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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 Eye 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.

Volcano VH IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH IVUS System is intended to semiautomatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular featues that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The Eagle Eye catheter incorporates a cylindrical 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 realtime images of the coronary and peripheral vessels.

The Eagle Eye™ Gold catheter utilizes 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 Eye Gold catheters may only be used with the In-Vision™ Imaging System using v4.2 software or higher or v4.2 VH software or higher and can also be used with Volcano VH IVUS System software v1.2 or higher. This catheter will not operate if connected to any other imaging system.

The Volcano VH IVUS (VI) System is a combination of proprietary hardware and The Volcano VTTVOO (VT) Oyetem or device to In Vision Gold, a conventional soltware. The System is an accovice in the peripheral and coronary vasculature.

The hardware portion consists of a high-speed computer placed on-board the In The hardware portion concluding built for use in medical institutions; high-speed vision Gold oonversion circuitry and proprietary gating circuitry. The system analog-to-aighter on onvolon-ell-sallify is system and the ECG system using typical is connootou to the estiofrequency output is used directly by the Volcano IVUS Cabiling. THE IVOO factor series of time the collection / recording of the IVUS signal.

The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System comprises a data acquisition module and a data analysis volule. The data acquisition module communicates with the analog-to-digital moudle: The data as a manages the joining of the data from individual scans on volule in clice". The data analysis module analyzes each of the slices. that conomate are visually reviewed, a segment for analysis is selected, and vessel inner and outer borders are identified. The black and white IVUS files are vooses innor and oute the five color bit-mapped Volcano IVUS image files.

The provided 510(k) summary for the Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria as would be expected for a novel device.

The document states:
"Performance Data: Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. Results met the predetermined acceptance criteria."

However, it does not provide any specific acceptance criteria or the details of the study performed or its results. Instead, it relies on the premise that the device's fundamental scientific technology and intended use are the same as its predicate devices, and that modifications do not raise new questions of safety or efficacy.

Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

Information Not Provided. The document mentions "Applicable testing was performed" but does not detail the nature of this testing, the sample size of any test sets, or the provenance of any data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Information Not Provided. As there is no detailed description of a specific performance study or ground truth establishment, this information is absent. The device is for "evaluation of vascular morphology," implying clinical assessment, but no details on expert involvement for validation are given.

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

Information Not Provided. No details on adjudication methods for any test set are mentioned.

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

Information Not Provided. This document dates to 2005 and describes an IVUS catheter and system. While the Volcano VH IVUS System is described as intending to "semiautomatically visualize boundary features and perform spectral analysis," this predates the common use of the term "AI" in medical device submissions for advanced image analysis. There is no mention of an MRMC study or an effect size for human reader improvement with or without AI assistance. The focus is on the device itself providing images and semi-automatic analysis.

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

Information Not Provided. The document describes a system with "semiautomatically visualize boundary features" and "perform spectral analysis," suggesting some algorithmic function. However, it does not state whether a standalone performance evaluation of just these algorithms was conducted, independent of a human-in-the-loop scenario. The context implies it's an adjunct to angiography and for diagnostic imaging examinations where a user would be involved.

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

Information Not Provided. The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

Information Not Provided. No information on a training set or its size is present. This is relevant for "AI" or machine learning systems, but the document's description of "semiautomatically visualize boundary features" and "perform spectral analysis" does not explicitly detail an AI/ML component that would require a distinct training set in the modern sense.

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

Information Not Provided. As no training set is described, there's no information on how its ground truth would have been established.

In summary: The 510(k) summary for the Eagle Eye™ Gold IVUS Catheter/Volcano VH IVUS System is a substantial equivalence submission. It states that "Applicable testing was performed... Results met the predetermined acceptance criteria," but it does not disclose the specific acceptance criteria, the details of the performance study, any sample sizes, data provenance, expert qualifications, adjudication methods, or specific performance metrics. The focus is on demonstrating equivalence to previously cleared predicate devices based on fundamental scientific technology and intended use, rather than presenting a detailed performance study against specific acceptance criteria for a novel device function.

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