Search Results

The NexSite™ HD, Hemodialysis Step Tip Catheter for long term use (60cm) is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

NexSite™ HD Hemodialysis Step Tip Catheter for Long Term Use (60cm)

I apologize, but the provided text focuses on the FDA's 510(k) clearance letter for the "NexSite™ HD Hemodialysis Step Tip Catheter for Long Term Use (60cm)." This document confirms the substantial equivalence of the device to a legally marketed predicate device and outlines regulatory compliance requirements.

However, the document does NOT contain information about:

• Acceptance criteria for a study proving device performance. The FDA letter is a regulatory clearance, not a study report.
• Device performance data (sensitivity, specificity, accuracy, etc.).
• Details about a test set (sample size, provenance).
• Information on experts establishing ground truth or adjudication methods.
• Whether an MRMC or standalone study was done.
• The type of ground truth used.
• Training set details (sample size, ground truth establishment).

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about study design and results using only the information from the provided text. The document refers to a medical catheter, not an AI/software device that would typically undergo the kind of performance studies you're asking about (e.g., for sensitivity, specificity).

Ask a specific question about this device