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syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

lt provides tools to view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

• Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
• Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• Automated Contouring on CT images
• Creation of contours on images supported by the application without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and deformable registration
• Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
• Supports multi-modality image fusion
• Visualization and contouring of moving tumors and organs
• Management of points of interest including but not limited to the isocenter
• Creation of simple geometric treatment plans
• Generation of a synthetic CT based on multiple pre-define MR acquisitions

The subject device with the current software version SOMARIS/8 VB80 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. The current software version SOMARIS/8 VB80 are as follows:

• Modifications in Advanced Contouring: Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc. Both native and contrasted CT images are included.
• Revised User Interface

The provided text describes the regulatory clearance of "syngo.via RT Image Suite" and includes information about its performance evaluation. The focus of the performance data section is on the AI-based autocontouring feature.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the AI-based autocontouring feature were defined based on the Dice coefficient, a commonly used overlap metric. The text states:

"All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature."

While the specific numerical threshold for the Dice coefficient acceptance criterion is not explicitly stated in the provided document, the statement confirms that the results met the pre-defined criteria.

Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 413 subjects
• Data Provenance: The test data was generated from an independent set not seen during training. It covers a wide range of CT scanners and acquisition parameters.
  • Geographic Origin: Europe (IT, PT, CH, UK, NL, DE), North America (US, CA), South America (BR), Australia, Asia (JP, IN).
  • Retrospective/Prospective: Not explicitly stated, but "obtained through clinical collaborations" suggests retrospective collection of existing clinical data.

Breakdown of Test Set Distribution (from Table 1):

• Data Source: Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33, unknown: 12
• Body Region: Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84
• Gender: Male: 188, female: 174, Unknown: 51
• Age: 70: 20, unknown: 340
• Slice thickness (in mm): 3: 19
• Manufacturer (Scanner): Siemens: 126, GE: 77, Philips: 140, unknown/others: 70

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

• Number of Experts: An "expert team" was used, but the specific number is not provided.
• Qualifications: "based on well accepted international contouring guidelines". The specific qualifications of the experts (e.g., radiologist with X years of experience) are not detailed.

4. Adjudication Method for the Test Set:

• The ground truth was established by an "expert team" and then followed by a "rigorous independent quality assessment." This suggests a form of review or adjudication, but the exact method (e.g., 2+1, 3+1) is not specified.

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

• No. The provided text describes a standalone performance evaluation of the AI algorithm (autocontouring feature) against a manually annotated ground truth. It does not mention a comparative study involving human readers with and without AI assistance to measure improvement in human performance.

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

• Yes. The performance evaluation described is purely a standalone assessment of the AI-based autocontouring feature. It compares the algorithm's output directly to the "manually annotated ground truth" using the Dice coefficient.

7. The Type of Ground Truth Used:

• Expert Consensus/Manual Annotation: "Manual ground-truth segmentations were annotated by an expert team based on well accepted international contouring guidelines, followed by a rigorous independent quality assessment."

8. The Sample Size for the Training Set:

• The document states that the validation data (test set) was "20% of the available data." This implies the training set was the remaining 80% of the total available data. However, the total available data size for both training and validation is not explicitly stated. Thus, the specific numerical sample size for the training set cannot be determined from this text.

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

• While not explicitly detailed for the training set, the text mentions that "Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc."
• Given the method for the test set ("Manual ground-truth segmentations were annotated by an expert team"), it is highly probable that the ground truth for the training set was established through a similar process of expert manual annotation, though this is not explicitly confirmed for the training data in this section.

