(91 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 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 include: minimally invasive surgical procedures and minimally invasive tumor treatment.
The "syngo Application Software" (VD20) 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 quided 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" (VD20) 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" (VD20) cleared in K163285 with the exception of the added new software feature "syngo TrueFusion".
The provided document describes the acceptance criteria and a study proving that the "syngo TrueFusion" software feature, added to the "syngo Application Software" (VD20), meets these criteria.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for "syngo TrueFusion"
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mean Deviation | Shall not exceed 3mm | Experiment 1: Position A: 2.92mm, Position B: 2.59mm, Position C: 2.31mm |
Experiment 2: Position A: 2.76mm, Position B: 2.57mm, Position C: 2.13mm |
| Standard Deviation (for Mean) | Shall not exceed 2mm | Experiment 1: Position A: 1.29mm, Position B: 1.50mm, Position C: 1.62mm
Experiment 2: Position A: 1.31mm, Position B: 1.69mm, Position C: 1.48mm |
| Clinical Acceptance | N/A (Implicit in achieving metrical criteria) | All results were clinically accepted by a board certified cardiologist. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 28 phantom test data sets.
- Data Provenance: The document does not specify the country of origin. It indicates the data was generated from "phantom test data sets," which are typically controlled, lab-based experiments. It is a retrospective analysis of this phantom data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One (1) board certified cardiologist.
- Qualifications of Experts: The document states "a board certified cardiologist" performed the measurements and clinically accepted the results.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). It states that the measurements were performed from different directions by "a board certified cardiologist" and "All results were clinically accepted by a board certified cardiologist." This suggests a single expert's assessment was used to clinically validate the numerical results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The study focuses on the technical performance of the "syngo TrueFusion" feature in a phantom setting (mean deviation and standard deviation) and its clinical acceptance by a single expert. It does not evaluate human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the performance metrics (mean deviation and standard deviation) appear to be a standalone evaluation of the algorithm's accuracy in co-registration on phantom data. While a cardiologist "performed multiple measurements" and "clinically accepted" the results, the core performance metrics are objective measurements of the algorithm's output against implied ground truth on the phantom. This is an evaluation of the software's inherent performance.
7. The Type of Ground Truth Used
- The ground truth was established by phantom measurements. The acceptance criteria are based on the deviation from some reference or true value on the phantom, and those measurements were clinically accepted by a board-certified cardiologist.
8. The Sample Size for the Training Set
- The document does not specify a sample size for a training set. The study pertains to the validation of a new software feature, "syngo TrueFusion," which includes "probe detection enhanced by machine learning" (Claim 8). However, it only details the test data used for validation (28 phantom test data sets) and does not provide information about the data used for training the machine learning component.
9. How the Ground Truth for the Training Set was Established
- Since the document does not specify a training set, it does not describe how ground truth for the training set was established.
§ 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).