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Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis family include cardiac angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.

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 systems include also the software option DynaCT with following IFU:

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 Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software.

Siemens currently markets the Artis zee / zeego (K141574) and the Artis Q / Q.zen (K123529). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen (K123529). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality.

Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.

The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions.

This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 (K141574) and Artis Q / Q.zen SW Version VD10 (K123529). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."

The provided document does not contain the detailed acceptance criteria and performance study outcomes typically found in a clinical or standalone performance study report for AI-powered diagnostic devices.

Instead, this document is a 510(k) summary for Siemens Medical Solution USA, Inc.'s Artis zee/zeego & Artis Q/Q.zen angiographic X-ray systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for hardware and software modifications, rather than evaluating a novel AI algorithm's diagnostic performance against ground truth.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

Acceptance Criteria and Device Performance

• No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) are provided for an AI component.
• The document mentions "acceptance criteria" in the context of verification and validation testing for the software specifications and that "all software specifications have met the acceptance criteria," but these criteria are not detailed in terms. This likely refers to system-level tests for functionality, safety, and effectiveness of the updated X-ray system software, not a diagnostic performance metric.

Study Details (as far as can be inferred/is absent)

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

   • Absent. There is no table detailing acceptance criteria for diagnostic performance or reported performance metrics like sensitivity, specificity, or F1-score for any AI component. The document discusses regulatory standards compliance and software verification/validation, but not diagnostic accuracy.

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

   • Absent. The document does not describe a test set in the context of diagnostic performance evaluation for an AI algorithm. It refers to "non-clinical test data" and "clinical images and data" used for evaluating the predicate devices, but doesn't specify a test set for the modifications or an AI component.

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

   • Absent. No information is provided regarding expert readers or ground truth establishment for a test set, as no diagnostic performance study for an AI algorithm is described.

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

   • Absent. Not applicable, as there's no mention of a diagnostic test set for an AI algorithm.

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:

   • Absent. There is no mention of an MRMC study or any evaluation of human reader improvement with AI assistance. The submission is about modifications to an X-ray imaging system, not an AI diagnostic tool.

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

   • Absent. No standalone AI algorithm performance study is indicated.

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

   • Absent. No ground truth type is specified, as no diagnostic performance study is detailed.

8. The sample size for the training set:

   • Absent. There is no mention of a training set, indicating that this submission is not for an AI/ML algorithm that requires training. The "DynaCT" software option mentioned is for 3D reconstruction from 2D images, not a learned diagnostic pattern recognition system in the sense of modern AI/ML.

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

   • Absent. Not applicable, as no training set is mentioned.

Summary of What the Document Does Provide:

The document is a 510(k) submission for modifications to existing angiography systems. The modifications primarily involve:

• Revised Indications for Use (clarification, not new uses).
• New software version (VD11D) to support hardware.
• Support for an existing detector (Pixium 3040CV) on an additional system (Artis zee/zeego).
• A new tube cooling unit.
• Updated product claims.
• Configuration updates for the "Miyabi Angio-CT" (now "nexaris Angio-CT"), including improved collision calculation.

The regulatory review concluded that the device is "substantially equivalent" to predicate devices, based on:

• Non-clinical tests for electrical safety, performance, electromagnetic compatibility, and compliance with various international standards (listed in Table 3 on page 10).
• Software verification and validation testing, addressing the FDA's guidance documents for software in medical devices and cybersecurity. These tests demonstrated that the software modifications met acceptance criteria and did not raise new safety or effectiveness issues.
• Human Factors Usability Validation.

Key Missing Information: This document is NOT about an AI-powered diagnostic device in the modern sense that would require performance metrics like sensitivity, specificity, or a comparison against a human expert ground truth. It focuses on demonstrating the safety and effectiveness of updated hardware and software components within an imaging system.

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Artis zee / zeego 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 zee / zeego family include cardiac angiography, general angiography. rotational angiography, multipurpose angiography and whole body radiographic fluorossopic 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 zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a Carm CBCT functionality.

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.

Artis zee / zeego Modular Anqiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. This submission contains Quantitative CARE claims to be added.

The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems. All components are described in the Device Description Section 10 and the Substantial Equivalence Section 11.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a new device meets these criteria in the typical sense of a clinical or performance study with defined statistically significant endpoints.

Instead, this document is a 510(k) summary for a Siemens Artis zee/zeego angiography system (software version VC21), where the manufacturer is claiming substantial equivalence to previously cleared predicate devices. The core of the submission is to justify that the "Quantitative CARE claims" for this system are substantially equivalent to those cleared in a different system (Artis Q and Artis Q.zen).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert adjudication, or MRMC studies for a new device's performance because this information is not present in the provided text. The document focuses on regulatory compliance and equivalence to existing devices, not a de novo performance study.

