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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 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 and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS pheno (VE21) system is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal, and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE21) system is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, available for the support of dedicated clinical workflows.

The ARTIS pheno (VE21) 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 floor 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, collimator, and imaging system

Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts.

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 pheno (VE21) 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 pheno (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

This document, K220409, concerns the Siemens Medical Solutions USA, Inc. ARTIS pheno (VE21) System, an image-intensified fluoroscopic X-ray system. The submission seeks to demonstrate substantial equivalence to the previously cleared ARTIS pheno (VE20) system. The modifications in the VE21 system include updated system software (from VE20 to VE21) to support NOMSIE DSA (IQ) customization of contrast in DSA images and an optional new generator (Polydoros ACX).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a summary of comparison of technological characteristics was performed. However, it does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it offers a qualitative statement about the testing results.

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

The document does not explicitly state the specific sample size (e.g., number of images, or patient cases) used for the test set for image quality or clinical performance evaluations related to the software updates.

Regarding data provenance, the document mentions "non-clinical tests" and "bench test summaries." The nature of these tests suggests they are primarily technical and engineering validations rather than studies involving patient data from a specific country of origin or a retrospective/prospective design. The modifications are described as "software and hardware changes [that] do not raise any new risks or any issues regarding the safety nor effectiveness of the device."

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

The document does not mention the use of experts or the establishment of ground truth for a test set in the context of the software or hardware modifications. The testing described focuses on technical compliance, verification, and validation, rather than clinical efficacy studies involving expert review of patient data.

4. Adjudication Method for the Test Set

Since there is no mention of a clinical test set requiring expert ground truth establishment, there is no adjudication method described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence through technical and functional testing of modifications rather than comparative clinical performance with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly describe a standalone performance study in the context of an algorithm's diagnostic accuracy without human intervention. The "NOMSIE DSA (IQ) Customization of Contrast in DSA images" is a software modification related to image quality customization, and its performance is assessed through verification and validation testing, not typically as an AI algorithm in a standalone diagnostic capacity as might be reported for a disease detection or quantification algorithm.

7. Type of Ground Truth Used

The "ground truth" for the testing performed appears to be based on:

• Engineering Specifications and Standard Compliance: For electrical safety, EMC, software functionality, and other technical aspects, ground truth is conformity to established industry standards (e.g., IEC 60601 series, IEC 62304) and internal product specifications.
• Verification and Validation Testing Results: The software specifications are considered met based on the outcomes of verification and validation tests.
• Risk Analysis: Ground truth for safety is established by mitigating identified hazards through risk control measures.

There's no indication of ground truth based on expert consensus, pathology, or outcomes data in the context of clinical diagnostic accuracy for an algorithm.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is consistent with the nature of the submission, which focuses on modifications to an existing device (ARTIS pheno VE20 to VE21) and the associated technical validation, rather than the development and training of a novel machine learning algorithm requiring a distinct training dataset.

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

Since no training set is mentioned for a new machine learning algorithm, there is no information provided on how ground truth for a training set would have been established.

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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 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 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 and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The ARTIS pheno (VE2) system is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE2) system is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, available for the support of dedicated clinical workflows.

The ARTIS pheno (VE2) 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.

1. The following components are configured to create the ARTIS pheno VE2 system: 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, collimator and imaging system.

Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts.

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 pheno (VE2) 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 pheno (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

The provided text is a 510(k) summary for the ARTIS pheno (VE2) system, which is an angiography system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a medical device's performance against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it would for a study proving a device meets a clinical performance claim (e.g., diagnostic accuracy of an AI algorithm). The information provided is about the safety and effectiveness of the updated angiography system in terms of hardware, software modifications, and compliance with general medical device standards.

Specifically, the document lists modifications to the ARTIS pheno (VE2) system, such as improved roadmap features, new marketing terminology, updated user interface, and hardware changes. It states that non-clinical performance testing was conducted to assess functionality and compliance with various electrical, safety, and performance standards. However, it does not present clear, quantifiable acceptance criteria or reported performance results in the format requested for a study proving device performance against specific clinical metrics.

Here's why the requested information cannot be extracted from this document:

• No specific clinical performance metrics: The document discusses improvements like "increased image quality dose ratio" and "Improved Image Quality due to improved algorithm" but without quantifiable acceptance criteria (e.g., "sensitivity > X%", "specificity > Y%", "AUC > Z%") or reported numerical results against such criteria.
• Focus on substantial equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is different from proving that a device (especially an AI-driven one making a new diagnostic claim) meets specific, pre-defined performance thresholds in a clinical study.
• No mention of AI algorithm performance: While there's talk of "improved algorithms" and "syngo DynaCT Multiphase," the document doesn't define or evaluate an AI algorithm in the way you'd expect for a device making a new AI-based diagnostic claim. It's about overall system improvements, not a groundbreaking AI diagnostic tool.
• Lack of test set details: There's no mention of a specific test set, its sample size, data provenance, or ground truth establishment for clinical performance evaluation of a new function (like an AI algorithm would require).
• No human reader studies: There is no mention of MRMC studies or human-in-the-loop performance evaluations.
• No training set details: Information about a training set for an AI algorithm (sample size, ground truth establishment) is absent.

Therefore, I cannot fulfill your request for the table and study details based on the provided text. The document describes a traditional medical device modification clearance, not a study validating an AI algorithm against specific clinical performance criteria.

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