(129 days)
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).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative acceptance criteria. The document focuses on demonstrating substantial equivalence to the predicate device in terms of: | The FFR v2.5 software is considered substantially equivalent to the iFR Scout (FFR v2.4) based on: |
| - Indications for Use | - FFR v2.5 Modality 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 with currently marketed Volcano pressure wires. This is equivalent to the predicate. |
| - Technological characteristics | - Maintains the same fundamental scientific technology. Modifications (ECG-less Cardiac Cycle Detection, FM Broadcast) do not raise new safety or effectiveness questions. |
| - Non-clinical performance testing | - Demonstrated compliance with IEC 62304 and FDA guidance documents. Software verification testing covered system-level requirements and risk control measures, with all executed tests passed. Non-clinical validation testing covered intended use, commercial claims, service, user needs, effectiveness of safety measures, and instructions for use. |
| - Safety and effectiveness | - Considered equally safe and effective as the predicate device. |
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.