(114 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, 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 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 turnor 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-quided solutions in the operating room, for imageguided 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 the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.
Siemens "syngo Application Software" (VD20B) 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" (VD20B) K170747 with exception of the added software options "Instant Fusion" and "Common Patient Registration". The new optional software features are only possible in an angiography (ARTIS Family) and CT (SOMATOM CT Sliding Gantry) systems configuration known as "nexaris Angio-CT".
"Instant Fusion" and "Common Patient Registration" is the subject of this submission. These features seamlessly integrate Angio and CT together and facilitate combined use. The "Instant Fusion" is an overlay of CT datasets to the Angiography image. The overlay is a position based registration of the CT gantry. The "Common Patient Registration" is the patient data transfer from "syngo Application Software" to the CT system using a communication interface.
This document is a 510(k) summary for the syngo Application Software (VD20B) by Siemens Medical Solutions USA, Inc. The submission requests clearance for two new optional software features: "Instant Fusion" and "Common Patient Registration." The study presented is a non-clinical performance test comparing the subject device (VD20B) with its predicate device (VD20A, K170747).
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the acceptance criteria in terms of successful verification and validation testing, confirming that the new features ("Instant Fusion" and "Common Patient Registration") function as intended and do not raise new issues of safety or effectiveness. The reported device performance indicates these criteria were met.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | - "Instant Fusion" successfully overlays CT images without additional 2D/3D registration. |
- "Common Patient Registration" successfully transfers patient data automatically from the Angiography system to the syngo Application Software and the CT system. | - "Instant Fusion": "Measurements were performed with CT images to the interface simulator. The tests showed that CT images can be directly overlaid without additional 2D/3D registration."
- "Patient Registration": "Measurements were performed with different patient images to the interface simulator. The tests showed that the Patient data is automatically transferred after Patient registration on the Angiography system." |
| Safety and Effectiveness | - No new issues of safety or effectiveness are raised compared to the predicate device. - Conformance to relevant medical device standards (e.g., ISO 14971, IEC 60601-1-6, IEC 62304, IEC 62366-1, IEC 80001-1). | - "Results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness."
- "All software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device that is currently marketed for the same intended use."
- Conformance claims made for the listed standards in section 8. |
| Risk Management | Risks identified and mitigated; testing results support meeting acceptance criteria. | "The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria." |
| Human Factors/Usability | No safety-relevant functions requiring summative usability validation. | "The Human Factor Usability Validation showed no safety-relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines." |
| Cybersecurity | Compliance with cybersecurity requirements, including prevention of unauthorized access/misuse. | "Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access… Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set of "Instant Fusion" or "Common Patient Registration." It refers to "measurements were performed with CT images" and "measurements were performed with different patient images," implying a set of images/data was used, but the quantity is not specified.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is a country of origin provided for the data used in validation testing. However, given it's a non-clinical performance test for software features, the data would likely be generated in a controlled environment as part of product development and verification.
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 to establish ground truth for the software's functional validation. The testing described appears to be technical verification against predefined software specifications and functional requirements rather than a clinical evaluation requiring expert consensus on diagnostic accuracy.
4. Adjudication Method for the Test Set
Since the validation involved technical performance testing of software features (overlay and data transfer), rather than a diagnostic accuracy study with ambiguous cases, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned. The "ground truth" here is the system's intended technical function as defined by its specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or reported. The submission focuses on the technical functionality and safety/effectiveness equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described ("Instant Fusion" overlay and "Patient Registration" data transfer) represents a standalone algorithm performance evaluation in terms of its technical functionality. The tests assessed whether the software features performed their designated tasks (image overlay, data transfer) correctly as programmed, independent of human interpretation or interaction during the measurement itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the testing of "Instant Fusion" and "Common Patient Registration" appears to be the software's predefined functional specifications and technical requirements. For "Instant Fusion," the ground truth is the successful direct overlay of CT images via position-based registration. For "Patient Registration," the ground truth is the automatic and correct transfer of patient data.
8. The Sample Size for the Training Set
The document is a 510(k) summary for software features within an existing "syngo Application Software." It does not mention any training set size, which suggests that these features are likely rule-based or deterministic algorithms (for image overlay and data transfer) rather than machine learning or AI models that would require a distinct training phase with a labeled dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied for these specific software features (as they appear to be deterministic functions), the concept of establishing ground truth for a training set is not applicable here.
§ 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).