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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 angtography, 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 pheno (VE30A) is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, and 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 (VE30A) 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, and available for the support of dedicated clinical workflows.

The ARTIS pheno (VE30A) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography, 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

lmages 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 (VE30A) is capable of 2D and 3D imaging.

Other systems and software synqo Application Software, syngo X Workplace, Sensis Vibe, and or third-party systems may also be integrated into the ARTIS pheno (VE30A) screen configuration. Different screen configurations and layouts are possible in the examination room and the control room.

The provided text describes modifications to an existing device, ARTIS pheno (VE21) to create ARTIS pheno (VE30A). The study is primarily a non-clinical performance evaluation focused on verifying that the changes introduced in VE30A do not negatively impact the safety and effectiveness compared to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of "acceptance criteria" alongside specific "reported device performance" values in a quantitative manner for most of the listed modifications. Instead, it generally states that "All testing results passed" and "All test results met all acceptance criteria" for various tests performed on the modifications.

However, based on the descriptions, we can infer some general acceptance criteria and the reported performance as "met" or "passed".

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

The document does not specify a quantitative sample size for any test set (e.g., number of images, number of patients, number of cases). The testing appears to be primarily focused on system-level verification and validation of the software and hardware modifications rather than a clinical study involving patient data.

• Test Set: Not explicitly stated as a distinct "test set" in the context of clinical data. The testing involved "software functional, verification, and System validation testing," "NOMSIE algorithm, overlay, configuration, vessel presentation DSA, and roadmap testing," and "CNR image Quality exposure control, fluoro auto exposes values cardiology, DR, CNR, DSA, and neuro testing." These are likely performed on test harnesses, simulated data, and potentially a limited number of test cases or phantoms.
• Data Provenance: Not applicable in the context of clinical data. The testing is non-clinical.

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

This information is not provided. Since the study is a non-clinical performance evaluation, it did not involve clinical experts establishing ground truth in the traditional sense for a diagnostic AI device. The "ground truth" for the non-clinical tests would be the expected functional and performance outcomes defined by engineering specifications.

4. Adjudication method for the test set

Not applicable. There is no indication of multiple readers or an adjudication method for establishing ground truth from human experts, as this was not a clinical study involving diagnostic interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an image-intensified fluoroscopic x-ray system, and the changes are related to system software, hardware, and workflow features, not a diagnostic AI component intended for human reader assistance.

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

The device itself is an imaging system. The "algorithms" mentioned (e.g., NOMSIE, Structure Scout) are integrated parts of the overall imaging functionality. While these algorithms perform specific tasks (like image quality enhancement, reconstruction, element identification), their "standalone" performance isn't described in isolation from the system's output. The performance evaluation is inherently within the context of the ARTIS pheno system. It's not an AI model providing a separate diagnostic output.

7. The type of ground truth used

The ground truth used for these non-clinical tests would be based on:

• Engineering specifications and requirements for software functionality.
• Expected image quality parameters (e.g., CNR for Structure Scout) as measured by phantoms or controlled test conditions.
• Defined operational workflows for usability features.
• Compliance with recognized standards for electrical safety, performance, and EMC.

It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The document describes modifications to an existing x-ray system, implying traditional software and hardware development and testing, not the training of a machine learning model from a distinct "training set" of data.

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

This information is not applicable and not provided as no machine learning training set is mentioned.

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 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.

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 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.

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.

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 is a further development of the Artis Q and Artis Q.zen -Modular Angiography System. ARTIS pheno is equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table, and image post processing. syngo Application Software is optional available for the support of dedicated clinical workflows.

The provided text describes the ARTIS pheno device and its substantial equivalence to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document states that "Non-clinical tests were conducted for ARTIS pheno, during product development" and that "The modifications described in this Premarket Notification were supported with verification and validation testing." It also mentions "The performance data demonstrates continued conformance with special controls for medical devices containing software" and "The testing results support that all the software specifications have met the acceptance criteria."

However, it does not provide the actual acceptance criteria or the specific numerical performance results achieved by the device in a table format. It only lists various standards the device complies with (e.g., ES60601-1:2005/(R)2012) and general statements about the tests being passed.

Therefore, I cannot populate the requested table or provide detailed answers to questions 2 through 9 based on the provided text. The document refers to "non-clinical performance testing" and "verification and validation testing" but does not elaborate on the specific methodologies, sample sizes, ground truth establishment, or expert involvement for these tests.

Summary of available information regarding performance:

• Acceptance Criteria/Reported Performance: Not explicitly stated in a quantifiable manner or table. The document generally states that "all tests were passed" and that "all the software specifications have met the acceptance criteria."
• Sample size for test set and data provenance: No information provided.
• Number of experts and qualifications for ground truth: No information provided.
• Adjudication method: No information provided.
• MRMC comparative effectiveness study: No information provided.
• Standalone (algorithm only) performance: No information provided the software is a component of the interventional fluoroscopic x-ray system, not a standalone AI device with specific algorithmic performance metrics.
• Type of ground truth used: "Non-clinical performance testing" and "software specifications" are mentioned, suggesting internal validation against defined functional requirements and safety standards. No mention of expert consensus, pathology, or outcomes data for performance evaluation in the context of diagnostic accuracy.
• Sample size for training set: No information provided.
• How ground truth for training set was established: No information provided.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, adherence to safety and performance standards for an interventional fluoroscopic x-ray system, and successful completion of verification and validation activities. It does not provide the kind of detailed study results one might expect for a novel AI/CAD device.

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