(57 days)
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used. syngo.plaza also supports DICOM Structured Reports. In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo.plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image distribution is not intended for reporting.
syngo plaza is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. syngo.plaza will be installed by Siemens service engineers. The backend communication and storage solution is based in Windows 2008 operating systems as described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519) The syngo plaza will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be I any spond individual service contract and fulfilled by special trained service technicians. This is also applicable for the predicate devices syngo.plaza VA10A (093612) and syngo.x (K092519). The herewith described syngo plaza VA20A supports DICOM formatted images and This which is also described for the predicate devices syngo.plaza VA10A (093612), syngo.x (K092519) and syngo Imaging (K071114).
The provided text describes the syngo.plaza VA20A, a Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically found in performance studies for AI/CADe devices.
The document is a 510(k) summary for a PACS system, which primarily focuses on stating substantial equivalence to predicate devices based on intended use and technical characteristics, rather than detailed performance metrics of a novel algorithm or diagnostic aid.
Here's a breakdown of what is and is not present, based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document describes the system's functionalities (display, process, read, report, communicate, distribute, store, and archive digital medical images) and states that software verification and validation were performed according to various standards (DICOM, JPEG, ISO, IEC, HL7). It concludes that "Siemens is of the opinion, that syngo plaza is substantially equivalent to and performs as well as the predicate device." There are no quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance criteria for such metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No specific test set, sample size, or data provenance is mentioned as this is not a clinical performance study of an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. Ground truth establishment is not relevant in this context, as there's no clinical performance study reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. Not applicable.
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:
- Not provided. No MRMC study is mentioned. The device is a PACS system, not an AI or CADe product designed to assist human readers in a diagnostic task in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. Not applicable, as this is a PACS system and not a standalone AI algorithm with diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. Not applicable.
8. The sample size for the training set:
- Not provided. Not applicable, as this is a PACS system, not an AI algorithm that undergoes specific training on a dataset.
9. How the ground truth for the training set was established:
- Not provided. Not applicable.
In summary, the provided document is a regulatory submission (510(k) summary) for a PACS system (syngo.plaza VA20A) demonstrating its substantial equivalence to previously cleared predicate devices. It focuses on functional descriptions, compliance with technical standards, and risk management, rather than detailed performance studies of an AI diagnostic component as would be required for a device claiming to interpret images or assist in diagnosis via AI/CAD.
§ 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).