(102 days)
The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.mMR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.
syngo.mMR General is a syngo.via-based post-processing software / application to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
The provided text is a 510(k) summary for syngo.mMR General, a post-processing software. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a clinical study with reported performance metrics like sensitivity and specificity.
Therefore, the document does not provide the specific information you are asking for regarding acceptance criteria, a study proving the device meets those criteria, or details such as sample sizes for test/training sets, expert qualifications, or adjudication methods in the context of a performance study demonstrating diagnostic accuracy.
The document states:
- "Siemens is of the opinion that the syngo.MR post-processing application does not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed device syngo.MR Post-Processing Software Version SMRVA16B (K133401 cleared on March 11, 2014)" {3}.
- "The syngo.MR post-processing application is intended for similar indications as cleared in the predicate device." {3}.
- "There are minor changes to the indications for use for the subject device with regards to syngo.mMR General. The differences give the device greater capabilities than the predicate, but the technological characteristics and functionalities are similar." {3}.
This type of submission relies on demonstrating that the new device has "substantially equivalent" technological characteristics and indications for use to a previously cleared device, not on presenting novel performance data against specific acceptance criteria.
Therefore, I cannot populate the table or answer most of your questions as the information is not present in the provided text. The document focuses on showing substantial equivalence to a predicate device, which is a different regulatory pathway than providing a performance study against specific acceptance criteria.
§ 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).