(65 days)
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.
| Feature Update | Acceptance Criteria | Reported Device Performance and Comparison |
|---|---|---|
| syngo EVAR Guidance | Updated automated feature does not raise any new issues of safety or effectiveness. | No new issues of safety or effectiveness. System Software Validation and testing was conducted. |
| syngo CTO Guidance | Updated automated feature does not raise any new issues of safety or effectiveness. | No new issues of safety or effectiveness. Validation and testing was conducted. |
| Automatic model-based LA segmentation | Updated automated feature does not raise any new issues of safety or effectiveness. | No new issues of safety or effectiveness. Validation and testing was conducted. |
| Improvements of DynaCT image quality | Improved image quality does not raise any new issues of safety or effectiveness. | No new issues of safety or effectiveness. Validation and testing was conducted. |
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).