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The 12F Tri-Flow Triple Lumen Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. The 12F Tri-Flow Triple Lumen Catheter is intended to be used less than (30) days.

The 12F Tri-Flow Triple Lumen Catheter is a short term dialysis catheter made of thermosensitive polyurethane. The catheter has three separate lumens allowing continuous blood flow. The venous (blue) and arterial (red) lumens may be used for hemodialysis and apheresis treatments. The middle (clear) lumen is independent from the two dialysis lumens, and may be used for intravenous therapy, blood draws and infusion of medications.

The provided text describes a 510(k) premarket notification for a medical device, the "12F Tri-Flow Triple Lumen Catheter." It focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or performance data akin to what would be provided for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study based on AI or CADe functionality cannot be extracted from this document, as the document details a traditional medical device submission based on comparison to a predicate device and bench/non-clinical testing.

The document's "Bench/Performance Data/Non-Clinical Testing" section (page 5-6) lists various ISO and ASTM standards and the "Performance Testing" conducted against them. These are primarily related to the physical, chemical, and biological properties of the catheter, such as:

• Air Leak, Catheter Leak, Extension-Hub, Extrusion-Hub, Gravity Flow (against ISO 10555-1)
• Shipping and Shelf Life testing (against ISO 11607-1, ISO 11607-2)
• Gauging (against ISO 594-1)
• Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding Stress Cracking (against ISO 594-2)
• Biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility against ISO 10993 series and USP/OECD guidelines).

These are not "device performance" in the context of an AI-powered diagnostic or therapeutic device where sensitivity, specificity, accuracy, or human reader improvement are measured.

In summary, none of the specific questions regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth for an AI/CADe device performance study can be answered from the provided text. The document pertains to a K181175 submission for a physical medical device (catheter) based on substantial equivalence and non-clinical bench testing.

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