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The Volcano s5i Family of Imaging Systems is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

ChromaFlo® is indicated for qualitative blood flow information from peripheral and coronary vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The Volcano s5i Family of Imaging Systems consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays highresolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5i Imaging Systems can be an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® a twodimensional color map of relative blood flow is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital option displays a twodimensional, 360 rotations and longitudinal view of the Volcano s5i Imaging System software provides an option for connectivity with third party fluoroscopic imaging systems. The software option simplifies the Cardiac Catherization Lab workflow with the fluoroscopic imaging systems by, 1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes, etc.) from the fluoroscopic imaging system with the Volcano s5i Imaging System, 2) providing a remote access to commonly used IVUS functions from the fluoroscopic imaging system user interface.

The imaging catheters are all marketed under separate premarket notifications; Visions catheter K982329, Avanar catheter K000820 and Eagle Eye Gold K031346.

The provided text does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance verification documents.

This document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. While it mentions "Performance Data," it does not elaborate on the specifics of this data.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to "test plans and protocols" but does not detail their contents or the pass/fail criteria.
• Reported Device Performance: Not explicitly stated. The document only generically says, "The test results were found to be acceptable as required by the respective test plans and protocols," without providing any quantitative or qualitative performance metrics.

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

• Sample Size: Not mentioned.
• Data Provenance (Country of origin, retrospective/prospective): Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• Was it done? Not mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on a new comparative effectiveness study with human readers.
• Effect size of human readers with AI vs. without AI assistance: Not applicable as no MRMC study is reported.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

• Was it done? The document describes the "Volcano s5i Family of Imaging Systems" as consisting of "the imaging catheter, the patient interface module, and the system console," implying an integrated system. The "ChromoFlo®" feature provides an "overlaid" color map, suggesting it's part of the system's output. While performance data was collected, it's not specified if this was for the algorithm alone in a standalone capacity without a human interpreting its output. Given the nature of an imaging system, direct "standalone" algorithm performance for diagnosis in isolation from a human reader is less typical for a 510(k) unless AI is providing a direct diagnosis. The document does not describe such a standalone AI diagnosis.

7. The Type of Ground Truth Used:

• Not mentioned.

8. The Sample Size for the Training Set:

• Not mentioned. (It's unclear if machine learning/AI was a primary component requiring a 'training set' in the modern sense for this specific 510(k), as the submission predates widespread AI-as-medical-device submissions. The "ChromoFlo" aspect might involve some signal processing or algorithmic work, but traditional "training sets" for deep learning weren't standard practice for 510(k)s of this era.)

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

• Not mentioned.

In summary, the provided 510(k) Summary is a high-level document confirming the safety and effectiveness of a modified device through substantial equivalence. It lacks the specific details regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement that would be present in a comprehensive performance study report or clinical trial documentation. The document explicitly states: "Applicable testing was performed to evaluate the modifications to the Volcano s5i Family of Imaging Systems. The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that internal testing was conducted, but the specifics of those tests are not disclosed in this public summary.

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