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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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