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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. general angiography, 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 the following indications for use:

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.

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

The new ARTIS icono (VE2) 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 (VE2) 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 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 (VE2), modular angiography systems are designed as sets of components that may be combined into two different configurations (Biplane or Floor) to provide specialized angiography systems. In general they are equipped with Carm, stand, flat panel detector, X-rav tube, collimator, high voltage generator, patient table, and image post processing.

The ARTIS icono (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, angiography and radiographic/fluoroscopic procedures.

The following components are configured to create a Floor or Biplane configuration:

• (1) Floor stand with 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

Images and operating elements are displayed on screens. Depending on the ARTIS icono (VE2) 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 (VE2) System is capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor and on the ceiling.

Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

The provided text describes performance testing for Siemens Medical Solutions USA, Inc.'s ARTIS icono (VE2) System, specifically focusing on product claims related to improved automatic exposure control and roadmap features.

Here's an organized breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "Labeling Claim" for each feature and the comparative performance against a "detector-driven exposure control" (for AEC claims) or an "old protocol" (for DSA Roadmap claims). The reported device performance aligns directly with these claims.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the 'sample size' in terms of patient data or a specific test set. The performance claims are based on phantom studies.

• Test Set Description: The testing was conducted using phantoms. Specifically, phantoms composed of PMMA (Polymethyl methacrylate) and aluminum plates were used to reproduce x-ray absorption and scattering at various patient equivalent thicknesses (e.g., 2.5-40 cm). These phantoms contained specific inserts like 0.01 mm thick platinum foil, 0.01 mm thick tantalum foil, 0.25 mm thick iron foil, a 4 mm thick cavity filled with iodine-based contrast material, and a 4 mm thick CO2-filled cavity. For the DSA claim (3f), a phantom with PMMA plates and a rotating tin foil insert simulating a vessel was used.
• Data Provenance: The studies are non-clinical performance tests conducted during product development by Siemens Healthcare GmbH. The country of origin of the data is implicitly Germany, where the Manufacturing Site (Siemens Healthcare GmbH, Forchheim, Germany) is located. The studies are prospective in the sense that they were conducted for the purpose of demonstrating the device's performance against specific claims during product development, prior to this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for these specific performance claims. The ground truth for the performance claims (dose savings, CNR maintenance, etc.) was established through physical measurements and calculations using defined phantom setups and comparative analyses (e.g., CNR-driven exposure control vs. detector-driven exposure control; new DSA protocol vs. old DSA protocol). There is no mention of human expert consensus for these quantitative physical performance metrics.

4. Adjudication Method for the Test Set

Not applicable. The reported performance metrics (dose savings, CNR) are objective, quantitative measurements derived from phantom experiments, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes phantom-based performance studies, not MRMC studies. There is no information provided about human readers, AI assistance, or effect sizes of how human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies are analogous to standalone performance evaluations, as they assess the device's (or its algorithms/features') performance in a controlled, objective setting using phantoms, without human intervention in the measurement of the core metrics (dose, CNR). The "Improved Automatic Exposure Control" and "Improved Roadmap (DSA)" features are algorithm-driven optimizations.

7. The Type of Ground Truth Used

The ground truth for the performance claims is based on objective physical measurements and calculations from specialized phantoms. These measurements quantify dose and contrast-to-noise ratio (CNR), which are inherent physical properties and imaging characteristics under controlled conditions.

8. The Sample Size for the Training Set

The document does not provide details on the training set size for any underlying algorithms, as the focus is on the performance testing of the device's features. This submission appears to be for an updated version (VE2) of an already cleared device, with product claims validated through non-clinical testing.

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated. As these are performance claims for device features (Automatic Exposure Control and improved Roadmap functionalities), the "training" (development) of such algorithms would typically involve engineering principles, physical modeling, iterative development, and internal testing against desired performance targets (e.g., maintaining CNR while reducing dose). The ground truth for these developmental or training stages is not detailed in this regulatory submission document.

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