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The syngo Application Software is a medical software for real-time viewing, image manipulation, 3Dvisualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and postprocessing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens Healthineers Angiography system family.

It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available postprocessing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" is medical diagnostic software for real-time viewing, diagnostic review, post-processing image manipulation, communication, reporting, and storage of medical images and data on exchange media. It provides imageguided solutions in the operating room, for image-quided surgery, by Image Fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows-based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

The provided document describes a 510(k) submission for the "syngo Application Software," which is a modification (VE40C) of a previously cleared device (VE30A). The submission focuses on demonstrating substantial equivalence to the predicate device through non-clinical performance testing and software verification and validation.

However, the document does not contain the detailed breakdown of acceptance criteria and reported device performance in the format requested. Specifically, there is no table presenting quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported performance metrics. The document states that "All test results met all acceptance criteria" and "All conducted test results passed," but it does not specify what those criteria were.

Furthermore, information regarding sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance details, type of ground truth used, training set sample size, and ground truth establishment for the training set is not present in the provided text. The submission focuses on software changes and their verification, rather than clinical performance studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted or inferred, and what is missing:

Acceptance Criteria and Study Details (Based on available information):

• "All test results met all acceptance criteria."
• "All software validation data demonstrates that the Subject device is as safe and effective when compared to the Predicate Device... All test results met all acceptance criteria."
• "The testing results support that all the software specifications have met the acceptance criteria."
• "The results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness."
• "In summary, All conducted test results passed."
  This indicates that internal functional and technical acceptance criteria were met for the software updates, but specific performance metrics for diagnostic accuracy or clinical effectiveness are not detailed. |
  | 2. Sample size for the test set and data provenance | Not specified. The document mentions "Bench Test Summaries" for the updated syngo Biplane 3D Roadmap feature, and verification/validation testing for software functionalities, but does not provide details on data sources (e.g., number of cases/images) or provenance (country of origin, retrospective/prospective). |
  | 3. Number of experts used to establish ground truth and their qualifications | Not applicable/Not specified. The testing described is primarily software verification and validation, and non-clinical performance (bench testing) related to the functional changes, rather than clinical accuracy requiring expert ground truth. |
  | 4. Adjudication method for the test set | Not applicable/Not specified. As the testing is not described as involving diagnostic interpretation leading to a "truth" panel, adjudication methods are not mentioned. |
  | 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. The document does not describe an MRMC study or any comparison of human reader performance with and without AI assistance. The device is software for image management, processing, and guidance; it's not described as an AI-powered diagnostic aid that would typically undergo such a study. |
  | 6. Standalone (algorithm only without human-in-the-loop performance) study | Partially applicable, but for functional/technical performance, not diagnostic accuracy. The "Nonclinical Performance Testing" and "Software Verification and Validation" sections describe tests conducted on the software itself to ensure its functionalities (like myNeedle Guide steps, Biplane 3D Roadmap features) perform as intended. These are standalone tests in the sense that they evaluate the software's technical operation. However, the document does not present "standalone" performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) as would be relevant for an AI diagnostic device. The evaluation is against software specifications and safety/effectiveness relative to the predicate. |
  | 7. Type of ground truth used | Not applicable/Not explicitly stated for clinical ground truth. The testing appears to be based on software specifications and functional correctness rather than clinical ground truth (e.g., pathology, outcomes data). For instance, for "Updated myNeedle Guide testing," the "ground truth" would be whether the software correctly executes the described steps (Biplane-Couple-A-B, Invoke Progress Needle Step, etc.) according to technical requirements. |
  | 8. Sample size for the training set | Not specified. The document does not mention any training sets, suggesting the changes are primarily functional updates to existing software rather than the introduction of new machine learning algorithms requiring explicit training data. |
  | 9. How the ground truth for the training set was established | Not applicable. No training set is mentioned. |

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is primarily a non-clinical performance testing and software verification and validation process for software updates to the existing "syngo Application Software." The focus is on demonstrating that the modified software (VE40C) maintains the safety and effectiveness of the predicate device (VE30A) and that the new functionalities operate correctly according to their technical specifications.

