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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 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.

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