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syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

• . Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
• Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• . Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• Automated Contouring on CT images
• . Creation of contours on images supported by the application without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and deformable registration ●
• . Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
• . Supports multi-modality image fusion
• . Visualization and contouring of moving tumors and organs
• Management of points of interest including but not limited to the isocenter ●
• . Creation of simple geometric treatment plans
• Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The subject device with the current software version SOMARIS/8 VB70 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

For the current software version SOMARIS/8 VB70 the following already cleared features have been modified:

• Patient Marking
• Contouring
• 4D Features ●
• Basic Features of the subject device ●

The provided text describes the acceptance criteria and a study demonstrating that the lobe-based lung ventilation algorithm within the syngo.via RT Image Suite meets these criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines the following digital image processing and visualization tools:

• . Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
• Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume ● rendering technique (VRT)
• . Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• Automated Contouring on CT images
• . Creation of contours on images supported by the application without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and deformable registration
• Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
• . Supports multi-modality image fusion
• . Visualization and contouring of moving tumors and organs
• Management of points of interest including but not limited to the isocenter ●
• Creation of simple geometric treatment plans ●
• Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The subject device with the current software version SOMARIS/8 VB60 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:

• . Reference Point Management
• Patient Marking ●
• Contouring / Routine Contouring
• Structure Set Management ●
• Synthetic CT
• Basic Feature of syngo,via RT Image Suite

The provided documentation relates to the Siemens syngo.via RT Image Suite, specifically describing its 510(k) premarket notification for a new software version (SOMARIS/8 VB60) that includes an AI-based algorithm for synthetic CT generation.

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

Acceptance Criteria and Reported Device Performance

The document describes performance criteria for the AI-based algorithm for generating synthetic CT images from MR images. While not presented in a formal table with specific thresholds, the text outlines the key metrics evaluated and the results.

The document states that the geometric deviation of `

Ask a specific question about this device

syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The subject device with the current software version SOMARIS/8 VB50 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

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

Note: The provided text is a 510(k) summary for an existing device's software update, not a full clinical study report. Therefore, some details typically found in a full study report (like the exact geographic origin of all data, detailed expert qualifications and adjudication methods for ground truth, or full power analysis for sample sizes) are not explicitly stated. The information below is extracted and inferred from the available document.

Acceptance Criteria and Device Performance Study for syngo.via RT Image Suite (SOMARIS/8 VB50) automated organ segmentation algorithm

The focus of the performance evaluation in this 510(k) application is on the updated automated organ segmentation algorithm in the syngo.via RT Image Suite (SOMARIS/8 VB50), specifically its extension to additional organs compared to the predicate device (SOMARIS/8 VB40). The core algorithm is stated to be the same.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 112 subjects.
• Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "performance evaluation" of the algorithm, comparing it to a predicate device. It does not explicitly state if it was retrospective or prospective, but performance evaluations of algorithms on a test set often utilize retrospectively collected data.

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

• Number of Experts: Not specified. The document mentions "manually annotated ground truth" but does not detail the number of annotators.
• Qualifications of Experts: Not specified. It's common in this domain for medical professionals (e.g., radiation oncologists, radiologists, medical physicists) to perform such annotations, but their specific qualifications or years of experience are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Since the ground truth is referred to as "manually annotated," it's possible a single expert annotated or multiple experts annotated with or without an arbitration/adjudication process. The document does not provide these details.

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

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The evaluation focuses on the standalone performance of the automated segmentation algorithm compared to a "manually annotated ground truth" and compared to the predicate device's algorithm.

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

• Standalone Performance: Yes, a standalone (algorithm-only) performance evaluation of the automated organ segmentation algorithm was performed. The evaluation involved comparing the algorithm's output directly against a manually annotated ground truth using the DICE coefficient and assessing detection rates.

7. The Type of Ground Truth Used

• Type of Ground Truth: "Manually annotated ground truth." This typically implies expert consensus or single expert annotation, but the precise method and number of experts are not detailed. It is explicitly contrasted with the "algorithm result," confirming it's an expert-derived truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document states that "The AI or deep learning-based algorithm has been initially cleared with the predicate device RT Image Suite SOMARIS/8 VB40 (K192065)," and "The fundamental algorithm did not change." This suggests the training was done for the predicate device's initial clearance, and this submission focuses on the extension of its application to more organs using the same fundamental algorithm. The size of the original training set is not provided in this document.

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

• Training Set Ground Truth Establishment: Not explicitly detailed in this document. Given that the fundamental algorithm was used in the predicate device, it can be inferred that the training data and corresponding ground truth were established historically for the original algorithm development. It is common for ground truth for deep learning training in medical imaging to be established through expert annotations, potentially with internal review or consensus processes, but specific details are not provided here.

