(84 days)
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
It supports the physician in diagnosis and treatment planning.
syngo Imaging XS also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngoImaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.
syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Note:
Web based image distribution is not intended for reporting.
syngo Imaging XS does not support the display of mammography images for diagnosis.
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo Imaging XS also supports storage and archiving of Structured DICOM Reports. In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. syngo Imaging XS optionally uses a variety of advanced postprocessing applications. syngo Imaging XS (version V70) is a "software only"-system, which will be delivered on CD-ROM / DVD or also preconfigured on hardware. syngo Junasing XS will be instilled by Siemens service engineers. Defined Hardware requirements are to be met. The herewith described syngo Imaging XS supports DICOM formatted images and objects.
The provided text describes a 510(k) summary for the syngo Imaging XS (version V70) Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or the various study design elements requested in your prompt.
The document primarily focuses on establishing substantial equivalence to predicate devices, general device description, intended use, and regulatory classification. It mentions that "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." However, it does not provide details on the specific tests or their results.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
Here's a breakdown of why the information is missing:
- Acceptance Criteria & Device Performance: The document states the device performs "as well as the predicate devices" but does not define specific metrics or criteria against which this performance is measured.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Ground Truth Type, Training Set Size & Ground Truth: These are all elements typically found in detailed performance studies. The provided text is a regulatory summary, not a technical study report, and therefore these details are absent.
To answer your questions, I would need a different type of document, such as a detailed clinical validation report or a technical performance study report that would typically be referenced or summarized within a more comprehensive 510(k) submission, but is not present in the excerpt you provided.
§ 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).