(17 days)
syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
The syngo US Workplace is used to view images, to store and print images, and to make measurements on images using a personal computer. The software is userinstallable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the software by CD-ROM and DVD or a network connection.
This 510(k) submission (K060992) for the syngo US Workplace does not contain a study that establishes acceptance criteria or reports on device performance against such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's absolute performance against predefined acceptance criteria through specific studies. The core of this submission is the claim that the "syngo US Workplace is substantially equivalent to the Siemens family of ultrasound imaging systems and the TomTec Image Arena (K040546)."
The description of the device's function involves viewing, storing, printing, and making measurements on ultrasound images. The FDA's acceptance of the 510(k) indicates that they found the device "substantially equivalent" to existing and legally marketed predicate devices, implying it meets similar safety and effectiveness standards as those predicates. However, there is no detailed study within this document that provides specific performance metrics (e.g., accuracy of measurements, speed of image rendering) or defines acceptance criteria for these metrics.
Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.
Here's what can be extracted from the document:
- Device Name: syngo® US Workplace
- Purpose of the Device: To view post-processed ultrasound images, store and print images, and manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.
Missing Information (Not provided in the document):
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the 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).