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The IVUS modality of the iLab™ Polaris Multi-Modality Guidance System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.

The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.

Indications for Auto Pullback Use (IVUS Only)

Automatic Pullback is indicated when the following occurs:

· The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.

· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.

· Two-dimensional, longitudinal reconstruction of the anatomy is desired.

iLab™ Polaris Multi-Modality Guidance System consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the DFR™ (Diastolic hyperemia-Free Ratio) feature of the iLab™ Polaris Multi-Modality Guidance System:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the DFR™ feature is its equivalence to the iFR® (Instantaneous Wave-Free Ratio) modality, with both being compared against Fractional Flow Reserve (FFR) as a reference standard. The study aimed to demonstrate that DFR™ has comparable diagnostic performance to iFR® when assessing coronary lesion severity without hyperemia.

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

• Test Set Description: The test set for DFR™ and Smart Minimum validation consisted of pre-recorded patient level data.
• Data Provenance: The data was acquired from two clinical trials:
  • VERIFY2
  • CONTRAST
  • Geographic Origin (implied): Not explicitly stated, but clinical trials like VERIFY2 and CONTRAST are typically multi-center studies that can involve patients from various countries. The document does not specify the countries of origin.
  • Retrospective/Prospective: The data appears to be retrospective as it is described as "pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials" for the purpose of validating the new software features.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth for the test set (i.e., FFR values). However, given that FFR is considered the "reference standard" and typically relies on highly trained cardiologists/interventionalists, it can be inferred that these values were established by qualified medical professionals during the original clinical trials (VERIFY2 and CONTRAST).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The FFR values used as the reference standard were presumably established as part of the original clinical trials' protocols.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported here. The study focuses on the algorithmic performance of DFR™ in comparison to iFR® and FFR, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance study was conducted. The document describes:

• "Smart Minimum and DFR were validated with non-clinical test methods"
• "iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system."
• "BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires... and St Jude pressure wires..."
• The primary comparison is between DFR™ and iFR® (both algorithms) against FFR (the reference standard).

The data presented (97.6% Accuracy, 99.2% Specificity, 95.8% Sensitivity) reflects the algorithmic performance of DFR™ in classifying lesions.

7. Type of Ground Truth Used

The primary ground truth used for evaluating DFR™ and iFR® was Fractional Flow Reserve (FFR).
Additionally, the "original iFR values" from the VERIFY2 dataset served as a reference for validating the bench iFR setup.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of a training set for the DFR™ algorithm. The validation was performed using pre-recorded patient data from existing clinical trials (VERIFY2 and CONTRAST). It's common for such algorithms to be developed and potentially trained on various datasets prior to this validation, but those details are not included in this submission summary.

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

Since information on a specific training set or its sample size is not provided, how its ground truth was established is also not described in the document.

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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 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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