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The iFR® 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 during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

New software feature have been added to the iFR Modality Live iFR and iFR Pullback that allow the assessment of a lesion (single cycle iFR measurement) or vessel (pullback measurement) in a resting condition without the requirement of a hyperemic agent. Both features, collectively referred to as the iFR® Scout allow the user to assess a length of vessel by placing the pressure sensor distally, record/measure, and pull the sensor back through the vessel to a stopping point. This generates a map of the wave-free pressure gradient iFR values along the vessel and a distal iFR value that represents the condition of the vessel at the most distal point of the recording.

The provided document is limited to an FDA 510(k) summary for the Volcano iFR Modality, iFR Scout Feature. This summary does not include detailed acceptance criteria, study methodologies, or specific performance metrics that would be required to answer many of your questions comprehensively.

The document primarily focuses on the device's intended use, its classification, and its substantial equivalence to a predicate device based on software verification and validation.

However, based on the information provided, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The document only states: "The results of the performance data demonstrate equivalence to the predicate device." It does not provide specific acceptance criteria or quantitative performance metrics.

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

This information is not available in the provided document.

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

This information is not available in the provided document.

4. Adjudication method for the test set:

This information is not available in the provided document.

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:

This information is not available in the provided document. The device described appears to be a tool for measuring intravascular pressure, not an AI for image interpretation that would typically involve human readers.

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

The document mentions "Software Verification" and "Software Validation" as performance testing. This suggests that the algorithm's performance was evaluated in a standalone manner, but no details about the methodology or results are provided. The "iFR Scout" is described as a "new software feature," implying it's an algorithmic component.

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

This information is not available in the provided document. Since the device measures intravascular pressure, the ground truth would likely be based on established physiological metrics or comparison to other gold-standard pressure measurement techniques, but this is not specified.

8. The sample size for the training set:

This information is not available in the provided document.

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

This information is not available in the provided document.

Summary of what is available from the document regarding the study:

• Type of Study: The document refers to "Performance testing completed for a determination of substantial equivalence included the following: Software Verification, Software Validation."
• Purpose: The testing was done to demonstrate "equivalence to the predicate device."
• Device Function: The "iFR Scout" feature allows assessment of lesions or vessels by placing a pressure sensor distally, recording/measuring, and pulling the sensor back through the vessel to map wave-free pressure gradient iFR values.
• Predicate Device: Volcano iFR® Modality (K133323)

To answer your questions comprehensively, a more detailed study report or clinical data summary would be required. The 510(k) summary is a high-level overview for regulatory clearance and does not typically include the granular details of performance studies.

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The iFR® Modality of the s5/s5i/CORE/CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

The Volcano iFR® Modality is new software that calculates blood pressures in the coronary and peripheral vasculature through isolation of the cardiac wave cycle where intracoronary resistance is naturally constant and minimized and where intracoronary flow is maximized. This results in the ability to measure pressure without the administration of a hyperemic agent.

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.

Here's a breakdown of the acceptance criteria and study details for the Volcano iFR® Modality, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or accuracy thresholds. Instead, it presents the "Study Results" as the performance metrics achieved by the device. The conclusion states that "The results of the performance data demonstrate equivalence to the predicate device."

However, we can infer that the reported performance metrics (sensitivity, specificity, PPV, NPV, and diagnostic accuracy) act as the de facto "acceptance criteria" that the device met to demonstrate equivalence.

Interpretation: The "acceptance criteria" are implied by the demonstration of a "statistically high correlation" with FFR and the favorable percentages of patients/lesions where hyperemic agents could be avoided.

Study Information

Here's the detailed breakdown of the ADVISE II study, which provided the clinical data for the iFR® Modality:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 690 lesions. 598 patients.
   • Data Provenance: Prospective, observational, non-randomized, double-blind, global, multi-center registry. This indicates data from various countries/sites. Specific countries are not detailed in the summary.

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

   • The document states that the iFR values were calculated at the "core lab using the HARVEST software (investigators were blinded to the iFR results)." The ground truth (FFR) was obtained using "standard guidelines for the FFR procedure."
   • Number of Experts: Not explicitly stated how many individuals or experts were involved in the "core lab" analysis or in performing the FFR procedures.
   • Qualifications of Experts: Not explicitly stated, but performing FFR and interpreting its results typically involves interventional cardiologists or highly trained catheterization lab personnel. The "core lab" would likely have experienced personnel for data processing and analysis.

3. Adjudication method for the test set:

   • Not explicitly described as a formal adjudication process between multiple readers. The ground truth (FFR) was established from direct physiological measurement. The "Hybrid approach" used FFR to categorize a subset of iFR values, which is a predefined algorithm rather than an inter-expert adjudication. The "counts provided in the cells of the below 2x3 matrix were provided by the study core laboratory," suggesting a single source for applying the FFR criteria.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with/without AI assistance was not explicitly mentioned or conducted as described. This study directly compared the iFR modality (software-calculated pressure measurement) against FFR (a standard physiological measurement) as a diagnostic tool. It wasn't about humans interpreting images with or without AI.

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

   • Yes, the performance metrics (sensitivity, specificity, etc.) presented are for the iFR Hybrid method in comparison to FFR. The iFR calculation itself is an "algorithm only" process where the software calculates the iFR from pressure wire data. While physicians perform the initial data acquisition, the iFR value itself is generated by the device's software without human interpretation or adjustment of the core iFR calculation. The "Hybrid approach" then uses these iFR values to selectively determine if FFR is needed, which is also an algorithmic decision-making process.

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

   • The ground truth was established using Fractional Flow Reserve (FFR) measurements, which is a universally accepted physiological measurement of coronary stenosis severity performed using a pressure wire and a hyperemic agent (adenosine). FFR values ≤ 0.80 were considered indicative of ischemia, and FFR values > 0.80 were considered not ischemic. This is a physiological reference standard, often considered a gold standard in cardiology.

7. The sample size for the training set:

   • The document describes the ADVISE II study as providing clinical data to support the iFR modification. It does not explicitly mention a separate "training set" for the iFR algorithm within the context of this 510(k) summary. The iFR modality is described as "new software that calculates blood pressures." It's possible the core iFR algorithm was developed and trained prior to this study, or it might be based on physiological principles rather than machine learning training on a dataset. The ADVISE II study appears to be a validation study for the overall performance of the iFR modality, not a study used for "training" the algorithm.

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

   • As no training set is explicitly described in this submission for the iFR algorithm itself, the method for establishing its ground truth is not provided. The ADVISE II study focused on validating the iFR Modality against FFR.

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