(86 days)
MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.
MAMMOVISTA B.smart is an optional software application for the Siemens Healthineers syngo.via platform (K191040). MAMMOVISTA B.smart is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of digital tomosynthesis and the display of multi-modality breast images, such as those from MRI and ultrasound. Individual workflows can be adapted for either screening or diagnostic purposes.
MAMMOVISTA B.smart runs on a PC and can be used for Mammography image review together with monitors cleared for Mammography diagnostics. The software solution provides for the display of DICOM compatible information, such as breast density and CAD (Computer Aided Diagnostics) markers.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device (MAMMOVISTA B.smart) and primarily focuses on establishing substantial equivalence to a predicate device.
Specifically, the document states:
- "Non-clinical tests (integration and functional) were conducted on the MAMMOVISTA B.smart during product development. The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence." (page 7)
- "Siemens did not conduct any clinical tests for the subject device." (page 7)
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Information on a standalone performance study, as clinical tests were not conducted.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document only states that "all the software specifications have met the acceptance criteria" based on non-clinical (integration and functional) tests and risk analysis, but it does not detail those criteria or the specific results of these tests. It explicitly states no clinical tests were performed.
§ 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).