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The Volcano 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 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 the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm.

The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures.

The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323.

Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.

This FDA 510(k) submission describes the Volcano s5/s5i/CORE/CORE Mobile Precision Guided Therapy System and focuses on a change in the Indications for Use for its iFR Modality. The submission aims to adopt a new, single diagnostic cut-point for iFR guided revascularization based on recent clinical evidence, replacing a previous 'hybrid' approach.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here re-frame the iFR Modality's diagnostic cut-point. The previous approach was likely a range (e.g., 0.75-0.80), and the new acceptance criteria is a single, dichotomous cut-point of 0.89. The device performance is evaluated against this new cut-point in terms of its clinical outcomes compared to FFR guidance.

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" for this submission are the patient cohorts from the three clinical studies cited:

• ADVISE II: The document does not explicitly state the total sample size for ADVISE II but mentions a C-statistic and confidence interval, indicating a substantial number of patients. It is a "[P]rospective Assessment," implying prospective data. As it's an "International, Multicenter Study," the data provenance is likely multi-country.
• DEFINE-FLAIR: Enrolled 2492 patients with coronary artery disease. Data provenance is prospective and multi-country/international (implied by nature of trials with such large patient cohorts).
• iFR-SWEDEHEART: Enrolled 2017 patients with coronary artery disease. Data provenance is prospective and primarily from Sweden (all 30 coronary intervention centers in Sweden plus one site in Iceland).

All data presented are from prospective, randomized controlled clinical trials or prospective diagnostic accuracy studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not specify the number or qualifications of experts directly involved in establishing the "ground truth" for the test sets within these studies. Instead, the ground truth is established by:

• FFR (Fractional Flow Reserve): This is the comparative "gold standard" for assessing lesion severity and guiding revascularization. FFR values themselves are physiological measurements, not interpretations by experts in the same way as imaging reads.
• Clinical Outcomes: The primary endpoint of the DEFINE-FLAIR and iFR-SWEDEHEART studies was a composite of "all-cause mortality, non-fatal myocardial infarction or unplanned revascularization." These are objective clinical events, not subject to expert interpretation for ground truth.

Therefore, the "ground truth" is based on established physiological measurements (FFR) and objective clinical endpoints, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the context of expert review. Since the ground truth for the comparative studies (DEFINE-FLAIR, iFR-SWEDEHEART) was FFR measurements and objective clinical outcomes, traditional adjudication by a panel of readers is not applicable in the same way it would be for an AI-based imaging diagnostic. For the ADVISE II study, which focused on the diagnostic accuracy of iFR against FFR, the "ground truth" for comparison was the FFR value, not expert consensus. Clinical events in the RCTs would typically be centrally adjudicated by a clinical events committee (CEC), but details of such adjudication are not provided in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of Human Reader Improvement with AI vs. without AI assistance

No, a traditional MRMC comparative effectiveness study was not performed as described for an AI device. This submission is for a change in the indications for use of a measurement modality (iFR) used by a human operator, not an AI interpreting images or assisting human readers. The "comparison" is between guiding revascularization with iFR vs. FFR, not human performance with or without AI.

The "effect size" is demonstrated by the non-inferiority of iFR-guided revascularization to FFR-guided revascularization for clinical outcomes, and the significant reduction in adverse effects due to iFR not requiring adenosine.

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

The iFR Modality is essentially a "standalone algorithm" in terms of its calculation of the iFR value itself. However, it's always "human-in-the-loop" in its clinical application – the iFR value is provided to a physician who then uses it to make treatment decisions. The studies presented (DEFINE-FLAIR, iFR-SWEDEHEART) are comparisons of clinical decision-making strategies (iFR-guided vs. FFR-guided), which inherently involve human decision-makers using the device.

7. The Type of Ground Truth Used

The primary ground truth used for proving the device's efficacy in guiding revascularization was:

• Clinical Outcomes Data: This is the most significant ground truth (all-cause mortality, non-fatal MI, unplanned revascularization).
• FFR (Fractional Flow Reserve): Used as the comparative gold standard for assessing lesion hemodynamics and as the basis for clinical decision-making in the control arms of the studies. The ADVISE II study specifically evaluated iFR's diagnostic accuracy against FFR.

