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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, 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."

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

• Test Set Sample Size: 22 DynaCT test data sets.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's described as "DynaCT test data sets," which are images acquired from Siemens Angiography systems. The document doesn't specify if they are retrospective or prospective. Given they are "test data sets" used for evaluation of an existing algorithm, they are highly likely retrospective.

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

• Number of Experts: "a board certified radiologist" (singular)
• Qualifications: "board certified radiologist"

4. Adjudication Method for the Test Set

• Not explicitly stated, but since only one expert is mentioned as having "clinically accepted" the results, it implies no formal multi-reader adjudication process (e.g., 2+1 or 3+1). The "clinical acceptance" by a single radiologist serves as the informal "ground truth establishment" for the performance evaluation cited.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a MRMC comparative effectiveness study was not done or at least not described in this document. The provided performance data relates to the algorithm's performance and its manual correction rate, not a comparison of human reader performance with and without AI assistance.

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

• Yes, partially. The "automatic detection rate is 73%" can be considered a standalone performance metric for the algorithm without human intervention. The "detection rate for an automatic detection including manual correction is 86%" represents a human-in-the-loop scenario, where the human corrects the algorithm's output.

7. The Type of Ground Truth Used

• Expert Consensus / Clinical Acceptance: The ground truth was established by a "board certified radiologist" who "clinically accepted" the results. This suggests expert review and judgment rather than pathology or long-term outcomes data serving as a definitive ground truth.

8. The Sample Size for the Training Set

• Not specified in this document. The document focuses on the validation or test set performance (22 DynaCT test data sets) for this specific feature. Information about the training set size or composition is typically found in design control documents, which are not part of this 510(k) summary.

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

• Not specified in this document. As with the training set size, the method for establishing ground truth for training data is not detailed in this submission.

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