Ask a specific question about this device

syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines following digital image processing and visualization tools:

• Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
• Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• Creation of contours on any type of images without prior assignment of a planning CT .
• Manual and semi-automatic registration using rigid and deformable registration ●
• Supports the user in comparing, contouring, and adapting contours based on datasets acquired ● with different imaging modalities and at different time points
• . Supports the user in comparing images and contours of different patients
• Supports multi-modality image fusion ●
• Visualization and contouring of moving tumors and organs ●
• Management of points of interest including but not limited to the isocenter
• Management of simple treatment plans
• Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The subject device with the current software version SOMARIS/8 VB40 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

Here's a breakdown of the acceptance criteria and study details for the syngo.via RT Image Suite, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the subject device "improved for all evaluated OAR" for both ASSD and DICE coefficient compared to the predicate device, but does not provide the specific predicate device values for direct comparison in this summary.

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

• Test Set Sample Size: 32 datasets
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not explicitly stated in the provided text.
• Qualifications of Experts: The ground truth was "manually annotated." While this implies expert review, the specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document mentions "manually annotated ground truth," but does not specify if multiple annotators were used and how discrepancies were resolved (e.g., 2+1, 3+1).

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

• MRMC Study: No. The study described is a comparison of the subject device (algorithm) performance against manually annotated ground truth, and an improvement over a predicate device's algorithm. It does not assess human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Yes. The clinical testing summary describes the performance of the algorithm itself, specifically focusing on "detection rate" and "segmentation quality" based on metrics like ASSD and DICE coefficient. It compares the subject device's algorithm (SOMARIS/8 VB40) to the predicate device's algorithm (SOMARIS/8 VB30).

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (specifically, "manually annotated ground truth").

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document mentions a "new deep learning-based approach that uses an adversarial network" and that its "segmentation algorithm were validated separately using a testing set of 32 datasets," but does not provide details on the training set size.

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

• Training Set Ground Truth Establishment: Not explicitly stated. While the test set ground truth was "manually annotated," the method for establishing the training set ground truth, especially for a deep learning model, is not described in this summary.

Ask a specific question about this device

syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.

The software combines following digital image processing and visualization tools:

· Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI. Linac Cone Beam CT (CBCT) images and dose distributions

· Multiplanar reconstruction (MPR) think minimum intensity projection (MIP), volume rendering technique (VRT)

• · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• · Creation of contours on any type of images without prior assignment of a planning CT

· Manual and semi-automatic registration using rigid and deformable registration

· Supports the user in comparing, and adapting contours based on datasets acquired with different imaging modalities and at different time points

· Supports the user in comparing images and contours of different patients

• · Supports multi-modality image fusion
• · Visualization and contouring of moving tumors and organs
• · Management of points of interest including but not limited to the isocenter
• · Management of simple treatment plans
• · Generation of a synthetic CT based on multiple pre-define MR acquisitions

syngo.via RT Image Suite is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. The subject device syngo.via RT Image Suite with software version SOMARIS/8 VB30 is a further extension of the previously cleared primary predicate device syngo.via RT Image Suite with software version SOMARIS/8 VB20 and supports the following modifications:

• 1. Modified Indications for Use Statement
• 2. Support of software version SOMARIS/8 VB30 which supports the following functionality:
  • a. Support of Beam Placement
    • Support of Synthetic CT b.
    • Support of modified contouring tools c.
      • i. Routine Contouring
      • ii. Advanced Contouring
      • iii. Rapid Results Technology
    • d. Support of modified structure management

syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

The provided text is a 510(k) summary for the syngo.via RT Image Suite, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance metrics and acceptance criteria for a new device.

Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, a standalone study, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC study results, or detailed ground truth establishment for a clinical performance evaluation of the device as if it were a new AI/CADx system.

The document details non-clinical testing and verification/validation activities to ensure the software functions as intended and meets safety and performance standards. It also mentions "supportive articles" for specific device functionality, including the "Synthetic CT feature," which "demonstrates the classification of tissues for brain acquisitions method used for the synthetic CT feature included in this submission." However, these are not presented as a standalone clinical study with the requested metrics.