The testing involved:

• Software Verification and Validation: Adhering to FDA's "Guidance for the Content of Premarket Submissions for Device Software Functions" (Basic Level of Concern) and "Off-The-Shelf Software Use in Medical Devices." This includes risk analysis and control implementation.
• Bench Testing Summaries: Conducted for the specific new features.
  • Updated myNeedle Guide testing: Encompassed scenarios like Biplane-Couple-A-B, Invoke Progress Needle Step messages, and switch-off drive functionalities.
  • Updated syngo Biplane 3D Roadmap testing: Encompassed features like overlaying internal datasets, overlaying contours, alternative flow, 2D/2D 3D Registration OV Basic Flow Overlay Assist, Set Active Plane, and Biplane Registration Modes Segment Selection.
• Human Factor Usability Validation: Showed no safety-relevant functions requiring summative validation.
• Cybersecurity Compliance: Conformance to IEC 80001-1:2010.

The document asserts that "All test results met all acceptance criteria" and "All conducted test results passed," and that the software validation data demonstrates the subject device is as safe and effective as the predicate. The "acceptance criteria" appear to be internal software specifications and functional requirements validated through these non-clinical tests. This type of submission is common for software updates that do not introduce novel clinical functionalities but rather refine or add features to existing cleared software.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review. postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available postprocessing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" (VE30A) is medical diagnostic software for realtime viewing, diagnostic review, post-processing image manipulation, optimization, communication, reporting, and storage of medical images and data on exchange media. It provides image-quided solutions in the operating room, for image-guided surgery, by Image Fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology, and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows-based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VE30A) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

Based only on the provided text, here is an analysis of the acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a software update. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, de novo clinical study with detailed performance metrics against acceptance criteria for a novel AI algorithm. Therefore, much of the requested information (like specific AI performance metrics, MRMC studies, or detailed ground truth establishment for a large test set) is not present in this type of regulatory document. The "tests" described are primarily software verification and validation, and functional testing to ensure the new features perform as expected and do not introduce new safety issues.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance (e.g., specific accuracy, sensitivity, specificity thresholds for an AI algorithm). Instead, the acceptance criteria are generally framed around software verification and validation, and functional performance of the new features to ensure they are "as safe and effective" as the predicate device.

Implicit Acceptance Criteria and Reported Performance:

Study Details:

1. Sample sizes used for the test set and data provenance:

   • The document implies that "Bench Test Summaries" were conducted and "Software Verification and Validation" was performed, but it does not specify the sample size (e.g., number of images, patients, or cases) of the test set used for these evaluations.
   • The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It only mentions compliance with standards and internal testing.

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

   • The document does not specify the number or qualifications of experts used to establish "ground truth" for any test set. The testing described appears to be functional and software verification, not clinical performance against expert-defined ground truth in the traditional sense of a diagnostic AI study.

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

   • The document does not mention any adjudication method for establishing ground truth for a test set. This type of detail is typical for studies evaluating diagnostic accuracy, which is not the primary focus of this software update K230955 submission as presented.

4. 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 was done or reported in this document. The submission is for a software update to an existing device, focusing on functional performance and substantial equivalence, not a comparative clinical effectiveness study of an AI-assisted diagnostic tool.

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

   • The document describes "non-clinical performance testing" and software verification and validation. This type of testing would be considered "standalone" in the sense that the software's functionality is directly assessed (e.g., "The updated syngo Embolization Guidance feature for Radial Access was tested for availability and basic flow to create and detect vessels."). However, it is not a standalone diagnostic performance study in terms of an algorithm providing a diagnosis without human input. The device's purpose is "to assist the physician in the diagnosis, treatment planning, and treatment control."

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

   • The document does not specify a type of ground truth in the context of diagnostic accuracy (e.g., pathology, outcomes data, expert consensus). The "ground truth" implicitly referred to is the expected functional behavior and correct output of the software features based on their design specifications, which are verified through various internal tests.

7. The sample size for the training set:

   • The document does not mention a training set or its size. This is understandable as the submission is for a software update with specific functional enhancements, rather than the development and validation of a new machine learning algorithm.

