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ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general anglography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.

The ARTIS family include also the software option DynaCT with following indications for use: DynaCT is an X-ray maging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS icono (VE23) system is a medical device that allows visualization of vessels within the human body. It is of the utmost importance to find the right projections so physician can navigate catheters and other devices safely. The ARTIS icono (VE23) system consist of a patient table and a multi-axis motorized c-arm that can be positioned around the patient and angulated in a double-oblique fashion isocentering the region of interest between the x-ray tube and the flat panel detector. The x-ray generator is placed separately. The displays for visualizing the x-ray images are mounted at the ceiling with a movable display suspension system. System operation is executed via control modules table side so that the physician can move and position the table and c-arm adequately for best imaging while manipulate the catheters or other devices during x-ray. X-ray release is table side via a footswitch.

The ARTIS icono (VE23) ceiling mounted system covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, and radiographic/fluoroscopic procedures.

The following components are configured to create the Ceiling configuration:

• (1) Ceiling Mounted C-arm, X-ray tube assembly and FD
• (2) Patient table
• (3) Display ceiling suspension with displays
• (4) Footswitch for releasing radiation
• (5) Control console for controlling the stand, patient table and imaging system
• (6) Ceiling Rails (two configurations)

Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE23) system configuration, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information content in various layouts are used.

Post processing can be done in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS icono (VE23) ceiling System is capable of 2D and 3D imaging.

Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE23) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the Siemens ARTIS icono (VE23) System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical performance or a specific AI algorithm.

Therefore, the document does NOT contain the information required to answer questions 1 through 9 regarding acceptance criteria and performance study details of an AI device.

The document primarily describes a traditional medical imaging device (an angiography system) and its software updates. It mentions that "ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis" and that "DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format." These are general imaging capabilities and not an AI algorithm with specific clinical acceptance criteria.

The "modifications" listed (Updated system Software from VE20 to VE23, New Generator, Peristepping/Perivision, Ceiling configuration, Product Claims List, Update 510(k) Information) are primarily engineering and hardware/software updates to the existing system, not the introduction of a new AI-powered diagnostic or assistive tool.

The "Nonclinical Performance Testing" section focuses on compliance with electrical safety, performance, electromagnetic compatibility, and software development standards (e.g., IEC 60601 series, IEC 62304, ISO 14971), and usability validation, not on clinical performance metrics for a specific algorithm.

In summary, this document is for a conventional angiographic imaging system and does not contain the specific information about acceptance criteria and a study that proves an AI device meets those criteria.

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