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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:

1. 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.
2. 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).
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not mentioned. The document describes the device as intended to "assist" procedures but doesn't quantify this assistance with comparative effectiveness metrics.
6. 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.
7. 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.
8. The sample size for the training set: No information is provided regarding the training data for any underlying algorithms.
9. 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.

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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

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.

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