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

   • As no training set is mentioned, information on how its ground truth was established is not provided.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed includes minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" (VE21) is medical diagnostic software for realtime viewing, diagnostic review, post processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VE21) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

This document describes the syngo Application Software (VE21), which is a medical software for viewing, manipulating, and storing medical images. The submission is for an updated version (VE21) which includes an updated feature called syngo TrueFusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative format for the syngo Application Software (VE21). Instead, it describes functional changes and verification that these changes meet expected behavior.

The key acceptance criteria and reported performance for the updated syngo TrueFusion feature are described as follows:

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

The document does not provide a specific sample size for the test set used for the updated syngo TrueFusion feature. It mentions "Bench tests were conducted" and "The following test were conducted...: Overlay Images Volume and Overlay Image Change Stand X-ray." but does not quantify the number of cases or images tested.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given that it refers to "Bench tests" and "software validation data," it implies internal testing rather than a clinical study with patient data.

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

The document does not mention the use of experts or the establishment of ground truth by experts for the test set. The validation appears to be based on functional testing against predefined specifications and clinical workflow expectations, rather than a diagnostic accuracy study needing expert-labeled ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there's no indication of a diagnostic accuracy study involving multiple readers and a ground truth establishment process.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on the functional updates of existing software and claims substantial equivalence to the predicate device based on non-clinical performance and software validation. There is no information about human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The testing described (bench tests, software validation) focuses on the syngo Application Software (VE21) as a standalone software product's functionality in performing its specified tasks (e.g., image overlay). While it's software for human interpretation and use in interventional procedures, the performance testing discussed is of the software's functionality itself, rather than an AI algorithm's diagnostic performance in isolation on a set of cases. The document does not describe specific "algorithm-only" performance metrics in the context of, for example, a diagnostic AI.

7. The Type of Ground Truth Used

The ground truth for the functional testing appears to be based on predefined software specifications and expected clinical workflow behavior. The document states, "The test results passed and concluded that the synqo TrueFusion image overlay functionality corresponds to the clinical workflow..." This implies that the software's output was compared against what is considered correct and clinically acceptable by the developers based on internal standards and design. There is no mention of pathology, expert consensus on patient cases, or outcomes data as ground truth.

8. The Sample Size for the Training Set

The document describes an updated software feature for an existing application. It does not refer to the development or training of a new AI model with a distinct training set. If there are underlying machine learning components within syngo TrueFusion (which isn't explicitly stated but could be inferred from image fusion), the sample size for any training data is not provided. The focus is on the verification and validation of the software update itself.

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

Since there is no mention of a distinct training set or an AI model training process, there is no information on how its ground truth might have been established. The submission focuses on verifying the functional correctness of software updates rather than the performance of a newly trained AI model.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diaming and treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

The "syngo Application Software" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VE2) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems.

Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission.

The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. The "syngo Application Software" (VE2) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remains the same.

The document describes the Siemens "syngo Application Software" (VE2) and its new optional software features: syngo DynaCT Sine Spin, syngo DynaCT Multiphase, and syngo Embolization Guidance. The submission aims to demonstrate substantial equivalence to the predicate device, "syngo Application Software" (VD20) (K173611).

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

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

The document doesn't provide a specific table with distinct "acceptance criteria" against which quantitative "reported device performance" is measured in a typical clinical trial format (e.g., Sensitivity X, Specificity Y). Instead, the acceptance is based on demonstrating that the new features are as safe and effective as the predicate device. The performance is reported through the results of bench testing and software validation, confirming the functionality and safety of the new features.

The core acceptance criterion is implicit: The new features ("syngo DynaCT Sine Spin", "syngo DynaCT Multiphase", and "syngo Embolization Guidance") must perform as intended, produce equivalent or improved image quality/functionality compared to the predicate, and not introduce any new issues of safety or effectiveness.

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

The primary testing presented involves bench testing and phantom studies. For the "syngo Embolization Guidance" a "study of randomly selected clinical cases" was performed, but the sample size is not specified. The document does not provide details on data provenance (country of origin) or whether the clinical cases were retrospective or prospective. It appears that the clinical case study for Embolization Guidance was not the primary means of validation for this 510(k), as it focuses on demonstrating safety and effectiveness mainly through non-clinical methods.

