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510(k) Data Aggregation
(169 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 of the Siemens 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 diaming and 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" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time 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" (VE2) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems.
Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission.
The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. The "syngo Application Software" (VE2) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remains the same.
The document describes the Siemens "syngo Application Software" (VE2) and its new optional software features: syngo DynaCT Sine Spin, syngo DynaCT Multiphase, and syngo Embolization Guidance. The submission aims to demonstrate substantial equivalence to the predicate device, "syngo Application Software" (VD20) (K173611).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a specific table with distinct "acceptance criteria" against which quantitative "reported device performance" is measured in a typical clinical trial format (e.g., Sensitivity X, Specificity Y). Instead, the acceptance is based on demonstrating that the new features are as safe and effective as the predicate device. The performance is reported through the results of bench testing and software validation, confirming the functionality and safety of the new features.
The core acceptance criterion is implicit: The new features ("syngo DynaCT Sine Spin", "syngo DynaCT Multiphase", and "syngo Embolization Guidance") must perform as intended, produce equivalent or improved image quality/functionality compared to the predicate, and not introduce any new issues of safety or effectiveness.
| Feature Tested | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| syngo DynaCT Sine Spin | Must provide better data coverage resulting in less cone beam artifacts compared to the predicate's syngo DynaCT, while maintaining the same reconstruction method and not introducing new safety/effectiveness issues. | "Bench test were conducted and 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." Specific tests included: Homogeneity of reconstructed image, Spatial Resolution, Contrast to Noise Ratio, Geometric Distortion, Radiation Metrics CTDI, DAP, Artifact analysis, Gantry positioning accuracy, z-direction Resolution (Reconstructed section thickness). |
| syngo DynaCT Multiphase | Must successfully depict 10 different time points within 60 seconds (compared to a single spin or four for cardiac imaging in the predicate), maintain the same reconstruction method, and not cause a reduction in image quality, nor introduce new safety/effectiveness issues. | "Bench test were conducted and 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." A phantom study was performed "to exclude a potential reduction in image quality over 10 runs." Specific tests included: Homogeneity of reconstructed image, Spatial Resolution, Contrast to Noise Ratio, Geometric Distortion, Radiation Metrics CTDI, DAP, Artifact analysis, Gantry positioning accuracy, z-direction Resolution (Reconstructed section thickness). |
| syngo Embolization Guidance | The modified feature, allowing user-defined proximal points, must increase applicability while the calculation method and algorithm remain unchanged and perform effectively in feeder vessel detection. It should not introduce new safety/effectiveness issues. | "Bench test were conducted and 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." The feeder detection algorithm was "validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries." |
| Overall Software Quality | Conformance to standards (ISO 14971, IEC 82304-1, IEC 62304, IEC 62366-1, IEC 80001-1), appropriate software verification and validation for a Moderate Level of Concern, successful risk analysis and mitigation, validated usability, and cybersecurity measures. | "All testable requirements... have been successfully verified and traced... The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans." "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." "The Human Factor Usability Validation showed no safety relevant functions that need to be validated with a summative usability validation." "Siemens conforms to the cybersecurity requirements." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The primary testing presented involves bench testing and phantom studies. For the "syngo Embolization Guidance" a "study of randomly selected clinical cases" was performed, but the sample size is not specified. The document does not provide details on data provenance (country of origin) or whether the clinical cases were retrospective or prospective. It appears that the clinical case study for Embolization Guidance was not the primary means of validation for this 510(k), as it focuses on demonstrating safety and effectiveness mainly through non-clinical methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for any part of the test set. For the "syngo Embolization Guidance" clinical case study, it states the algorithm was "validated," implying comparison to some form of truth, but details are absent. For bench and phantom tests, ground truth would naturally be established by the physical properties of the phantoms/test setups.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set. Given the nature of the validation (bench testing, phantom studies, and an unspecified clinical case study), a formal multi-reader adjudication process for establishing ground truth is not explicitly mentioned or implied.
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 MRMC comparative effectiveness study is described in the provided text. The submission focuses on demonstrating substantial equivalence of the software features themselves, not on the improvement of human reader performance with AI assistance. The device is a "Picture Archiving and Communications System" with features to assist physicians in image viewing and post-processing, not an AI diagnostic aid that directly impacts human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing primarily focuses on the standalone performance of the algorithms and software features themselves through bench tests and phantom studies. For example, the image quality metrics (homogeneity, spatial resolution, CNR, etc.) are objective measures of the algorithm's output. The validation of the "syngo Embolization Guidance" feeder detection algorithm is also an assessment of its standalone accuracy, even if comparing against clinical cases.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For syngo DynaCT Sine Spin and syngo DynaCT Multiphase: Ground truth for image quality and physical properties (e.g., homogeneity, spatial resolution, CNR, geometric distortion, z-direction resolution) would be established by the known physical properties of the phantoms and the design specifications of the system.
- For syngo Embolization Guidance: The feeder detection algorithm was "validated in a study of randomly selected clinical cases." This implies comparison to clinical ground truth, which for feeder vessels is typically established through expert review of angiographic images or potentially confirmed by intervention outcomes, though the document does not specify the exact nature of this clinical ground truth.
8. The sample size for the training set
The document does not mention a training set size. This might be because the changes are primarily functional enhancements to existing software features rather than completely new AI algorithms that require extensive training data. It states the "algorithm was not changed" for syngo Embolization Guidance, implying it was pre-existing.
9. How the ground truth for the training set was established
Since no training set is explicitly mentioned or described, the method for establishing its ground truth is not provided.
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