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The Eagle Eye Gold catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Eagle Eve Gold ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Avanar F/X 2.9F Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Avanar catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Eagle Eye® Gold and Avanar® F/X catheters incorporate a cvlindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Eagle Eye® Gold and Avanar® F/X catheters utilize an internal lumen that allows the catheter to track over the 0.014" (0.36mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The Eagle Eye Gold catheter is introduced percutaneously or via surgical cut down into the vascular system.

The Eagle Eve® Gold and Avanar® F/X catheters may only be used with the Volcano s5 or Volcano s5i IVUS imaging systems and can also be used with Volcano VH IVUS system software v1.2 or higher. These catheters will not operate if connected to any other imaging system.

The provided 510(k) summary for the Eagle Eye® Gold IVUS Catheter and Avanar® F/X IVUS Catheter describes modifications to existing, cleared devices, rather than a new device requiring extensive clinical trials or performance studies against a specific set of acceptance criteria demonstrated through a standalone study of the device's diagnostic performance. Therefore, many of the typical acceptance criteria and study elements you've requested for AI/diagnostic devices are not applicable or explicitly stated in this type of submission.

This submission focuses on demonstrating substantial equivalence to predicate devices (Eagle Eye™ Gold IVUS Imaging Catheter cleared under K051337 and Avanar F/X 2.9F IVUS Imaging Catheter cleared under K000820). The core of the performance data revolves around the impact of a change in material for the Brachial and Femoral Marker Bands.

However, I will extract what information is available and explain why other requested details are not present.

Acceptance Criteria and Reported Device Performance

The document states:
"Applicable testing was performed in accordance with the Design Verification Plan including a risk analysis addressing the impact of modifications to the device and components. The test results indicate the revised product is comparable to the predicate device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."

This indicates that specific acceptance criteria were predetermined for the design verification tests, primarily related to the safety and functionality of the modified components, and for biocompatibility. However, the specific quantitative acceptance criteria and detailed performance metrics are not provided in this 510(k) summary. The "reported device performance" is summarized as being "comparable to the predicate device" and meeting biocompatibility criteria.

Study Details (as inferable from the document):

Due to the nature of this 510(k) submission (device modification, not a new diagnostic algorithm or AI), most of the requested details are not applicable or not provided.

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

   • Not Applicable / Not Provided. This submission is for modifications to existing IVUS catheters, primarily material changes. It does not describe a clinical study with a "test set" in the context of diagnostic performance evaluation for an algorithm. The "test set" would refer to engineering and biocompatibility tests on the device itself and its components.

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

   • Not Applicable / Not Provided. No "ground truth" establishment by experts for a diagnostic performance test set is mentioned. The assessment of "comparability" and "meeting acceptance criteria" would be done by engineers, quality control personnel, and toxicologists/biocompatibility specialists interpreting the results of the specific design verification and biocompatibility tests.

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

   • Not Applicable / Not Provided. No clinical diagnostic test set requiring expert adjudication is discussed.

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:

   • Not Applicable / Not Provided. This document concerns medical devices (IVUS catheters), not an AI-powered diagnostic algorithm or system that requires an MRMC study to evaluate human reader performance with or without AI assistance. This device provides images for human interpretation, but it does not incorporate AI for automated analysis or enhancement in the way an AI diagnostic device would.

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

   • Not Applicable / Not Provided. This is a physical medical device (catheter) for imaging, not a standalone diagnostic algorithm.

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

   • The "ground truth" here would pertain to the correctness of the engineering and biocompatibility test results, established by standardized test methods and accepted physicochemical or biological endpoints (e.g., cell viability for cytotoxicity, material integrity under stress, etc.). It's not a clinical diagnostic ground truth.

7. The sample size for the training set:

   • Not Applicable / Not Provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not Applicable / Not Provided. No training set is discussed.

In summary: This 510(k) submission for IVUS catheters demonstrates substantial equivalence after minor material modifications. The "performance data" discussed are primarily engineering and biocompatibility tests to ensure the changes do not negatively impact safety or effectiveness, not diagnostic performance studies common for AI or new diagnostic devices. Therefore, a direct mapping to many of your requested criteria for AI/diagnostic devices is not possible based on the provided text.

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