However, I can extract the relevant information regarding the type of evaluations performed and the basis for the substantial equivalence claim:

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

This information is not explicitly provided in the format of a clinical performance table with specific acceptance criteria and corresponding reported statistical performance metrics. Instead, the document states:

"The Artis zee / zeego Modular Angiography System with the Quantitative CARE claims is the same Angiography System cleared in 510(k) K122644 with the addition of CARE Claims cleared in 510(k) K123529 the Artis Q and Artis Q.zen Modular Angiography systems."

And, regarding non-clinical testing:

"The testing results supports that all software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence."

This implies that the acceptance criteria are met by demonstrating the updated system functions as expected and consistent with the predicate devices, and that the "Quantitative CARE Claims" perform similarly to how they performed on the Artis Q and Q.zen systems. Specific numerical performance metrics for these claims are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document focuses on showing that the new device (Artis zee/zeego with VC21 and CARE claims) is substantially equivalent to legally marketed predicate devices, not on a new clinical study. The non-clinical testing mentioned refers to "integration and functional" software tests, not typically requiring a clinical test set with patient data or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document does not describe a clinical study where experts established ground truth for a test set.

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

This information is not provided. No expert adjudication method 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 MRMC comparative effectiveness study is mentioned. The device is not described as an AI-assisted device for human readers.

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

The document does not describe a performance study for a standalone algorithm. The device is a complete angiography system. The "Quantitative CARE claims" imply automated measurements or optimizations, and the non-clinical testing confirmed "all software specifications have met the acceptance criteria," but specific standalone performance metrics are not given.

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

This information is not explicitly stated. Given that the submission is for substantial equivalence and involves "Quantitative CARE Claims," the ground truth for validating these claims would likely have been established during the development and clearance of the predicate Artis Q and Q.zen systems. This would typically involve comparison to established methods or gold standards for quantitative measurements in angiography. However, details are not in this summary.

8. The sample size for the training set

This information is not provided. The document describes software modifications and the addition of previously cleared "CARE Claims" to an existing system, not the development of a de novo algorithm requiring a training set.

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

This information is not provided, as the concept of a "training set" in the context of this 510(k) submission is not applicable.

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Artis zee / zeego 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 zee / zeego family include cardiac angiography, neuroangiography, 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 X-ray imaging, surgery and interventions

Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.

The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a C-arm CBCT functionality.

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 zee/zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. A new Flat Panel detector has been added to the systems.

The Artis zee / zeego Modular Angiography System with the new Flat Panel detector is substantially equivalent to the AXIOM Artis Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.

The provided text is a 510(k) summary for a medical device (Artis zee/zeego with CSX-10 Detector SW VC21), which is a regulatory submission to the FDA. It declares substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Artis zee, Artis zeego SW VC14, K090745) rather than establishing and reporting against new performance acceptance criteria for the modified device.

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

This information is not provided. The submission details modifications to an existing system, including a new flat panel detector. It doesn't describe a specific "test set" in the context of clinical performance evaluation for acceptance criteria.

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

This information is not provided. As no specific study with a "test set" and ground truth establishment is detailed, this is not applicable here.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC comparative effectiveness study is mentioned. The document primarily focuses on technological characteristics and substantial equivalence, not comparative clinical effectiveness.

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

This device is an angiography system with a new detector, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable in this context. The document describes a medical imaging system that produces images for human interpretation.

7. The Type of Ground Truth Used:

This information is not provided. No specific "ground truth" is described in the context of device performance evaluation. The device is intended to produce images for diagnostic, surgical planning, interventional procedures, and treatment follow-up, implying that the output (images) would be interpreted by healthcare professionals.

8. The Sample Size for the Training Set:

This information is not provided. The device is an imaging system, not an AI system that undergoes "training."

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

This information is not provided. This concept is not applicable to the type of device described.

Summary of Information from the Provided Text:

The document is a 510(k) submission, specifically a "510(k) Summary," which aims to demonstrate that a modified device (Artis zee/zeego with CSX-10 Detector SW VC21) is "substantially equivalent" to a legally marketed predicate device (Artis zee, Artis zeego SW VC14).

• Device Name: Artis zee/zeego with CSX-10 Detector SW VC21
• Predicate Device: Artis zee, Artis zeego SW VC14 (K090745, cleared June 18, 2009)
• Basis for Equivalence: The document states that the new device is a modification of the predicate device, primarily adding a new Flat Panel detector. It asserts that the functionality and indications for use are similar.
• Safety and Effectiveness Concerns: Siemens states that instructions for use are included, risk management is ensured via hazard analysis and V&V testing, and adherence to recognized industry practices minimizes electrical, mechanical, and radiation hazards. Operators are expected to be healthcare professionals.
• Conclusion: Siemens states that the Artis zee/zeego Modular Angiography System with the new detector is substantially equivalent to the predicate device because it has the same indication for use and similar functionality.

The 510(k) process typically relies on demonstrating equivalence to an already cleared device, potentially through performance differences that do not raise new questions of safety and effectiveness, rather than a detailed study against specific, novel acceptance criteria as might be expected for entirely new technology or PMA submissions.

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