(133 days)
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3Dvisualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and postprocessing 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 of the Siemens Healthineers 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 planning and treatment control. It includes commercially available postprocessing 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, communication, reporting, and storage of medical images and data on exchange media. It provides imageguided solutions in the operating room, for image-quided 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" is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.
The provided document describes a 510(k) submission for the "syngo Application Software," which is a modification (VE40C) of a previously cleared device (VE30A). The submission focuses on demonstrating substantial equivalence to the predicate device through non-clinical performance testing and software verification and validation.
However, the document does not contain the detailed breakdown of acceptance criteria and reported device performance in the format requested. Specifically, there is no table presenting quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported performance metrics. The document states that "All test results met all acceptance criteria" and "All conducted test results passed," but it does not specify what those criteria were.
Furthermore, information regarding sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance details, type of ground truth used, training set sample size, and ground truth establishment for the training set is not present in the provided text. The submission focuses on software changes and their verification, rather than clinical performance studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred, and what is missing:
Acceptance Criteria and Study Details (Based on available information):
| Information Point | Details from Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | Not provided in a quantitative table format. The document states broadly: |
- "All test results met all acceptance criteria."
- "All software validation data demonstrates that the Subject device is as safe and effective when compared to the Predicate Device... All test results met all acceptance criteria."
- "The testing results support that all the software specifications have met the acceptance criteria."
- "The results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness."
- "In summary, All conducted test results passed."
This indicates that internal functional and technical acceptance criteria were met for the software updates, but specific performance metrics for diagnostic accuracy or clinical effectiveness are not detailed. |
| 2. Sample size for the test set and data provenance | Not specified. The document mentions "Bench Test Summaries" for the updated syngo Biplane 3D Roadmap feature, and verification/validation testing for software functionalities, but does not provide details on data sources (e.g., number of cases/images) or provenance (country of origin, retrospective/prospective). |
| 3. Number of experts used to establish ground truth and their qualifications | Not applicable/Not specified. The testing described is primarily software verification and validation, and non-clinical performance (bench testing) related to the functional changes, rather than clinical accuracy requiring expert ground truth. |
| 4. Adjudication method for the test set | Not applicable/Not specified. As the testing is not described as involving diagnostic interpretation leading to a "truth" panel, adjudication methods are not mentioned. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. The document does not describe an MRMC study or any comparison of human reader performance with and without AI assistance. The device is software for image management, processing, and guidance; it's not described as an AI-powered diagnostic aid that would typically undergo such a study. |
| 6. Standalone (algorithm only without human-in-the-loop performance) study | Partially applicable, but for functional/technical performance, not diagnostic accuracy. The "Nonclinical Performance Testing" and "Software Verification and Validation" sections describe tests conducted on the software itself to ensure its functionalities (like myNeedle Guide steps, Biplane 3D Roadmap features) perform as intended. These are standalone tests in the sense that they evaluate the software's technical operation. However, the document does not present "standalone" performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) as would be relevant for an AI diagnostic device. The evaluation is against software specifications and safety/effectiveness relative to the predicate. |
| 7. Type of ground truth used | Not applicable/Not explicitly stated for clinical ground truth. The testing appears to be based on software specifications and functional correctness rather than clinical ground truth (e.g., pathology, outcomes data). For instance, for "Updated myNeedle Guide testing," the "ground truth" would be whether the software correctly executes the described steps (Biplane-Couple-A-B, Invoke Progress Needle Step, etc.) according to technical requirements. |
| 8. Sample size for the training set | Not specified. The document does not mention any training sets, suggesting the changes are primarily functional updates to existing software rather than the introduction of new machine learning algorithms requiring explicit training data. |
| 9. How the ground truth for the training set was established | Not applicable. No training set is mentioned. |
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is primarily a non-clinical performance testing and software verification and validation process for software updates to the existing "syngo Application Software." The focus is on demonstrating that the modified software (VE40C) maintains the safety and effectiveness of the predicate device (VE30A) and that the new functionalities operate correctly according to their technical specifications.
The testing involved:
- Software Verification and Validation: Adhering to FDA's "Guidance for the Content of Premarket Submissions for Device Software Functions" (Basic Level of Concern) and "Off-The-Shelf Software Use in Medical Devices." This includes risk analysis and control implementation.
- Bench Testing Summaries: Conducted for the specific new features.
- Updated myNeedle Guide testing: Encompassed scenarios like Biplane-Couple-A-B, Invoke Progress Needle Step messages, and switch-off drive functionalities.
- Updated syngo Biplane 3D Roadmap testing: Encompassed features like overlaying internal datasets, overlaying contours, alternative flow, 2D/2D 3D Registration OV Basic Flow Overlay Assist, Set Active Plane, and Biplane Registration Modes Segment Selection.
- Human Factor Usability Validation: Showed no safety-relevant functions requiring summative validation.
- Cybersecurity Compliance: Conformance to IEC 80001-1:2010.
The document asserts that "All test results met all acceptance criteria" and "All conducted test results passed," and that the software validation data demonstrates the subject device is as safe and effective as the predicate. The "acceptance criteria" appear to be internal software specifications and functional requirements validated through these non-clinical tests. This type of submission is common for software updates that do not introduce novel clinical functionalities but rather refine or add features to existing cleared software.
§ 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).