8. The Sample Size for the Training Set

This submission does not discuss a "training set" in the context of machine learning. The device is a physiological measurement system, and the change being applied is based on new clinical evidence supporting a revised interpretation/cut-point for an existing measurement. The clinical studies (ADVISE II, DEFINE-FLAIR, iFR-SWEDEHEART) serve as the evidence base for this updated interpretation, rather than a training set for an AI model.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" in the AI sense for this device, this question is not directly applicable. The "ground truth" supporting the revised iFR cut-point in this context comes from the results of large-scale, prospective, randomized controlled clinical trials (DEFINE-FLAIR, iFR-SWEDEHEART) demonstrating non-inferiority of iFR-guided care to FFR-guided care and the diagnostic accuracy study (ADVISE II) correlating iFR to FFR values.

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The CORE M2 Vascular System is used for the qualitative 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 CORE M2 Vascular 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. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional grayscale image.

In addition to producing grayscale IVUS images, the CORE M2 System with Software v4.2 provides the ChromaFlo feature which can be used to identify blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity on to the grayscale ultrasound image.

The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.

The provided document, a 510(k) summary for the CORE M2 Vascular System Software v4.2, describes several verification and validation activities. However, it does not include detailed acceptance criteria or a specific study that quantifies device performance against those criteria in the typical format of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating that the software modifications maintain substantial equivalence to a predicate device. The performance data presented are primarily engineering and system-level validations, as well as qualitative assessments of clinical acceptability.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide a quantitative table of acceptance criteria and reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm. Instead, the performance data focuses on system functionality and image quality.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not specified for any of the validation steps. The document refers to "testing" without providing numerical sample sizes for cases, images, or subjects.
• Data Provenance: Not specified. It's unclear if the data used for image validation or acoustic output comparison was from a specific country or if it was retrospective or prospective. Given the nature of a 510(k) for software updates to an existing system, it's likely previous data and newly acquired bench/phantom data were used.

3. Number of Experts and their Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document mentions "clinically acceptable for end users" in the Image Validation section, implying clinical assessment, but the details of who performed this or their qualifications are absent.

4. Adjudication Method for the Test Set

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not performed or reported in this summary. The device, the "CORE M2 Vascular System Software v4.2," including its "ChromaFlo" feature for qualitative blood flow information, is not presented as an AI-assisted diagnostic tool that augments human interpretation in a comparative effectiveness setting. It's a system for image acquisition and display, with ChromaFlo providing a visual depiction of blood flow.

6. Standalone (Algorithm Only) Performance Study

No. The document describes system-level validations and image quality assessments, but not a standalone performance study of an AI algorithm in the typical sense (e.g., measuring its diagnostic accuracy independently). The ChromaFlo feature is part of the system and provides "qualitative blood flow information" as an "adjunct to other methods," suggesting it's not intended for standalone diagnostic interpretation.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance (e.g., pathology, outcomes data) is not directly addressed in this document. The validations are more about:

• Engineering specifications ("meets specifications").
• Equivalence to a predicate device ("substantially equivalent").
• Meeting user needs ("meets user needs").
• Clinical acceptability ("clinically acceptable for end users").

For the "Image Validation" and "Simulated Use/Usability Validation," the "ground truth" would be the subjective judgment of clinical acceptability and usability by qualified individuals (though not specified). For acoustic output, it would be measured physical properties compared to established standards or the predicate.

8. Sample Size for the Training Set

Not applicable/Not specified. This document is about software modifications to an existing device, including the addition of a feature (ChromaFlo). It does not describe the development or training of a de novo AI algorithm with a distinct training set. The ChromaFlo feature uses "patented technology to provide a visual depiction of blood flow velocity," implying a predefined method rather than a machine learning model requiring a training dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm appears to have been used in the context of this 510(k) submission for software updates.

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