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ARTIS is a family of dedicated angiography systems developed for single-plane 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 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.

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

The ARTIS systems include also the software option DynaCT with 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 for diagnosis, surgical planning, interventional procedures, and treatment follow-up.

The ARTIS icono (VE30A) 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 physicians can navigate catheters and other devices safely. The ARTIS icono (VE30A) consists 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 iso-centering 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 manipulating catheters or other devices during the x-ray. X-ray release is tableside via a footswitch.

The ARTIS icono (VE30A), 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 a Carm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing.

The ARTIS icono (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical multipurpose rotational angiography, angiography, angiography. 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 (VE30A) 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 contained 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 (VE30A) is capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor and the ceiling. Other systems and software syngo Application Software, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination and control rooms.

The provided text describes a 510(k) premarket notification for the ARTIS icono (VE30A) device, a medical imaging system. The submission aims to establish substantial equivalence to a predicate device (ARTIS icono (VE21)). However, the document primarily focuses on explaining modifications to the software and hardware, and the general testing conducted to support safety and effectiveness.

Crucially, the document does NOT contain specific acceptance criteria tables or detailed study results that prove the device meets those criteria in the way typically expected for a clinical performance study of AI/algorithm performance (e.g., Sensitivity, Specificity, AUC values).

The "Nonclinical Performance Testing" section mentions general types of testing performed (e.g., "Software functional, verification, and System validation testing with passing results," "CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing were conducted for Structure Scout new elements for the Organ program. All testing results passed."). This indicates that the device's technical specifications and intended functionality were verified, but it doesn't provide the type of performance metrics usually associated with proving diagnostic accuracy or clinical effectiveness.

Given the information provided, I cannot fulfill all parts of your request as the specific data on acceptance criteria and a detailed study proving the device meets those criteria (especially regarding AI/algorithm performance or human-in-the-loop studies) are absent. This document is a 510(k) summary, which often focuses on demonstrating substantial equivalence through technological comparison and non-clinical engineering/software validation, rather than extensive clinical efficacy trials.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that "All test results met all acceptance criteria" and "The testing results support that all the software specifications have met the acceptance criteria." However, it does not enumerate these criteria or provide quantitative performance results (e.g., sensitivity, specificity, accuracy, or metrics specific to imaging quality beyond qualitative "passing results"). The focus is on demonstrating that the modified components function as intended and do not introduce new risks, aligning with the "substantial equivalence" claim.

2. Sample size used for the test set and the data provenance

• Cannot be provided for the type of performance testing you are asking for. The document mentions "non-clinical tests" and "software functional, verification, and System validation testing." This testing typically involves engineering samples, simulated data, or phantoms, rather than a clinical patient test set with a specific sample size and geographic provenance for evaluating diagnostic performance. The document does not describe a clinical "test set" in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Cannot be provided. Since no specific clinical test set for diagnostic performance evaluation is detailed, there's no mention of experts establishing ground truth for such a set. The document focuses on technical verification and validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Cannot be provided. No clinical test set requiring adjudication is described.

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

• No. There is no mention of an MRMC study or AI assistance improving human readers. The device described is an X-ray imaging system, and the modifications mentioned are related to software features, usability, and hardware updates (e.g., updated memory, new PC, new elements for "Structure Scout" organ program, usability features). While a "software option DynaCT" is mentioned, the evaluation here focuses on the modifications to the core system and its software, not on a specific AI algorithm for diagnostic interpretation that would typically necessitate an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No specific standalone algorithm performance study is detailed. The described tests are for the overall system's functionality and safety, not for a distinct algorithm's diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated for diagnostic purposes. For engineering and software validation, ground truth would likely refer to system specifications, known inputs, and expected outputs, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set

• Not applicable/Cannot be provided. This document does not describe the development or evaluation of a machine learning model that would require a "training set." The software updates are described as functional enhancements and system improvements, not as new AI algorithms trained on specific datasets.

9. How the ground truth for the training set was established

• Not applicable/Cannot be provided. As above, no training set information is present.

In summary, the provided document is a regulatory submission focused on demonstrating the substantial equivalence of a modified imaging system (ARTIS icono (VE30A)) to a previously cleared predicate device (ARTIS icono (VE21)). It highlights engineering verification and validation, software testing, and compliance with performance and safety standards, rather than clinical performance studies of diagnostic accuracy or AI assistance.

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