(28 days)
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.
§ 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.