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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.

The FFR v2.5 software is used to obtain pressure measurements and is installed on the Volcano s5/CORE Systems. These systems are a multi-modality platform that provides Intravascular Ultrasound (IVUS) Imaging, Fractional Flow Reserve (FFR) pressure measurements, and Instant Wave-Free Ratio (iFR) pressure measurements. Pressure measurements are obtained through the use of pressure guide wires. Real-time image visualization of patient anatomy during procedures.

FFR pressure measurements are obtained during fluoroscopic procedures after the administration of a hyperemic agent such as adenosine. iFR pressure measurements do not require the use of a hyperemic agent. The FFR Modality is calculated based on the entire cardiac wave cycle, whereas the iFR® Modality is calculated by 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 administration of a hyperemic agent with the iFR® Modality whereas the FFR Modality pressure reading is calculated after administration of a hyperemic agent.

Modifications to the software include the ability to take FFR and iFR measurements without relying on ECG and allowing for broadcast FFR and iFR measurement data to a third party system over a network.

The provided text describes the 510(k) summary for the FFR v2.5 device, which is a software modification to an existing device (iFR Scout, FFR v2.4). The core claim is substantial equivalence to the predicate device, not necessarily meeting specific acceptance criteria through a clinical study.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

There are no specific quantitative acceptance criteria or reported device performance metrics in the provided document. The submission relies on demonstrating substantial equivalence to a predicate device. The performance is implied to be equivalent to the predicate (iFR Scout, FFR v2.4).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The FFR v2.5 software did not require clinical data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."

Therefore, there was no test set of patient data used for a clinical study as part of this 510(k) submission. The non-clinical performance testing involved software verification and validation, but details on sample sizes for these tests (e.g., number of test cases, simulated scenarios) are not provided, nor is their provenance in terms of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical data or test set involving patient data was used, there were no experts involved in establishing ground truth for a clinical test set. The evaluation was primarily based on non-clinical software testing and comparison to the predicate device.

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

None, as no clinical test set was utilized.

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 was done. The submission did not involve clinical data or evaluation of human readers with/without AI assistance. The device is a software modification to a measurement system, not a diagnostic AI tool for human readers.

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

The document mentions "Software verification testing has been performed to cover system level requirements as well as risk control measures. Results demonstrated that all executed tests were passed." and "Non-clinical validation testing has been performed to cover the intended use, commercial claims, service, user needs, effectiveness of safety measures and instructions for use."

While these describe standalone performance testing of the algorithm/software, specific details about the methodology, metrics, or if it constitutes a "standalone study" in the context of clinical performance are not provided. The objective was to ensure the modified software functions correctly according to specifications, not to establish clinical performance metrics in isolation.

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

For the software verification and validation testing, the ground truth would have been pre-defined expected outputs and behaviors based on system requirements and predefined calculations/algorithms for FFR and iFR measurements. This is not equivalent to clinical ground truth established by medical experts or pathology.

8. The sample size for the training set

Not applicable. This submission is for a software modification (FFR v2.5) that is substantially equivalent to a predicate device (FFR v2.4). There is no indication that this particular submission involved a machine learning model requiring a training set. The descriptions point to traditional software development and testing rather than AI model development.

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

Not applicable, as no training set (for a machine learning model) is mentioned in this submission.

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The Pioneer Plus catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus catheter also provides an intraluminal cross-sectional ultrasound image of interest to facilitate placement of guidewires beyond stenotic lesions (e.g., sub-total, total occlusions) prior to additional intervention (i.e. PTA, stent, etc.). The Pioneer Plus catheter is not indicated for use in the coronary or cerebral vasculature.

The Pioneer Plus catheter is a dual lumen catheter that is inserted through a commercially available 6F introducer sheath and placed percutaneously into a peripheral vessel. The Pioneer Plus catheter tracks to its intended site in the vasculature over a standard, commercially available 0.014" (0.36 mm) tracking guidewire. The Pioneer Plus catheter utilizes an extendable, hollow Nitinol needle - minimum internal needle diameter: 0.016" (0.43 mm): it is compatible with floppy 0.014" (0.36 mm) over the wire (OTW) guidewires to facilitate the redirection and placement of the guidewire into peripheral vessels. The needle orientation placement is achieved through the use of an intravascular ultrasound (IVUS) transducer mounted at the distal end of the Pioneer Plus catheter. The Pioneer Plus catheter operator navigates the peripheral vasculature under fluoroscopic guidance and uses IVUS imaging to direct the needle to achieve optimal placement. The operator uses the Needle Deployment Ring incorporated into the handle of the Pioneer Plus catheter to extend the needle from the catheter. The needle can be extended up to 7mm in length, or to a pre-determined distance using the Stop Ring. A 0.014" (0.36 mm) OTW guidewire (needle guidewire) can then be advanced through the needle and used to facilitate the placement of subsequent catheters once the Pioneer Plus device is withdrawn.

The provided text describes an FDA 510(k) summary for a medical device called the "Pioneer Plus Catheter." The acceptance criteria and the study proving the device meets these criteria are outlined in the "PERFORMANCE DATA" section.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that "All testing met the acceptance criterial with 95/95 confidence/reliability."

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

• Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of catheters tested for Bend Radius). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the modified device."
• Data Provenance: Not specified. The tests are described as "Bench testing," indicating they were performed in a lab setting, likely by the manufacturer (Philips Volcano). There is no information regarding country of origin of data, and it is inherently a prospective study as it's testing a modified device's performance.

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

This information is not provided in the document. The testing appears to be focused on engineering performance criteria rather than human interpretation or clinical outcomes that would require expert ground truth.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The tests are objective engineering measurements (e.g., OD measurement, tensile strength) rather than subjective assessments requiring adjudication.

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 provided and is not applicable to the type of device and testing described. The Pioneer Plus Catheter is a physical medical device (catheter with ultrasound imaging), not an AI-driven diagnostic or assistive tool for human readers.

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

This information is not provided and is not applicable. The device is not an algorithm, but a physical catheter. While it incorporates an intravascular ultrasound (IVUS) transducer, the performance evaluation described focuses on the physical integrity and characteristics of the catheter itself, not the standalone performance of an ultrasound imaging algorithm.

7. The type of ground truth used:

The ground truth for the performance tests appears to be known standards or product specifications. The document states, "Bench testing was conducted against known standards or product specification."

8. The sample size for the training set:

This information is not provided. The document describes testing of a physical medical device against engineering specifications. There is no mention of a "training set" as would be relevant for machine learning or AI algorithms.

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

This information is not provided as there is no mention of a "training set."

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