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

The document does not specify the number or qualifications of experts used to establish ground truth for any part of the test set. For the "syngo Embolization Guidance" clinical case study, it states the algorithm was "validated," implying comparison to some form of truth, but details are absent. For bench and phantom tests, ground truth would naturally be established by the physical properties of the phantoms/test setups.

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

The document does not describe any adjudication method for the test set. Given the nature of the validation (bench testing, phantom studies, and an unspecified clinical case study), a formal multi-reader adjudication process for establishing ground truth is not explicitly mentioned or implied.

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 described in the provided text. The submission focuses on demonstrating substantial equivalence of the software features themselves, not on the improvement of human reader performance with AI assistance. The device is a "Picture Archiving and Communications System" with features to assist physicians in image viewing and post-processing, not an AI diagnostic aid that directly impacts human reader interpretation.

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

Yes, the testing primarily focuses on the standalone performance of the algorithms and software features themselves through bench tests and phantom studies. For example, the image quality metrics (homogeneity, spatial resolution, CNR, etc.) are objective measures of the algorithm's output. The validation of the "syngo Embolization Guidance" feeder detection algorithm is also an assessment of its standalone accuracy, even if comparing against clinical cases.

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

• For syngo DynaCT Sine Spin and syngo DynaCT Multiphase: Ground truth for image quality and physical properties (e.g., homogeneity, spatial resolution, CNR, geometric distortion, z-direction resolution) would be established by the known physical properties of the phantoms and the design specifications of the system.
• For syngo Embolization Guidance: The feeder detection algorithm was "validated in a study of randomly selected clinical cases." This implies comparison to clinical ground truth, which for feeder vessels is typically established through expert review of angiographic images or potentially confirmed by intervention outcomes, though the document does not specify the exact nature of this clinical ground truth.

8. The sample size for the training set

The document does not mention a training set size. This might be because the changes are primarily functional enhancements to existing software features rather than completely new AI algorithms that require extensive training data. It states the "algorithm was not changed" for syngo Embolization Guidance, implying it was pre-existing.

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

Since no training set is explicitly mentioned or described, the method for establishing its ground truth is not provided.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

The "syngo Application Software" is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image-quided solutions in the operating room, for imageguided surgery, by Image Fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows-based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VD20B) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages, and basic services is the same as used with the "syngo Application Software" (VD20B) K170747 with exception of the added software options "Instant Fusion" and "Common Patient Registration". The new optional software features are only possible in an angiography (ARTIS Family) and CT (SOMATOM CT Sliding Gantry) systems configuration known as "nexaris Angio-CT".

"Instant Fusion" and "Common Patient Registration" is the subject of this submission. These features seamlessly integrate Angio and CT together and facilitate combined use. The "Instant Fusion" is an overlay of CT datasets to the Angiography image. The overlay is a position based registration of the CT gantry. The "Common Patient Registration" is the patient data transfer from "syngo Application Software" to the CT system using a communication interface.

This document is a 510(k) summary for the syngo Application Software (VD20B) by Siemens Medical Solutions USA, Inc. The submission requests clearance for two new optional software features: "Instant Fusion" and "Common Patient Registration." The study presented is a non-clinical performance test comparing the subject device (VD20B) with its predicate device (VD20A, K170747).

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria in terms of successful verification and validation testing, confirming that the new features ("Instant Fusion" and "Common Patient Registration") function as intended and do not raise new issues of safety or effectiveness. The reported device performance indicates these criteria were met.

• "Common Patient Registration" successfully transfers patient data automatically from the Angiography system to the syngo Application Software and the CT system. | - "Instant Fusion": "Measurements were performed with CT images to the interface simulator. The tests showed that CT images can be directly overlaid without additional 2D/3D registration."
• "Patient Registration": "Measurements were performed with different patient images to the interface simulator. The tests showed that the Patient data is automatically transferred after Patient registration on the Angiography system." |
  | Safety and Effectiveness | - No new issues of safety or effectiveness are raised compared to the predicate device.
• Conformance to relevant medical device standards (e.g., ISO 14971, IEC 60601-1-6, IEC 62304, IEC 62366-1, IEC 80001-1). | - "Results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness."
• "All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use."
• Conformance claims made for the listed standards in section 8. |
  | Risk Management | Risks identified and mitigated; testing results support meeting acceptance criteria. | "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." |
  | Human Factors/Usability | No safety-relevant functions requiring summative usability validation. | "The Human Factor Usability Validation showed no safety-relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines." |
  | Cybersecurity | Compliance with cybersecurity requirements, including prevention of unauthorized access/misuse. | "Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access… Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010." |

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

The document does not explicitly state a numerical sample size for the test set of "Instant Fusion" or "Common Patient Registration." It refers to "measurements were performed with CT images" and "measurements were performed with different patient images," implying a set of images/data was used, but the quantity is not specified.

