(29 days)
The Volcano s5i®/CORE™ and CORE™ Mobile Precision Guided Therapy 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.
The VH® IVUS System 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 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.
The iFR® Modality of the s5/s5//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.
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 PIMr withdraws the imaging core within the protective sheath for a maximum of 15 cm.
The Volcano s5i®/CORE™ and CORE™ Mobile Precision Guided Therapy System provides 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. Intravascular ultrasound (IVUS) utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves.
The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image.
These grayscale images can then be enhanced using VH IVUS. VH analysis provides automatic border detection for the vessel and lumen borders, as well as plaque composition. Plaque is automatically classified into four categories in order to simplify interpretation of the IVUS image
Alternatively, the ChromaFlo feature can be used to identify the blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity onto the grayscale ultrasound image.
In the FFR (or pressure) mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established ECG/EKG catheterization laboratory equipment. The system will measure pressure from the transducer on the guide wire both proximal and distal to a lesion and will calculate the fractional flow reserve (FFR).
The iFR® Modality is similar to the FFR Modality in that both modalities are capable of taking pressure measurements and both modalities have the identical indications for use and use the identical pressure wires. The primary difference is a new software algorithm that evaluates a portion of the cardiac wave cycle. 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 is calculated after administration of a hyperemic agent.
iFR® Pullback and Live iFR are new features added to the iFR® Modality that will allow the assessment of a lesion (spot measurement) or vessel (pullback measurement) in a resting condition without the requirement of a hyperemic agent. The iFR® Pullback feature will allow the user to assess a length of vessel by placing the pressure sensor distally, beginning recording/measuring, and pulling 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 rotational mode is available on the system with the Revolution catheter connected to the system via the PIMr (SpinVision). Cross-sectional images from inside the vessel are displayed on the monitor allowing the user to make measurements.
The CORE™ Control Pad is a touch screen accessory that is a secondary controller in the Volcano s5i®/CORE™ and CORE™ Mobile Precision Guided Therapy System (integrated and mobile systems). Images, data, and case navigation controls are relayed to and from the CORE™ Control Pad display via the system central processing unit (CPU). These images, data and controls are presented in a graphical user interface (GUI) displayed on the touch screen of the CORE™ Control Pad. The user may use the GUI to navigate IVUS and FFR cases and to make measurements on intravascular ultrasound images that are presented on the primary system display.
The provided document, a 510(k) premarket notification, describes a medical device update to the Volcano s5/s5i/CORE and CORE Mobile Precision Guided Therapy Systems. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for regulatory approval, rather than presenting a detailed study of an AI/algorithm-driven device meeting specific performance acceptance criteria.
The information provided does not include the detailed breakdown of acceptance criteria and a study proving the device meets these criteria as if it were a novel AI or algorithm-driven diagnostic system. Instead, it discusses software updates (operating system and control pad functionality) and asserts substantial equivalence based on software verification and simulated use/usability validation.
Therefore, I cannot extract the granular information requested about acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies are not detailed in this 510(k) submission.
The closest I can get to the requested information, based only on the provided text, is to state that the performance data included:
- Software Verification
- Simulated Use / Usability Validation
And that the results of this performance data demonstrate equivalence to the predicate devices. There are no specific quantitative acceptance criteria or detailed study results presented for the device's diagnostic performance in the way one would expect for a new AI/ML-based diagnostic product (e.g., sensitivity, specificity, AUC).
For the sake of completeness and to address your request directly, I will explicitly state where the requested information is not present in the provided document:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "The results of the performance data demonstrate equivalence to the predicate devices" but does not quantify performance against specific criteria.
- Sample sizes used for the test set and the data provenance: Not provided. The testing mentioned is "Software Verification" and "Simulated Use / Usability Validation," without details on test set sizes or data origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No 'ground truth' establishment specific to diagnostic accuracy is detailed for these software updates. The "Simulated Use / Usability Validation" would likely involve users, but their 'expert' qualifications for establishing ground truth are not specified relevant to diagnostic performance.
- Adjudication method for the test set: Not applicable/Not provided. No adjudication method for diagnostic performance is described.
- 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 study described. The updates relate to operating system and control pad functionality, not a new AI-assisted diagnostic feature requiring such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is a 'Precision Guided Therapy System' with various imaging and pressure measurement modalities, not a standalone diagnostic algorithm. The updates are to underlying software and control.
- The type of ground truth used: Not applicable/Not provided. For the software updates, 'ground truth' would relate to correct software function and usability, not medical diagnoses.
- The sample size for the training set: Not applicable/Not provided. This is not a description of an AI/ML model's training process.
- How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document is a regulatory submission for device modifications that assert substantial equivalence, not a detailed clinical study demonstrating performance against specific diagnostic acceptance criteria for a novel AI/algorithm.
§ 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.