a blood collection device would typically involve demonstrating its ability to properly collect, store, and process blood specimens according to its stated indications, and to ensure the blood components (e.g., plasma) are suitable for subsequent laboratory testing. This would involve chemical stability, sterility, and physical integrity studies rather than diagnostic accuracy studies with ground truth.

Therefore, I cannot extract the requested information (Table of acceptance criteria, sample size, expert qualifications, etc.) because it is not present in this type of FDA 510(k) summary for a blood collection device. The information requested is more relevant for diagnostic devices that analyze patient data to make a clinical determination.

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