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The UNIFUSE Infusion System with Cooper Wire is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral and pulmonary artery vasculature.

The proposed UNIFUSE Infusion System with Cooper Wire devices are single-lumen, nylon catheters with longitudinal slits located at 90° intervals around the distal end of the catheter for fluid delivery. An occluding ball wire (or occlusion guidewire) provides end-hole occlusion during fluid delivery. The catheters are available in 4F and 5F diameters and overall lengths of 90cm and 135cm. Additionally, they are available in multiple infusion segment lengths, including 2cm, 5cm, 10cm, and 15cm lengths – the latter two of which are the subject of this proposal. It is also worth noting that the overall length of each catheter remains the same no matter the length of the infusion segment. The active infusion area can be identified under imaging by means of radiopague markers on the catheter shaft at the distal and proximal ends of the infusion segment.

The provided text describes the UNIFUSE Infusion System with Cooper Wire and the study conducted to demonstrate that proposed longer infusion segment lengths (10cm and 15cm) are substantially equivalent to previously cleared shorter lengths (2cm and 5cm) for use in the pulmonary artery vasculature.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document states that "multiple practicing physicians" participated in the human factors study. It does not specify the exact number of physicians or the number of tests performed.
• Data Provenance: The study was a "simulated-use vascular model" study. The provenance is internal testing performed by AngioDynamics, Inc. It does not specify the country of origin of the data beyond the company's address in Massachusetts, USA. The study is prospective in the sense that it was conducted specifically to evaluate the new configurations.

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

• Number of Experts: "multiple practicing physicians experienced in the use and placement of infusion catheters." The exact number is not provided.
• Qualifications of Experts: They were "practicing physicians experienced in the use and placement of infusion catheters." No further specific details like years of experience or sub-specialty (e.g., interventional radiology, cardiology) are given.

4. Adjudication Method for the Test Set:

• The document implies that the observed performance of the device by the physicians in the simulated environment was directly assessed against the criteria. There is no mention of a formal adjudication method (like 2+1 or 3+1 consensus) being used to establish a "ground truth" for the test results themselves. The "ground truth" (or the desired outcome) was the ability of the device to perform as intended and for the DFU to be adequate, which was observed and concluded by the study conductors.

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, an MRMC comparative effectiveness study was not done. This study is for a medical device (infusion system), not an AI-assisted diagnostic tool. The "human factors" testing involved physicians using the device on a simulated model, not "reading" cases with or without AI assistance.

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

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device (catheter system), not an algorithm. The human factors testing necessarily involved human operation of the device.

7. The Type of Ground Truth Used:

• The ground truth for the human factors study was essentially expert observation and assessment in a simulated environment. The "truth" being confirmed was the device's functional performance in the intended use environment (pulmonary artery vasculature) by experienced users (physicians). This includes the ability to navigate, place, use, and image the device.

8. The Sample Size for the Training Set:

• The concept of a "training set" is not directly applicable here as this is a physical medical device and a human factors study, not a machine learning model. Therefore, no training set was used in the context of the study described for the K202347 submission. The study aimed to demonstrate the performance characteristics of the physical device.

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

• Given that there was no training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and previous iterations (predicate device K192864) was established through a series of performance tests (listed in Table 2) covering various physical and functional aspects, along with human factors testing. For the current submission, the "ground truth" was established by comparing the performance of the new configurations to the established performance characteristics of the predicate device through the human factors study.

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