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The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is indicated for short-term (up to 30-days) access to the central venous system for intravenous therapy, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of power injector equipment used with the Arrow Pressure Injectable JACC with Sustain Technology may not exceed 300 PSI. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology is a single-use catheter intended for percutaneous insertion over a guidewire to facilitate access to the central venous system. The device is intended for short term use (up to 30 days) and is provided sterile in a convenience kit configuration which includes single-use accessories to facilitate the insertion procedure. These accessories may include, but are not limited to; introducer needles, guidewires, tissue dilators, and catheter securement devices. The Arrow Pressure Injectable JACC with Sustain Technology features a radiopaque polyurethane catheter body with a soft, tapered distal tip. The device design is summarized as follows: Catheter Body OD: 6 French, Lumens: 3, Catheter Body Length: 20 cm. The proximal end of the catheter includes extension lines with integral Luer hubs to facilitate access to the catheter body lumens for infusion and aspiration. The distal lumen of the Arrow Pressure Injectable JACC with Sustain Technology is compatible with power injection flow rates up to 6 ml /sec and pressures up to 300 PSI. The full-length of the outer surface (and partial length of the internal lumen surface) of the Arrow Pressure Injectable JACC with Sustain Technology is modified with a biomimetic polymer technology. The "Sustain" polymer surface modification technology is intended to reduce platelet adhesion and thrombus accumulation.

This document describes the regulatory submission for the Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (K150109). The information provided focuses on non-clinical performance data to support substantial equivalence, rather than a clinical study with detailed acceptance criteria for an AI device. As such, several requested items regarding AI device performance (effect size of human readers with/without AI, standalone AI performance, sample sizes for training/test sets, ground truth establishment for training set, adjudication methods, and expert qualifications for ground truth) cannot be directly extracted from this document, as it pertains to a medical device approval that does not involve an AI component.

However, I can provide the available information regarding the device's performance, acceptance criteria (as performance verification tests), and the study conducted.

1. A table of acceptance criteria and the reported device performance:

Since this is a medical device, the "acceptance criteria" are the performance requirements met through various bench and in vitro tests, as well as an in vivo animal study. The reported performance is the successful completion of these tests, demonstrating the device's functionality and safety. The document states that the results "support substantial equivalence."

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

• Test set for in vitro Platelet Adhesion: The document does not specify a numerical sample size (e.g., number of catheters tested). It mentions a "paired analysis of in vitro measurements" and implies a comparison between the Sustain JACC and an untreated polyurethane catheter.
  • Data provenance: In vitro testing. "In vitro testing was conducted in a 1-2 hour flow loop utilizing bovine blood."
• Test set for in vivo Animal Testing: The document does not specify a numerical sample size but mentions "an ovine model" and "a randomized, controlled study." This refers to sheep as the animal model.
  • Data provenance: In vivo animal study in an ovine (sheep) model.

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

This information is not applicable. The studies described are non-clinical (bench and animal studies) for a medical device, not a human clinical study or an AI diagnostic study that would involve expert interpretation to establish ground truth.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations involving human readers. The documented studies are lab-based performance tests and an animal study.

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:

No. This was not an MRMC comparative effectiveness study, nor did it involve AI. The device is a physical catheter, not an AI-powered diagnostic tool.

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

No. This question pertains to AI algorithm performance, which is not relevant to this medical device submission.

7. The type of ground truth used:

• For in vitro Platelet Adhesion: The "ground truth" was the direct measurement of radio-labeled platelet adhesion on the catheter surface compared to an untreated control. This is a direct physical/biological measurement.
• For in vivo Animal Testing: The "ground truth" was established by direct observation and measurement in the ovine model, including:
  • In-life catheter patency (observed function)
  • Post-mortem vessel patency scores (direct examination)
  • Post-mortem device thrombus scores (direct examination)
  • Post-mortem thrombus weight (direct measurement)
  • Safety endpoints (adverse events, gross pathology, and histopathology, assessed by veterinary pathologists/researchers).

8. The sample size for the training set:

This information is not applicable. There is no AI component, and thus no training set in the context of machine learning.

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

This information is not applicable for the same reason as point 8.

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