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The DermaPort Ported Vascular Access System (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.

The Ported Vascular Access System (PVAS™) has been developed to support central vascular access for hemodialysis and apheresis. This application is for the addition of a 15.5F catheter to the PVAS system and a dilating lead-in to replace the sheath during insertion. The PVAS port consists of a percutaneous tubular conduit, through which a standard 14.5F or 15.5F polyurethane hemodialysis catheter enters the subcutaneous tunnel. An integral seal surrounds the catheter and prevents microbial migration along the catheter. The PVAS port is enclosed by a silicone anchor that braces the assembly to the skin, and an associated brake holds the catheter in place within the port. A tissue integrating biomaterial surrounds the port, providing anatomical fixation and prevention of microbial migration in a manner analogous to the Dacron cuff of a tunneled catheter.

The provided text describes a 510(k) premarket notification for a medical device called the DermaPort Ported Vascular Access System (PVAS™). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format of a diagnostic or AI-driven device.

Therefore, many of the requested elements for a diagnostic device study description (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets) are not applicable or available in this type of regulatory submission.

The "acceptance criteria" here are implicitly related to the safety and functionality of the physical device modifications remaining within acceptable limits compared to the predicate, as evidenced by various engineering and animal tests, rather than diagnostic performance metrics.

Here is the information that can be extracted and a clear indication of what is not available based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device (physical medical device, not a diagnostic algorithm) are typically focused on engineering and functional specifications, material compatibility, and biological safety. The "reported device performance" refers to the verification that these specifications are met following modifications. Specific numerical thresholds (e.g., for safety margins, flow rates, or biomechanical strength) are not detailed in this summary.

Study Details (Information Not Applicable or Available in the Provided Text)

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. This document describes engineering and animal studies for device modifications, not a clinical diagnostic performance study. Specific sample sizes for each test (insertion, histopathology, biomechanical, retention, microbial ingress, flow-pressure, biocompatibility) are not provided. The chronic animal model mentioned implies prospective animal testing, but details are absent.

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

   • N/A. This device is a physical medical device, not an AI or diagnostic tool requiring ground truth established by human experts in the conventional sense. Material and engineering standards/experts would be involved in defining test methods and interpreting results, but not in setting "ground truth" for a diagnostic test set.

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

   • N/A. Not applicable to the type of device and studies described.

4. 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:

   • N/A. This is not an AI-assisted diagnostic device.

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

   • N/A. This is a physical medical device, not an algorithm.

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

   • N/A (in the diagnostic sense). For this device, ground truth would be defined by engineering specifications, material standards, physiological parameters in animal models (e.g., successful tissue ingrowth in histopathology), and regulatory safety requirements. It's not "ground truth" for a diagnostic decision.

7. The sample size for the training set:

   • N/A. This device does not use a "training set" in the context of machine learning or algorithms. The studies are for design verification and validation of physical modifications.

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

   • N/A. As above, no training set or ground truth in this context.

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