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The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/ hemodynamic monitoring, medical data processing and analytical assessment.

The software may be used to display analyze surface Electrocardiogram (ECG), Respiration. Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output.

The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices.

Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.

The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet.

The software is indicated for use in the following areas; (interventional) cardiology, electrophysiology,

The Philips Hemodynamic Application is indicated for use for all human patients of all ages.

Philips Hemodynamic Application is a new software medical device that enables invasive investigation of cardiac and vascular disease. It will be offered as an optional accessory to the Xper Flex Cardio Physiomonitoring System, (K101571). Currently, the functionality offered by the Philips Hemodynamic Application is provided by "Hemodynamic Control Software" of the currently marketed and predicate Xper Flex Cardio Physiomonitoring System.

The software connects to the patient monitor (i.e. the Xper Flex Cardio Physiomonitoring System) and during the intervention continuously acquires realtime physiological data and alarms. In addition, Philips Hemodynamic Application provides the following functionality:

• Visualize and analyze: surface ECG, Respiration rate (RR), Invasive . Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (etCO2), Noninvasive monitoring and recording of Non-Invasive Blood Pressure (NIBP), Body surface temperature (Tskin);
• Provide Hemodynamic calculations: Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), thermal cardiac output parameters, valve area and valve gradient.

Furthermore, Philips Hemodynamic Application also interfaces with Xper Information Management (XperIM) System (K101571) which it can transfer data to for the purpose of data collection/display, processing and patient reporting.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with numerical performance metrics. Instead, it describes non-clinical performance and validation testing that supports the device's substantial equivalence to a predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It states: "All these tests were used to support substantial equivalence of the subject device and demonstrate that Philips Hemodynamic Application: • complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents, and • meets the acceptance criteria and is adequate for its intended use."

It also mentions "Algorithm verification was performed using calibrated simulator tools that confirmed the algorithm was correctly implemented in the product. Results demonstrated that all executed verification tests were passed." and "In-house simulated use design validation was performed with experienced Clinical Marketing specialists that fulfill the intended user profile... As part of the validation, the implemented algorithms were evaluated as part of the workflow. Results demonstrated that all executed validation protocols were passed."

This indicates that acceptance criteria were met, but the specific numerical targets and measured performance are not detailed in this summary. The acceptance criteria seem to be binary (pass/fail) based on compliance with standards and successful algorithm implementation and workflow validation.

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

• Test Set Sample Size: Not explicitly stated. The verification and validation activities are described qualitatively.
• Data Provenance: Not specified. The verification was done using "calibrated simulator tools," and validation involved "simulated use environment" and "in-house simulated use design validation." This suggests internal testing without specific patient data provenance mentioned.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: For usability validation, it involved "cardiologists and monitoring nurse/technicians." For in-house simulated use design validation, it involved "experienced Clinical Marketing specialists that fulfill the intended user profile." Specific years of experience or board certifications are not provided.

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

Not mentioned in the 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:

No MRMC comparative effectiveness study involving human readers or AI assistance is mentioned. The device, "Philips Hemodynamic Application R1.0," is described as a software medical device for physiological/hemodynamic monitoring, data processing, and analytical assessment, not specifically an AI-based interpretation tool that assists human readers in diagnostic tasks in the way typically associated with MRMC studies.

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

Algorithm verification was performed using "calibrated simulator tools that confirmed the algorithm was correctly implemented in the product." This could be considered a form of standalone performance assessment for the algorithms' mathematical correctness. However, it's not a standalone clinical performance study. The device is intended for use by "professional healthcare providers," implying human-in-the-loop operation.

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

The document implies that the ground truth for algorithm verification was derived from the expected outputs of the "calibrated simulator tools." For validation, the "implemented algorithms were evaluated as part of the workflow" by experienced specialists, suggesting a functional ground truth based on expected performance in a simulated clinical workflow. No mention of pathology or outcomes data is made.

8. The sample size for the training set:

The document does not describe the use of a training set for machine learning. The device is presented as applying "comparable technology as implemented in the Hemodynamic Control Software module" and implementing algorithms for hemodynamic calculations, including an iFR algorithm, without indicating machine learning or AI models requiring discrete training data.

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

Not applicable, as no training set for machine learning is mentioned.

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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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