Thus, I cannot populate the table or answer the specific questions directly from the provided text as it does not contain that information.

Ask a specific question about this device

syngo via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).

It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System.

The software combines following digital image processing and visualization tools:

• Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
• · Multiplanar reconstruction (MPR) thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• · Creation of contours on any type of images without prior assignment of a planning CT
• Manual and semi-automatic registration using rigid and deformable registration
• · Supports the user in comparing, and adapting contours based on datasets acquired with different imaging modalities and at different time points
• · Supports the user in comparing images and contours of different patients
• Supports multi-modality image fusion
• · Visualization and contouring of moving tumors and organs
• · Management of points of interest including but not limited to the isocenter

syngo.via RT Image Suite is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy.

syngo.via RT Image Suite combine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.

The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.

The following features have been modified:

• Routine Annotation Functionality (modified) ●
• Contouring Tools (modified)
• Patient Marking (modified)
• . Structure Set Management (modified)
• Alignment Tools (modified)
• Dose Evaluation (new)

The provided text describes the "syngo.via RT Image Suite" and its 510(k) submission, comparing it to predicate devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing (integration and functional tests, software verification and validation, risk analysis) and adherence to recognized standards. It does not present a detailed study with specific acceptance criteria and reported device performance metrics in the format requested, especially regarding clinical metrics, sample sizes for test sets, ground truth establishment, or comparative effectiveness studies with human readers.

The document states that "The testing results support that all the software specifications have met the acceptance criteria," but it does not specify what those acceptance criteria were or present the reported device performance against those criteria in a quantitative manner.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications where information is missing:

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

The document states, "The testing results support that all the software specifications have met the acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the quantitative reported device performance for the syngo.via RT Image Suite. The "Performance Data" section primarily describes the types of tests conducted (non-clinical integration and functional tests, software verification/validation, risk analysis) and a general conclusion that the device performs as intended and meets acceptance criteria.

2. Sample sizes 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 in the document. The text mentions "non clinical tests (integration and functional)" and "verification/validation testing" but does not specify the sample size of cases, images, or data used for these tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective). Given the non-clinical nature of the described tests, clinical "test sets" in the sense of patient data with ground truth might not have been the primary focus of the performance data presented here.

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 in the document. As the described performance data is related to non-clinical software testing, there is no mention of experts establishing ground truth for a clinical test set.

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

This information is not provided in the document. No adjudication method is mentioned, likely because the performance data section focuses on software verification and validation rather than a clinical study requiring adjudicated ground truth.

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

The document does not indicate that an MRMC comparative effectiveness study was performed or that human readers' performance with/without AI assistance was evaluated. The device is described as an "image visualization, multimodality manipulation and contouring tool" that helps preparation and response assessment, implying it supports human users, but no study on human performance improvement is detailed.

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

The document does not explicitly present data from a "standalone" algorithm performance study in a clinical context. The performance data focuses on "non clinical tests (integration and functional)" along with "software verification and validation," which are evaluations of the software's functionality and adherence to specifications, not necessarily its autonomous clinical performance as an "algorithm only" device.

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

The document does not specify the type of ground truth used for any particular test set. Given the described non-clinical nature of the tests, ground truth likely refers to expected software behavior or outputs according to specifications rather than clinical benchmarks like pathology or expert consensus on medical images.

8. The sample size for the training set

This information is not provided in the document. The text does not refer to a "training set," which would typically be relevant for machine learning or AI-based devices. While the device has "semi-automatic contouring" and "manual and semi-automatic registration," the document describes these as features without detailing any machine learning training processes or associated datasets.

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

This information is not provided in the document, as no training set is mentioned in the context of performance data.

