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The Volcano s5/s5i Series Intravascular Imaging and Pressure System 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.

VH IVUS 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 semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures.

Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.

When operating in IVUS mode, the system console gathers and displays high-resolution intraluminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the Volcano s5/s5i system is an adjunct to interventional therapies, such as balloon angioplasty. With ChromoFlo® (not available with Revolution catheter), a two-dimensional color map of relative blood velocities is overlaid on the grayscale image, providing additional information for vessel analysis. The In-Line Digital feature displays a two-dimensional, longitudinal view of the vessel. The angle of the longitudinal cut can be varied around the full 360 degrees.

When operating in pressure mode, the system acquires intraluminal data from the pressure guidewire (SmartWire II/ComboWire) while simultaneously taking aortic pressure data from the established ECG/EKG catheterization lab equipment. In conjunction with the procedure, the system measures pressure and calculates pressure differences between the aoritic pressure and the SmartWire/ComboWire pressure transducer typically located distal to the vascular lesion and calculates the fractional flow reserve (FFR).

The provided text is a 510(k) Summary for the Volcano s5/s5i Series Intravascular Imaging and Pressure System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to establish performance against acceptance criteria.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test and training sets, expert qualifications, or adjudication methods. The "Performance Data" section explicitly states that "A risk analysis was conducted... Applicable testing was performed as required by the Quality System to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates that verification and validation testing was performed internally according to established quality system procedures, but the specifics of those tests and their results against quantitative acceptance criteria are not included in this summary document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The document mentions that "test results were found to be acceptable as required by the respective test plans and protocols," but it does not provide the specific acceptance criteria or the reported device performance measurements for any of its features (IVUS, ChromaFlo, VH IVUS, Pressure, Rotational 45MHz).

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

• Missing. The document does not describe any specific clinical or bench test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are based on substantial equivalence to predicate devices and internal verification/validation testing.

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

• Missing. No information on experts or ground truth establishment for a test set is provided.

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

• Missing. No information on adjudication methods is provided.

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:

• Missing. This device is an imaging and pressure system, not an AI-assisted diagnostic tool in the sense of a software algorithm interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Missing. This device is a hardware system with integrated software; the concept of a "standalone algorithm" performance as typically understood for AI/CAD devices doesn't apply directly here. The system's functionalities (IVUS, pressure measurement, etc.) rely on the device hardware and software working together to produce data for human interpretation.

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

• Missing. As no specific performance study against a ground truth is described, this information is not available.

8. The sample size for the training set:

• Missing. No information about a training set is provided. The device likely uses algorithms that are well-established for intravascular ultrasound and pressure measurements, rather than machine learning models that require a distinct "training set" in the modern sense.

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

• Missing. As no training set is mentioned, the method for establishing its ground truth is also not provided.

What the document does state regarding performance evaluation:

• Performance Data: "A risk analysis was conducted according to 803475-001 Risk Management which was written to comply with ISO 14971 and IEC 60601-1-4 as specific risk management standards. Also taken into consideration in this procedure are 21 CFR 820.30 and the Medical Device Directive of the European Union (93/46/EEC). Applicable testing was performed as required by the Quality System to evaluate the modifications to the Volcano s5/s5i Intravascular Imaging and Pressure System. The test results were found to be acceptable as required by the respective test plans and protocols."
• Conclusion: "The discussion and data presented in this 510(k) and conformance with Design Controls and the Quality System Regulations establishes the Volcano s5/s5i Series Intravascular Imaging and Pressure System to be substantially equivalent for its intended use to the predicate devices listed in this submission."

In summary, this 510(k) focuses on demonstrating substantial equivalence based on the device's technological characteristics and intended use being similar to predicate devices, and internal validation testing compliant with quality system regulations. It does not provide the specific detailed performance study information typically found in submissions for novel diagnostic algorithms or AI-driven devices.

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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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In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated 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 vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel.

Here's an analysis of the provided text regarding the In-Vision™ Imaging System's acceptance criteria and studies:

Based on the provided 510(k) summary, the document does not contain specific acceptance criteria tables or detailed performance study results in the manner requested. The submission is a "Special 510(k)" for a software modification (version upgrade to V4.1) of an existing device. For such submissions, the focus is often on demonstrating that the changes do not raise new questions of safety or efficacy, rather than presenting extensive de novo performance data.

Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract the available information and highlight what is missing.

Acceptance Criteria and Device Performance

Not explicitly stated in the document. The document states: "Applicable testing was performed to evaluate the modifications to the In-Vision™ Imaging System. The test results were found to be acceptable as required by the respective test plans and protocols."

This indicates that internal acceptance criteria and protocols were used, but the specific metrics and performance values are not disclosed in this 510(k) summary.

Study Details (Based on Available Information)

Since detailed performance data is not provided, many of these sections will indicate "Not specified in document."

Summary of Information from the Document:

• Device Name: In-Vision™ Imaging System
• Purpose of Submission: Software modification (version upgrade to V4.1) to an existing intravascular ultrasound imaging system.
• Comparison: Claims substantial equivalence to predicate devices based on fundamental scientific technology, intended use, and clinical applications.
• Performance Data Statement: "Applicable testing was performed to evaluate the modifications... The test results were found to be acceptable as required by the respective test plans and protocols." This indicates internal testing was done and met predefined criteria, but the specifics are not public in this summary.
• Conclusion: The software modification "raises no new questions about safety and efficacy."

This 510(k) summary focuses on demonstrating that a software update to an already cleared device does not alter its fundamental safety or effectiveness profile, rather than providing a detailed performance study as might be expected for a novel device or an AI/ML product today.

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