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

The ARTIS Family (VE40A) 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 physicians can navigate catheters and other devices safely. The ARTIS Family (VE40A) 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 Family (VE40A) modular angiography systems are designed as sets of components that may be combined into four different confiqurations (Biplane, Floor, Ceiling, or the ARTIS pheno) to provide specialized angiography systems. In general, they are equipped with a C-arm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing.

The ARTIS Family (VE40A) 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 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 Family (VE40A) system configurations, 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 Family (VE40A) Systems are capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor, the ceiling or ARTIS pheno. Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS Family (VE40A) screen configuration.

The provided document is a 510(k) Premarket Notification from Siemens Medical Solutions USA, Inc. for their ARTIS icono (VE40A) and ARTIS pheno (VE40A) angiography systems.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of specific acceptance criteria. Instead, it broadly states that "All test results met all acceptance criteria" and that "The testing results show that all the software specifications have met the acceptance criteria."

The performance testing primarily focuses on the safety and functional aspects of the updated software and a new hardware feature (Xpand).

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

The document does not explicitly state a specific "sample size" in terms of patient cases or images for the performance testing. The non-clinical performance testing described seems to be more about functional verification and validation of the software and hardware modifications rather than a study on a diagnostic dataset.

• Test Set Sample Size: Not specified. The description "XPAND - Ceiling Transversal Flow testing the steps the user performed to move the C-arm" suggests a functional test of the system's mechanics and software, likely involving engineers or test personnel, rather than a dataset of patient images.
• Data Provenance: The testing was "conducted for the ARTIS Family (VE40A)" by Siemens. It is internal non-clinical testing. No country of origin of patient data or retrospective/prospective nature is mentioned, as it does not appear to involve patient data.

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

Not applicable. The tests described are functional and verification tests for the software and hardware, not diagnostic performance studies requiring expert ground truth establishment on medical images.

4. Adjudication Method for the Test Set:

Not applicable. This was not a study requiring expert adjudication of medical image interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The document does not describe the device as incorporating AI, nor does it conduct any studies with human readers. The device is an image-intensified fluoroscopic X-ray system, and the changes are software updates and a mechanical feature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:

No, a standalone algorithm performance study was not explicitly described. While "Software functional, verification, and System validation testing were conducted with passing results," these relate to the functionality of the system's operating software and a new mechanical movement feature ("Xpand"), not an AI algorithm's diagnostic performance. The DynaCT (3D reconstruction) is mentioned as a software option, but no specific performance study of DynaCT as a standalone algorithm is detailed in this section of the submission. The changes outlined are updates to the overarching system software (VE30A to VE40A, and VE23 to VE40A).

7. The Type of Ground Truth Used:

For the functional and verification testing:

• Software Functionality: The ground truth would be the defined software specifications and requirements.
• XPAND Feature: The ground truth would be the engineering specifications for C-arm movement and positioning.
• Compliance with Standards: The ground truth is the requirements outlined in the various IEC, ISO, and other recognized standards.

8. The Sample Size for the Training Set:

Not applicable. This device, based on the provided document, does not appear to involve AI/ML technology that requires a training set in the conventional sense of machine learning for diagnostic tasks. The software updates are for the system's operational control and imaging capabilities, not for an algorithm that learns from data to perform a diagnostic function.

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

Not applicable, as there is no apparent training set for an AI/ML algorithm described in this document.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 (VE21) 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 (VE21) 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 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 manipulate the catheters or other devices during x-ray. X-ray release is table side via a footswitch.

The ARTIS icono (VE21), 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-ray tube, collimator, high voltage generator, patient table, and image post processing.

The ARTIS icono (VE21) 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 (VE21) 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 variaous 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 (VE21) 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, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.

The Subject device ARTIS icono with software version VE21 will support the following modifications.

The provided document is a 510(k) summary for the Siemens ARTIS icono (VE21) System, a medical device for angiography. It describes the device, its intended use, and its substantial equivalence to a predicate device (ARTIS icono VE20).

However, the document does not contain specific acceptance criteria, reported device performance metrics (numerical data like sensitivity, specificity, accuracy), or details of a study that directly prove the device meets acceptance criteria in the format requested.

It states that "All test results met all acceptance criteria" and mentions "Bench Test Summaries" but does not provide the details of these tests or criteria. It also does not include information about sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the specific type of ground truth used for performance evaluation on its new features (Lateral Plane syngo DynaCT and NOMSIE DSA).

The document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance, by detailing changes and adherence to various safety and performance standards.

Therefore, I cannot populate the table or provide the requested information completely as it is not present in the provided text.

Based on the provided text, here's what can be extracted and what is missing:

Information NOT present in the document for the specific modifications (Lateral Plane syngo DynaCT, NOMSIE DSA (IQ) Customization, Optional New Generator):

• Acceptance Criteria Table: Specific numerical acceptance criteria for the new features (e.g., image quality metrics like contrast-to-noise ratio, spatial resolution, or diagnostic accuracy for DynaCT).
• Reported Device Performance: Specific numerical performance data demonstrating how the device met these criteria for the new features.
• Sample Size for Test Set: Not mentioned for any specific performance evaluations of the new features.
• Data Provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of Experts & Qualifications: Not mentioned for establishing ground truth for any performance evaluations of the new features.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: No mention of an MRMC study or effect size for AI assistance.
• Standalone Performance Study: The document primarily discusses verification and validation of software and hardware changes, not a standalone performance study with clinical outcomes or diagnostic accuracy for the new features.
• Type of Ground Truth Used (for the new features): Not specified (e.g., gold standard, pathology, clinical outcome, expert consensus).
• Sample Size for Training Set: Not mentioned.
• How Ground Truth for Training Set was Established: Not mentioned.

Information that can be inferred or directly stated from the document (mostly related to general safety and validation, not specific performance metrics of new features):

• Study That "Proves" Device Meets Acceptance Criteria: The document states:
  • "Verification and Validation: Software Documentation for a Major Level of Concern software per FDA's Guidance Document... is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ARTIS icono System software (VE21) during product development."
  • "The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
  • "ARTIS icono System software (VE21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual."
  • "Performance tests were conducted to test the functionality of ARTIS icono (VE21) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness."
  • "The modifications described in this Premarket Notification are supported with verification and validation testing."

Summary Table (with placeholders for missing information):

Ask a specific question about this device

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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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 X-ray 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 soft tissues as well as other internal body structures for 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 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 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 C-arm, stand, flat panel detector, x-ray 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, and radiographic/fluoroscopic procedures.

The provided text describes the Siemens ARTIS icono (VE2) angiography system, which is a medical imaging device used for diagnostic and interventional procedures. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document details numerous product claims (Table 3), which serve as acceptance criteria for specific features and performance aspects of the ARTIS icono (VE2). The "Comparison Results" in Table 5 also refer to specific testing (Bench Testing, System Validation testing) supporting these claims.

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