(174 days)
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.
Cydar EV is intended to assist fluoroscopy-guided endovascular procedures in the lower thorax, abdomen and pelvis. Suitable procedures include (but are not limited to) endovascular aortic aneurysm repair (AAA and mid-distal TAA), angioplasty, stenting and embolization in the common iliac, proximal external iliac and proximal internal iliac arteries and corresponding veins.
Cydar EV is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.
Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV provides augmented reality enhanced X-ray fluoroscopy images for use during X-ray guided surgery.
Cydar EV is a software only medical device. It defines minimum requirements to the hardware it runs on. Access to Cydar EV will be effected by a secure connection over either private networks or the public Internet.
The cloud communication, storage and processing solution is operated and maintained by specially trained Cydar Ltd staff and is based on the Ubuntu Linux operating system (versions 12.4 and 14.4). The client machines are based on Microsoft Windows 8.1, running the Google Chrome web-browser (version 47) and equipped with a video framegrabber (Foresight AccuStream Express HD+). The client machine captures a live fluoroscopy video feed from the X-rays machine's external (secondary) video port using HDMI, DVI, S-video, or analogue format. Any platform, which complies with the specified minimum hardware and software requirements and with successful system self-test and validation activities can be supported.
The Cydar EV will be marketed as a software only solution for the end-user (with recommended hardware requirements). Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by specially trained service technicians.
The provided text describes the non-clinical and clinical performance data for the Cydar EV device, but the acceptance criteria and related study details are not explicitly organized into a table format within the document. However, I can extract the relevant information and present it in the requested structure.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with IEC 62304 (Medical device software – Software life cycle processes) | Applied and demonstrated compliance |
| Compliance with IEC 62366-1 (Medical devices – Application of usability engineering to medical devices) | Applied and demonstrated compliance |
| Compliance with ISO 14971 (Medical devices – Application of risk management to medical devices) | Applied and demonstrated compliance |
| Compliance with NEMA PS 3.1-3.20 DICOM Set (2011) | Applied and demonstrated compliance |
| Compliance with FDA Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) | Demonstrated compliance |
| Software Verification Tests: | |
| Registration accuracy from vertebral anatomy images | Accuracy demonstrated (calculated from images) |
| Overlay alignment accuracy in web browser display | Accuracy demonstrated |
| Information security | Demonstrated security |
| Responsiveness of overlays to changes in fluoroscopy imagery | Demonstrated responsiveness |
| Software Validation Tests: | |
| Fulfilled intended use and commercial claims | Demonstrated by usability testing |
| Usability testing with representative clinical users | Demonstrated ease of use, visibility, and legibility of displays and overlays |
| Usability testing with system operators and IT staff | Demonstrated usability |
| Testing of the vessel segmentation tool | Demonstrated functionality |
| System availability and up-time | Demonstrated availability and up-time |
| Clinical Performance: | |
| Accuracy of image guidance | Achieved accurate image guidance |
| Robustness of image guidance | Achieved robust image guidance |
| Usability of image guidance | Achieved usable image guidance |
| Procedure time | Addressed as a primary endpoint, but specific values are not provided in this summary. |
| Radiation exposure | Addressed as a primary endpoint, but specific values are not provided in this summary. |
| Iodinated contrast volume | Addressed as a primary endpoint, but specific values are not provided in this summary. |
2. Sample size used for the test set and the data provenance
- Non-clinical performance (Software verification & validation): The document does not specify a distinct "test set" sample size in terms of number of images or cases for the non-clinical tests. It refers to "images of the vertebral anatomy" for registration accuracy, but no count is given. The testing was performed by Cydar Ltd.
- Clinical Performance: "The design was a multi-centre observational study." The document does not specify the exact number of participants ("subjects") for the clinical study. Data provenance is not explicitly stated as country of origin, but the sponsor, Cydar Ltd, is located in the UK. The study was "observational." It is not directly stated whether it was retrospective or prospective, but the phrasing "were scheduled to undergo an X-ray guided intervention" and "had had a pre-operative CT scan" suggests it was prospective, recruiting patients for future procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for either the non-clinical or clinical test sets.
4. Adjudication method for the test set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets.
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
A multi-reader multi-case (MRMC) comparative effectiveness study explicitly comparing human readers with AI vs. without AI assistance is not described in this document. The clinical study was an "observational study examining safety, performance, usability, and clinical effect" of the Cydar EV device itself, rather than a comparative effectiveness study with and without the AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, several aspects of the device's performance were assessed in a standalone manner as part of the "Software verification testing." This included:
- Registration accuracy calculated from images of the vertebral anatomy.
- Overlay alignment accuracy in the web browser display.
- Information security.
- Responsiveness of overlays to changes in the fluoroscopy imagery.
- Testing of the vessel segmentation tool (part of software validation).
These tests evaluate the algorithm's performance independent of real-time human interaction for their specific metrics.
7. The type of ground truth used
- Non-clinical performance: For registration accuracy, the ground truth was derived from "images of the vertebral anatomy" used to calculate accuracy. The exact method of establishing this ground truth (e.g., manual expert annotation, phantom measurements) is not explicitly detailed but implied to be based on established measurements. For other software tests, the ground truth was inherently defined by the expected software behavior and outputs.
- Clinical Performance: The "clinical investigation was conducted to evaluate safety and efficacy" and measured "accuracy, robustness, usability, procedure time, radiation exposure, and iodinated contrast volume." The ground truth for judging "accuracy" of image guidance would likely be based on the actual positioning of guidewires/catheters relative to the true anatomy observed during the procedure, potentially confirmed by expert observation or other imaging modalities, though this is not explicitly detailed. "Usability" and "robustness" would be based on user feedback and system performance during clinical use.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for the training set of the Cydar EV software. It focuses on the evaluation (test) of the final product.
9. How the ground truth for the training set was established
Since no information is provided on the training set, there is no detail on how its ground truth was established.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.