The data provenance is not explicitly mentioned as retrospective or prospective, nor is a country of origin provided for the data used in validation testing. However, given it's a non-clinical performance test for software features, the data would likely be generated in a controlled environment as part of product development and verification.

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

The document does not mention the use of experts to establish ground truth for the software's functional validation. The testing described appears to be technical verification against predefined software specifications and functional requirements rather than a clinical evaluation requiring expert consensus on diagnostic accuracy.

4. Adjudication Method for the Test Set

Since the validation involved technical performance testing of software features (overlay and data transfer), rather than a diagnostic accuracy study with ambiguous cases, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned. The "ground truth" here is the system's intended technical function as defined by its specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done or reported. The submission focuses on the technical functionality and safety/effectiveness equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.

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

The performance testing described ("Instant Fusion" overlay and "Patient Registration" data transfer) represents a standalone algorithm performance evaluation in terms of its technical functionality. The tests assessed whether the software features performed their designated tasks (image overlay, data transfer) correctly as programmed, independent of human interpretation or interaction during the measurement itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the testing of "Instant Fusion" and "Common Patient Registration" appears to be the software's predefined functional specifications and technical requirements. For "Instant Fusion," the ground truth is the successful direct overlay of CT images via position-based registration. For "Patient Registration," the ground truth is the automatic and correct transfer of patient data.

8. The Sample Size for the Training Set

The document is a 510(k) summary for software features within an existing "syngo Application Software." It does not mention any training set size, which suggests that these features are likely rule-based or deterministic algorithms (for image overlay and data transfer) rather than machine learning or AI models that would require a distinct training phase with a labeled dataset.

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

Since no training set is discussed or implied for these specific software features (as they appear to be deterministic functions), the concept of establishing ground truth for a training set is not applicable here.

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The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" (VD20) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image-guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image quided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VD20) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the "syngo Application Software" (VD20) cleared in K163285 with the exception of the added new software feature "syngo TrueFusion".

The provided document describes the acceptance criteria and a study proving that the "syngo TrueFusion" software feature, added to the "syngo Application Software" (VD20), meets these criteria.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for "syngo TrueFusion"

Experiment 2: Position A: 2.76mm, Position B: 2.57mm, Position C: 2.13mm |
| Standard Deviation (for Mean) | Shall not exceed 2mm | Experiment 1: Position A: 1.29mm, Position B: 1.50mm, Position C: 1.62mm

Experiment 2: Position A: 1.31mm, Position B: 1.69mm, Position C: 1.48mm |
| Clinical Acceptance | N/A (Implicit in achieving metrical criteria) | All results were clinically accepted by a board certified cardiologist. |

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

• Sample Size: 28 phantom test data sets.
• Data Provenance: The document does not specify the country of origin. It indicates the data was generated from "phantom test data sets," which are typically controlled, lab-based experiments. It is a retrospective analysis of this phantom data.

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

• Number of Experts: One (1) board certified cardiologist.
• Qualifications of Experts: The document states "a board certified cardiologist" performed the measurements and clinically accepted the results.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). It states that the measurements were performed from different directions by "a board certified cardiologist" and "All results were clinically accepted by a board certified cardiologist." This suggests a single expert's assessment was used to clinically validate the numerical results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The study focuses on the technical performance of the "syngo TrueFusion" feature in a phantom setting (mean deviation and standard deviation) and its clinical acceptance by a single expert. It does not evaluate human reader improvement with or without AI assistance.

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

• Yes, the performance metrics (mean deviation and standard deviation) appear to be a standalone evaluation of the algorithm's accuracy in co-registration on phantom data. While a cardiologist "performed multiple measurements" and "clinically accepted" the results, the core performance metrics are objective measurements of the algorithm's output against implied ground truth on the phantom. This is an evaluation of the software's inherent performance.

