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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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The FACTS is intended to produce routine cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles of the entire human body. In addition, this device's fluoroscopic mode is intended to be used in CT interventional procedures and allows some minimally invasive surgical procedures to be implemented with the CT system. Procedures possible with this equipment include tumor biopsies, abscess drainages, bone intervention, visceral, neck trauma evaluation and catheter placement for organ assessment.

The FACTS X-Ray System, is a device intended to produce cross-sectional images of the human body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. The solid state x-ray imager is a device intended to be used to visualize anatomical structures by using a flat panel to convert x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

The provided text is a 510(k) summary for the Picker FACTS (Fluoroscopic Assisted Computed Tomography System) and does not contain information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.

Therefore, I cannot extract the requested information from the given text. The document primarily describes:

• Device Name: FACTS (Fluoroscopic Assisted Computed Tomography System)
• Classification Name: Computed Tomography X-Ray System and Solid State X-Ray Imaging Device
• Intended Use: To produce cross-sectional images of the human body by computer reconstruction of x-ray transmission data. Also, its fluoroscopic mode is intended for CT interventional procedures, including tumor biopsies, abscess drainages, bone intervention, visceral/neck trauma evaluation, and catheter placement for organ assessment.
• Predicate Devices: PQ2000+ CT System (K955268), C-Arm with DynaRad Diagnostic Source Assembly (K981267), and SSXI equivalent to the image intensifier of the Orbitor (K800639).
• Technological Characteristics: Claims substantial equivalence in features, specifications, materials, and mode of operation to predicate devices, stating no new questions of safety or effectiveness are raised.
• Regulatory Status: Granted marketing permission in K982010.

To answer your questions, I would need a different type of document, such as a clinical study report, a detailed design verification and validation report, or performance testing protocols and results.

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The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce a compatible video signal.

The Sony DKR-700 Digital Still Recorder is a general purpose electronic device for digitally recording both color and black and white still images from a variety of analog sources in either a noncompressed or compressed mode to a Sony Magneto Optical (MO) MiniDisc. Recorded images may then be played back from the MO disc and viewed on a standard (analog) video monitor, or may be transmitted via a SCSI interface for importing into a PC/Windows application environment. With the DKR-700, information such as date, image number and image name can be attached to each image. Specific images can then be searched for and retrieved at the user's request.

The major components of the Sony DKR-700 Digital Still Recorder are the recorder, the recording media and the DKR-700 plug-in software. The RM-C700 Remote Control Unit and foot switches are optional accessories for external control of the device.

The provided text describes a medical device, the Sony DKR-700 Digital Still Recorder, and its intended use, but it does not contain information about acceptance criteria, a study proving device performance, or any of the detailed metrics requested in your prompt.

The document is a 510(k) summary, which is a premarket notification submitted to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on technological characteristics and equivalence to predicate devices rather than detailed performance studies with acceptance criteria, ground truth, or expert review panels.

Therefore, I cannot populate the table or answer the specific questions about performance studies, sample sizes, experts, or ground truth with the information provided. The document outlines:

• Device Name: Sony DKR-700 Digital Still Recorder
• Intended Use: Recording video images from medical imaging systems for administration, patient record archival, and education. It's an accessory to various medical imaging devices.
• Predicate Devices: Sony DVR-10 Digital Videocassette Recorder and Sony Laser VideoDisc Recording (LVR) System.
• Technological Characteristics: Records digital still images from analog sources to a Sony Magneto Optical (MO) MiniDisc, with playback and SCSI interface for PC integration. The primary difference from predicates is the recording media.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a performance testing protocol, which are not present in this 510(k) summary.

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