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syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.

The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).

syngo. CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.

syngo.CT CaScoring is a post processing application designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.

A listing of device modifications as part of the new software version SOMARIS/8 VB40 of syngo.CT CaScoring is as follows:

• Updated Indications for Use Statement .
• Support of the CaScoring algorithm to precompute the calcium score ●
• Support of Rapid Results Technology for the CaScoring algorithm ●

The Siemens syngo.CT CaScoring device is an image analysis software package for evaluating CT data sets to identify and quantify calcified coronary lesions.

Here's an breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the acceptance criteria for the automated calcium scoring evaluation involved demonstrating "adequate overall accuracy of the prediction of the calcium risk category." However, specific numerical thresholds for "adequate accuracy" are not explicitly stated in the provided text. The reported performance is that the algorithm was "successfully executed on all test data" and an "adequate overall accuracy" was found.

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

The document mentions that the automated calcium scoring evaluation was validated using a "bench test" and that the algorithm was implemented on "all test data." While it states that the algorithm was "successfully executed on all test data," it does not specify the sample size of the test set nor its data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to any effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the automated calcium scoring evaluation. The document states: "For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found." This indicates that the algorithm's performance was evaluated by itself.

7. Type of Ground Truth Used

The document implies that the ground truth for the automated calcium scoring evaluation test set was based on a "prediction of the calcium risk category." However, the method by which this ground truth was established (e.g., expert consensus, pathology, outcomes data) is not explicitly stated. Given that the device interactively marks calcified lesions and calculates scores, it is likely based on expert annotations or a reference standard derived from medical imaging.

8. Sample Size for the Training Set

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

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.

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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 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.

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