Search Results

The NexSite HD, Hemodialysis 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.

The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement. The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.

The provided text describes a medical device, the NexSite™ HD Hemodialysis Catheter, and its 510(k) submission for regulatory clearance. It details the device's intended use, comparison to predicate devices, and the testing performed. However, it does not contain the kind of information typically associated with acceptance criteria and study results for an AI/device performance study as described in your request.

The document pertains to a physical medical device (catheter) and focuses on demonstrating substantial equivalence to already marketed devices through in vitro and in vivo (animal, not human clinical) testing, rather than a study evaluating the performance of an AI algorithm or digital medical device.

Therefore, many of the requested fields cannot be filled. I will fill in what information is available based on the provided text, and explicitly state when information is not present.

Acceptance Criteria and Study for NexSite™ HD Hemodialysis Catheter

The document describes the testing performed for the NexSite™ HD Hemodialysis Catheter to demonstrate its safety and effectiveness for substantial equivalence, rather than setting distinct acceptance criteria for an AI algorithm's performance. The "acceptance criteria" here are implied by meeting the requirements of applicable standards and demonstrating substantial equivalence to predicate devices through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as numerical sample sizes for each test in the provided text. The document refers to "finished NexSite™ HD devices" and "commercial predicate devices" being tested.
• Data Provenance: The "in vivo implantation studies" suggest animal studies, not human data. The in vitro testing was performed on the device itself. Specific country of origin for the data is not mentioned beyond the manufacturing location (Ireland) and the regulatory submission to the FDA (USA). The studies were conducted specifically for the purpose of this 510(k) submission (prospective, in the context of device development and regulatory clearance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. This device does not involve expert-established ground truth in the context of diagnostic AI. The "ground truth" for its performance is determined by physical and biological testing against established standards and predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not mentioned. This concept is not relevant to the type of device testing described.

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 or imaging device that would involve human readers.

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

• Not applicable. This is a physical medical device, not an algorithm. The testing described is "standalone" in the sense that it evaluates the physical performance of the device without human interaction in the performance metrics, but it is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" for this device is based on engineering standards (ISO 10555-1:2004) for in vitro tests, and biological/physiological performance in animal models for in vivo tests, demonstrating the device performs "as intended" and is substantially equivalent to predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI model.

Ask a specific question about this device