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The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is used for clinical laboratory testing in chemistry and for the monitoring of certain therapeutic drugs.

BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes are sterile blood collection tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Serum Separator (SST™) Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant. 3) an inert polymer separator gel, and 4) a clot activator.

The provided text is a 510(k) premarket notification for a medical device, specifically a blood collection tube. It details the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

However, the questions you've posed (related to acceptance criteria and studies proving the device meets them, particularly pertaining to AI/algorithm performance, expert ground truth, MRMC studies, training/test set sample sizes, etc.) are not covered in this document. This document describes the regulatory submission for a physical medical device (blood collection tube) and focuses on its physical and chemical performance, sterility, shelf-life, and clinical equivalence for its intended use in collecting and processing blood samples for in vitro diagnostic testing.

There is no mention of any AI component, algorithm, or software in this submission. Therefore, it's impossible to extract information about:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample sizes for AI test sets or data provenance
• Number/qualifications of experts for AI ground truth
• Adjudication methods for AI test sets
• MRMC studies for AI assistance or standalone AI performance
• Type of ground truth for AI (pathology, outcomes data, etc.)
• Training set sample size for AI
• How ground truth for AI training was established

In summary, the provided document does not contain the information required to answer your specific questions, as those questions are relevant to the regulatory clearance of AI/Software as a Medical Device (SaMD), not a physical blood collection tube.

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