Summary of what can be inferred or is explicitly stated regarding the "study":

• Type of Study: Non-clinical (integration and functional tests, software verification and validation).
• Purpose: To demonstrate conformance with special controls for medical devices containing software, mitigate identified hazards (risk analysis), and support the claim of substantial equivalence to predicate devices.
• Acceptance Criteria (General): "all the software specifications have met the acceptance criteria." (Specific criteria not detailed).
• Reported Device Performance (General): The device "performs as intended" and "performance is comparable to the predicate devices." (Specific quantitative performance metrics not detailed).
• Standards Conformed To: DICOM Set (PS 3.1 - 3.20), IEC 62304 (Medical device software - Software life cycle processes), ISO 14971 (Application of risk management to medical devices), IEC 60601-1-6 (Usability), IEC 60601-1-4 (Programmable electrical medical systems).
• Support for Claims: Six scientific articles are mentioned as used to support marketing claims in the product brochure, but these are not described as part of the core performance data reported for this 510(k) submission.

In conclusion, the document focuses on regulatory compliance through non-clinical software testing and comparison to predicates, rather than providing a detailed clinical study with the specific criteria and performance metrics requested.

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syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools:

• · Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images
• · Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
• · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
• · Creation of contours on any type of images without prior assignment of a planning CT
• · Manual and semi-automatic registration using rigid and deformable registration
• · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points. Supports the user in comparing images and contours of different patients
• · Supports multi-modality image fusion
• · Visualization and contouring of moving tumors and organs

syngo.via RT Image Suite is an image analysis software used for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-atrisk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. The synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support.

Here's a summary of the acceptance criteria and study information for the syngo.via RT Image Suite, based on the provided document.

Important Note: The provided FDA 510(k) summary is a high-level overview. It describes the general V&V processes and states that acceptance criteria were met, but it does not provide specific acceptance criteria values or detailed performance metrics reported for the device. It primarily focuses on demonstrating substantial equivalence to predicate devices and meeting software safety standards.

Acceptance Criteria and Reported Device Performance

• Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 - 3.18)
• Medical device software - Software life cycle processes (IEC 62304 First edition 2006-05)
• Medical devices - Application of risk management to medical devices (ISO 14971 Second Edition 2007-03-01)
• Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability (IEC 60601-1-6 Edition 3.0 2010-01)
• Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:2000, Consol. Ed. 1.1) |

Study Details

1. Sample size used for the test set and the data provenance:
   The document states that "Integration and functional tests were conducted for syngo.via RT Image Suite during product development," and "Performance tests were conducted to test the functionality of the subject device." However, no specific sample sizes (e.g., number of cases, images) for the test set are provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not specified in the provided document. The document describes the device as a "contouring tool" and mentions "software assisted contouring," implying human input. However, it does not detail how specific ground truth for quantitative evaluation would have been established or by whom.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not specified. The document focuses on verification and validation against software specifications and industry standards rather than a formal human-in-the-loop clinical adjudication study.

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 is mentioned. The device is described as a "visualization, manipulation and contouring tool" that "helps the preparation and response assessment," and "supports the medical professional with tools." This indicates it's an assistive technology, but a formal study measuring the improvement of human readers with vs. without AI assistance is not detailed. The primary goal of this 510(k) submission is substantial equivalence to predicate devices.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document focuses on the software as a device, and its functions are described as assisting the human professional. While the software has semi-automatic features (e.g., semi-automatic contouring, deformable registration), the submission does not present "standalone" performance metrics (e.g., sensitivity/specificity for a diagnostic task purely performed by the algorithm). Its role is described as a tool for "viewing, manipulation, ... and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning," suggesting it's designed to be used with human oversight and interaction.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As details about specific performance evaluation studies are absent, the type of ground truth used is not explicitly stated. Given the device's function (contouring, image manipulation), it's highly probable that ground truth would involve expert-derived manual contours or measurements against which the software's outputs (e.g., semi-automatic contours, registration accuracy) would be compared. However, this is inferential.

7. The sample size for the training set:
   Not specified. The document mentions software modifications like "Advanced Contouring" (freehand editing, 3D Nudge tools) and "Deformable Alignment" which might involve machine learning components requiring training data. However, details about training sets (size, composition, ground truth generation) are not included in this 510(k) summary.

8. How the ground truth for the training set was established:
   Not specified. As the existence and details of a training set are not mentioned, the method for establishing its ground truth is also not provided.

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