(121 days)
Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy.
Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan.
The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software is therefore not recommended for use in patients under the age of 18.
IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the pre-operative position
It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device.
Cydar EV is a Software-as-a-Service product and consists only of the software running on Cydar's cloud servers. Cydar EV enables expert clinical users to build an operative plan, called a Pre-operative Map, which consists of 3D blood vessel anatomy from the patient's CT scan. measurements, and other annotations deemed relevant by the clinical user. During surgery, Cydar EV's fusion imaging superimposes the Pre-operative Map on a duplicated display of the X-ray fluoroscopy. The clinical users can interact and non-rigidly transform a copy of the Map, called the Adjusted Map, when they see that the real-time anatomy has deformed. After surgery, clinical users can review data about the case via the web interface.
No specific accessories are required for the use of Cydar EV. The software is provided as a service and accessed via standard web browser. For intra-operative fusion imaging use, the browser is run on a client PC device called the Cydar Appliance. The Cydar Appliance is an off-the-shelf video frame grabber and is not in itself a medical device nor considered in the scope of this 510(k) submission. The Windows image on the PC (ie Cydar Appliance) is controlled by Cydar and not configurable by the end-user. The Cydar Appliance may display its output on one or more external monitors via standard video connections e.g DVI or HDMI (in addition to any built-in display). A particular installation of the PC (ie Cydar Appliance) may provide a touchscreen and/ or peripheral devices such as mice, trackpads, keyboards, and handheld remote control to operate the user interface of the Cydar EV service. The software implementing the upload of CT scans in DICOM format ('Cydar Gateway ') is a medical image communications device and is therefore also not considered in the scope of this 510(k) submission.
Unfortunately, the provided text does not contain the specific details about acceptance criteria, reported device performance, or the study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) for the Cydar EV Series B and Cydar EV Maps device.
The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of performance studies. It mentions that "Software verification and validation were conducted to establish the performance, functionality and reliability characteristics of this device, with particular focus on the modified features. The device has passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not elaborate on what those criteria were, what the results were, or the specifics of the studies performed.
Here's a breakdown of what is and isn't present:
What is available in the text:
- Device Name: Cydar EV Series B, Cydar EV Maps
- Intended Use: Assisting fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy.
- Specific features mentioned: Import/visualize CT data, segment/annotate vascular anatomy, place/edit virtual guidewires and measure lengths, make measurements of anatomical structures on planar sections of CT data, produce operative plan, overlay planning information onto live fluoroscopic images, non-rigidly transform visualization of anatomy when intra-operative vessel deformation is observed, post-operatively review data.
- Claim of verification and validation: "Software verification and validation were conducted to establish the performance, functionality and reliability characteristics of this device, with particular focus on the modified features. The device has passed all of the tests based on pre-determined Pass/Fail criteria."
- Nature of the device: Software-as-a-Service product, software only medical device.
- Target users: Experienced medical practitioners specializing in endovascular surgery (vascular surgeons, interventional radiologists), radiographers, specialist nurses.
- Ground truth mentions (general): "The information and measurements displayed, exported or printed are validated and interpreted by Physicians." and "Measurement accuracy verification testing and summative user study is performed as part of the design and development process."
What is NOT available in the text regarding acceptance criteria and performance study details:
- A table of acceptance criteria and the reported device performance: The document states that "The device has passed all of the tests beased on pre-determined Pass/Fail criteria" but does not list these criteria or the specific performance metrics achieved.
- Sample sized used for the test set and the data provenance: No information on the number of cases or patients used for testing, nor where the data originated (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: While it mentions "trained clinical specialists" and "Physicians" interpreting information, it doesn't specify how many were involved in establishing ground truth for testing, or their exact qualifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned. The document describes the device as intended to "assist" procedures but doesn't quantify this assistance with comparative effectiveness metrics.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document emphasizes user interpretation ("dependant on the interpretation of trained clinical specialists") and "measurement accuracy verification testing," but doesn't explicitly state if standalone algorithm performance was assessed separate from human-in-the-loop. Given it's an "assistive" device, human interaction is inherent to its intended use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): While "Physicians" validate and interpret, the specific method for establishing "ground truth" (e.g., whether it was expert consensus alone, or validated against pathology or surgical outcomes) is not detailed.
- The sample size for the training set: No information is provided regarding the training data for any underlying algorithms.
- How the ground truth for the training set was established: No information is provided regarding the training data.
To obtain this level of detail, one would typically need to refer to detailed study reports, peer-reviewed publications, or the full 510(k) submission, portions of which are often confidential. This summary document provides a high-level overview for regulatory clearance.
§ 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.