7. The Type of Ground Truth Used

• The ground truth was established by phantom measurements. The acceptance criteria are based on the deviation from some reference or true value on the phantom, and those measurements were clinically accepted by a board-certified cardiologist.

8. The Sample Size for the Training Set

• The document does not specify a sample size for a training set. The study pertains to the validation of a new software feature, "syngo TrueFusion," which includes "probe detection enhanced by machine learning" (Claim 8). However, it only details the test data used for validation (28 phantom test data sets) and does not provide information about the data used for training the machine learning component.

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

• Since the document does not specify a training set, it does not describe how ground truth for the training set was established.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syneo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The syngo Application Software is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens syngo Application Software is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the syngo Application Software cleared in K162541.

Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance for new software features to the syngo Application Software.

Proposed Device Modifications:

• 1. Enhanced syngo Embolization Guidance
• 2. Proposed new product claims associated with device.

The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens Angiography Systems. The combination of syngo Application Software and the Siemens released PC Hardware will be marketed as components of the syngo X Workplace.

The syngo Application Software is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System.

The document provided is a 510(k) premarket notification for the "syngo Application Software," specifically focusing on enhancements to the "syngo Embolization Guidance" feature. While the document mentions performance testing and results, it does not detail acceptance criteria with specific thresholds or a formal study design that would typically contain all the requested information for a comprehensive study proving the device meets acceptance criteria.

However, based on the provided text, we can glean some information regarding the performance evaluation of the syngo Embolization Guidance algorithm. The primary focus of the performance data section is on the detection rate of vessels, specifically in the context of embolization guidance for hepatic arteries.

Here's an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a table format with clear threshold values for key performance metrics. It only provides reported performance metrics related to the syngo Embolization Guidance algorithm. The implicit acceptance criterion would be that the performance is "clinically accepted by a board certified radiologist."

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The syngo Application Software is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens syngo Application Software is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the syngo Application Software (K153346).

The document provides information on the Siemens syngo Application Software, which is an update to a previously cleared device. The focus of the provided text is on demonstrating the substantial equivalence of the updated software features to the predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are generally described as "clinically accepted" and that "all acceptance criteria have been met." The reported device performance is qualitative, focusing on whether the updated automated features raise new issues of safety or effectiveness.

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

The document does not specify a distinct "test set" with a particular sample size or data provenance (country of origin, retrospective/prospective). The evaluations seem to be part of the overall "Verification and Validation" process conducted during product development. The statement "All results are clinically accepted by either a board certified cardiologist or radiologist" suggests that clinical data was involved, but the specifics are not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document states: "All results are clinically accepted by either a board certified cardiologist or radiologist." This indicates that at least two experts (a cardiologist and a radiologist) were involved in evaluating the results. Their qualification is "board certified." The document does not specify how many individual experts were consulted or if specific experience levels (e.g., "10 years of experience") were required beyond board certification.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth for a test set (e.g., 2+1, 3+1). The phrase "clinically accepted by either a board certified cardiologist or radiologist" suggests an expert review process, but the specific decision-making protocol is not detailed. It's possible that consensus was reached, or individual expert opinions were considered sufficient for acceptance.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The focus is on the performance of the software updates themselves and their safety and effectiveness compared to the predicate device, not on their impact on human reader performance.

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

The document implies a standalone evaluation of the algorithm's performance as part of the "Verification and Validation testing." The descriptions of "Automatic segmentation of the aorta and vessel tree," "Automatic centreline extraction," and "Automatic model-based LA segmentation" suggest that the algorithmic output was assessed directly. However, it's not explicitly stated as a separate "standalone study." The acceptance criteria focus on whether these automated features raise new safety or effectiveness issues, which inherently involves evaluating their output.

7. Type of Ground Truth Used

The ground truth appears to be expert consensus/clinical acceptance. The statement "All results are clinically accepted by either a board certified cardiologist or radiologist" points to human expert interpretation as the basis for assessing the software's output. There is no mention of pathology or outcomes data being used as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for the updated software features.

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

The document does not provide any information on how the ground truth for the training set was established for the updated software features.

