(105 days)
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, 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 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 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 VD11 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 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 VD11 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 evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.
Siemens syngo Application Software VD11 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 X Workplace (K143319).
The Subject Device is a modified version of the previously cleared syngo X Workplace software version VD10 cleared under Premarket Notification K143319 on February 24, 2015.
The following modifications are made to the cleared syngo X Workplace software version VD10 which created the Subject Device:
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- Updated Indications for Use Statement (Modification Affects: Labeling)
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- VD10 Software renamed to VD11 (VD10 software features of the predicate device remain the same). The "syngo Application Software" VD11 consists of features cleared as SW Version VD10 in K143319. VD11 is provided as software only on a CD/DVD. (Modification Affects: Labeling).
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- Provided update 510(k) information (see table below). The following minor modifications were made to the predicate device and are considered update 510(k) information for this submission.
The syngo Application Software VD11 may be installed either on Siemens released PC hardware or on Siemens X-ray systems also known as Siemens Angiography Systems. The combination of "syngo Application Software" and the Siemens released PC Hardware will be marketed as components of the "syngo X Workplace".
This 510(k) submission (K153346) for the "syngo Application Software VD11" is a modification of a previously cleared device (syngo X Workplace, K143319). The submission states that the modifications do not alter its fundamental scientific technology. Therefore, the acceptance criteria and study detailed below are primarily based on the claim of substantial equivalence to the predicate device and verification/validation testing of the modifications rather than a de novo clinical effectiveness study of the AI components.
Here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a modification of a predicate device with a focus on software updates and a renamed version, the "acceptance criteria" are predominantly related to the successful execution of non-clinical software verification and validation, and the continued conformance to recognized performance standards. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for an AI component are provided as acceptance criteria or reported device performance in this document. The document primarily focuses on ensuring the modified software functions as intended and safely as the predicate.
| Acceptance Criteria (Implied by Submission) | Reported Device Performance (Summary from Submission) |
|---|---|
| Conformance to performance standards (14971, 60601-1-6, 62304, 62366, NEMA PS3) | Siemens claims conformance to these standards. |
| Software documentation for moderate level of concern per FDA guidance. | Included as part of the submission. |
| Verification and Validation testing demonstrating continued conformance with special controls for medical devices containing software. | Nonclinical tests were conducted during product development. Testing results support that all software specifications have met the acceptance criteria. Testing for verification and validation was found acceptable to support claims of substantial equivalence. |
| Risk analysis completed and risk controls implemented to mitigate identified hazards. | Risk analysis completed and risk control implemented. |
| Cybersecurity requirements met (preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information). | Cybersecurity statement provided, considering IEC 80001-1:2010. |
| Functionality of the syngo Application Software VD11. | Performance tests were conducted, and results of all conducted testing were found acceptable. |
| Safety and effectiveness based on comparison to predicate device. | Non-clinical test results demonstrate that syngo Application Software VD11 acceptance criteria are adequate for the intended use and that the subject device is as safe and effective when compared to the predicate device. Clinical images (presumably from the predicate's clearance/historical data) were also found acceptable. |
The syngo Application Software VD11 features (software applications, standard/extended services, OEM software, integrated quantification, operating system, image archiving) are "Same" as the predicate. | The comparison table (pages 7-9) explicitly states "Same" for all listed technological characteristics between the subject device and the predicate device (syngo X Workplace SW VD10). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a dataset for a clinical performance study of an AI algorithm. Instead, it refers to "non-clinical tests" and "verification and validation testing" during product development. This likely involves testing different functionalities of the software on various configurations and with different types of medical images, but the exact sample size of images or test cases is not quantified or detailed.
The provenance of data used for these non-clinical tests is not specified (e.g., country of origin, retrospective/prospective). The mention of "clinical images" being found acceptable (page 10) likely refers to images used in functional testing or from the predicate's clearance, rather than a new clinical study for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. Given that the submission is for a software update and a claim of substantial equivalence, a new large-scale clinical study with expert-established ground truth for an AI component is not detailed. The "ground truth" for the non-clinical functional testing would be the expected output or behavior of the software based on its specifications, which would be established by internal engineering and quality assurance teams.
4. Adjudication Method for the Test Set
Not applicable, as a specific "test set" and ground truth establishment by experts in a clinical study sense are not described.
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 mentioned in this document. The device is described as "medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data... intended to assist the physician in diagnosis, treatment planning and treatment control." It facilitates existing diagnostic and interventional workflows but doesn't present itself as an AI-driven diagnostic aid that would typically warrant a comparative effectiveness study measure human reader improvement with/without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission does not describe a standalone performance study for an AI algorithm. The device is a comprehensive application software that facilitates image viewing and post-processing, implying human interaction is integral to its intended use.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the software's functional verification and validation, the "ground truth" would be the expected behavior or output of the software as defined by its design specifications and requirements. For any image processing or measurement functions, the ground truth would likely be established through reference software, manual measurements, or phantoms, rather than clinical ground truth like pathology or outcomes data in this specific 510(k) for a software update. The document mentions "clinical images were found acceptable," suggesting that previously established reference imaging or ground truth might have been utilized for assessment, but not detailed as a new ground truth establishment process for this submission.
8. The Sample Size for the Training Set
Not applicable. This submission is for a software update (renamed version VD11 with minor modifications to the predicate VD10) and does not describe the development or training of a new AI algorithm. The core functionality and software packages (e.g., syngo Dyna3D, syngo Needle Guidance) are stated to be the "Same" as the predicate device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no description of a new AI algorithm being developed or trained as part of this specific 510(k) submission.
§ 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).