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The NexSite HD Hemodialysis Step Tip Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are indicated for femoral vein insertion.

The proposed device, the NexSite HD Hemodialysis Step Tip Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The proposed device is available in the following models below and has a Dacron cuff distal to the bifurcation hub.

Models:

NexSite HD Hemodialysis Step Tip Catheter for long term use (24cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (28cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (32cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (36cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (40cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (55cm)

A Dermal Ingrowth Support Collar (DISC), manufactured from polyurethane and Dacron®. and supplied with the Catheter, is implanted subcutaneously, and is intended to assist with the direction of the catheter. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, and Luer Caps) that are used to facilitate catheter placement.

The NexSite HD Hemodialysis Step Tip Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. It is a blood contact device with greater than 30 days of exposure.

The provided text describes a 510(k) premarket notification for a medical device, the NexSite™ HD Hemodialysis Step Tip Catheter. It outlines the device, its intended use, comparison to predicate devices, and performance data. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the format typically used for AI-driven software or diagnostic tests.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a combination of in vitro and in vivo testing. The acceptance criteria mentioned are general, pertaining to the requirements in applicable standards and specifications for the catheter's physical and functional properties, rather than performance metrics related to an algorithm's output.

Here's an attempt to answer your questions based on the provided text, recognizing that it's for a physical device, not an AI or diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria and reported numerical device performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC with associated thresholds). Instead, it states that the device "meets the requirements in the applicable standards and specifications."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests. The document mentions "finished proposed NexSite™ HD Step Tip catheters" were used for comparative performance testing, and "in vivo implantation studies were also performed." The exact number of catheters or animal subjects is not provided.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing ("In vitro testing was performed on the NexSite HD Hemodialysis Step Tip Catheter"). The in vivo studies were also performed to demonstrate the device would perform as intended, but details on their nature (e.g., animal or human, retrospective or prospective) are lacking, though the context suggests animal models for a physical device before human use. Given it's a 510(k) for a physical device, no "data provenance" in the clinical data sense is typically required beyond the testing performed to demonstrate substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the provided document. The "ground truth" for this medical device (a catheter) is based on engineering specifications, material properties, and biological compatibility standards, not on expert interpretations of data like in an AI diagnostic. The safety and effectiveness are evaluated against these standards and through performance testing, not through expert consensus on diagnostic labels.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described as would be for a diagnostic or AI system. The tests are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device for diagnostic interpretation. It is a physical medical device (catheter).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters — Part 1: General requirements).
• Adherence to internal specifications derived from the design and intended use of the catheter, and comparison to legally marketed predicate devices.
• Results from in vitro and in vivo studies demonstrating functional performance and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device.

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