Ask a specific question about this device

The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software VD11 can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The syngo Application Software VD11 is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image quided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens syngo Application Software VD11 is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the syngo X Workplace (K143319).

The Subject Device is a modified version of the previously cleared syngo X Workplace software version VD10 cleared under Premarket Notification K143319 on February 24, 2015.

The following modifications are made to the cleared syngo X Workplace software version VD10 which created the Subject Device:

• 1. Updated Indications for Use Statement (Modification Affects: Labeling)
• 2. VD10 Software renamed to VD11 (VD10 software features of the predicate device remain the same). The "syngo Application Software" VD11 consists of features cleared as SW Version VD10 in K143319. VD11 is provided as software only on a CD/DVD. (Modification Affects: Labeling).
• 3. Provided update 510(k) information (see table below). The following minor modifications were made to the predicate device and are considered update 510(k) information for this submission.

The syngo Application Software VD11 may be installed either on Siemens released PC hardware or on Siemens X-ray systems also known as Siemens Angiography Systems. The combination of "syngo Application Software" and the Siemens released PC Hardware will be marketed as components of the "syngo X Workplace".

This 510(k) submission (K153346) for the "syngo Application Software VD11" is a modification of a previously cleared device (syngo X Workplace, K143319). The submission states that the modifications do not alter its fundamental scientific technology. Therefore, the acceptance criteria and study detailed below are primarily based on the claim of substantial equivalence to the predicate device and verification/validation testing of the modifications rather than a de novo clinical effectiveness study of the AI components.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a modification of a predicate device with a focus on software updates and a renamed version, the "acceptance criteria" are predominantly related to the successful execution of non-clinical software verification and validation, and the continued conformance to recognized performance standards. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for an AI component are provided as acceptance criteria or reported device performance in this document. The document primarily focuses on ensuring the modified software functions as intended and safely as the predicate.

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

The document does not specify a "test set" in the context of a dataset for a clinical performance study of an AI algorithm. Instead, it refers to "non-clinical tests" and "verification and validation testing" during product development. This likely involves testing different functionalities of the software on various configurations and with different types of medical images, but the exact sample size of images or test cases is not quantified or detailed.

The provenance of data used for these non-clinical tests is not specified (e.g., country of origin, retrospective/prospective). The mention of "clinical images" being found acceptable (page 10) likely refers to images used in functional testing or from the predicate's clearance, rather than a new clinical study for this specific submission.

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. Given that the submission is for a software update and a claim of substantial equivalence, a new large-scale clinical study with expert-established ground truth for an AI component is not detailed. The "ground truth" for the non-clinical functional testing would be the expected output or behavior of the software based on its specifications, which would be established by internal engineering and quality assurance teams.

4. Adjudication Method for the Test Set

Not applicable, as a specific "test set" and ground truth establishment by experts in a clinical study sense are not 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 in this document. The device is described as "medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data... intended to assist the physician in diagnosis, treatment planning and treatment control." It facilitates existing diagnostic and interventional workflows but doesn't present itself as an AI-driven diagnostic aid that would typically warrant a comparative effectiveness study measure human reader improvement with/without AI.

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

This submission does not describe a standalone performance study for an AI algorithm. The device is a comprehensive application software that facilitates image viewing and post-processing, implying human interaction is integral to its intended use.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the software's functional verification and validation, the "ground truth" would be the expected behavior or output of the software as defined by its design specifications and requirements. For any image processing or measurement functions, the ground truth would likely be established through reference software, manual measurements, or phantoms, rather than clinical ground truth like pathology or outcomes data in this specific 510(k) for a software update. The document mentions "clinical images were found acceptable," suggesting that previously established reference imaging or ground truth might have been utilized for assessment, but not detailed as a new ground truth establishment process for this submission.

8. The Sample Size for the Training Set

Not applicable. This submission is for a software update (renamed version VD11 with minor modifications to the predicate VD10) and does not describe the development or training of a new AI algorithm. The core functionality and software packages (e.g., syngo Dyna3D, syngo Needle Guidance) are stated to be the "Same" as the predicate device.

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

Not applicable, as there is no description of a new AI algorithm being developed or trained as part of this specific 510(k) submission.

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