(190 days)
syngo.MR Oncology is a syngo.via-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngo.via supports.
syngo.MR Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow-up documentation of findings.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.MR Oncology is a tool to support the standard practices and visual comparisons.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
In addition to the reading and reporting functions/tools that are available in the predicate syngo.via basic software configuration, Siemens Healthcare intends to offer MR specific workflow configurations that are adapted for MR Oncology (syngo.MR Oncology).
syngo.MR Oncology is a syngo-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application supporting convenient reading of MR scans of single or multiple body regions, up to the entire body which have been acquired for clinical purposes such as oncological screening, diagnosis and staging.
The medical device software syngo.MR Oncology consists of the following two applications: syngo.MR Onco Workflows and the syngo.MR 3D Lesion Segmentation Tool.
The syngo.MR Onco Workflow application consists of the following tools: MR Onco Multi-Region, MR Onco Liver, MR Onco Brain, MR Onco TimCT and an Onco report.
The syngo.MR 3D Lesion Segmentation Tool also known as MR Segmentation tool, is a tool using the Random walker algorithm (default algorithm) or the Level Set algorithm. 3D Lesion Segmentation provides convenient volumetric evaluation of lesions and/or other structure of interest as well as a particularly useful tool for oncology applications (for example volumetric evaluation of tumors, lymph nodes and metastases), and nononcology lesions or other structures of interest with sufficient contrast to surrounding tissue.
This 510(k) summary for syngo.MR Oncology highlights substantial equivalence to predicate devices but does not include a dedicated study to prove that the device meets specific acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table with acceptance criteria versus reported device performance, nor can I elaborate on sample sizes, ground truth establishment, or multi-reader multi-case studies, as these data points are not present in the provided document.
The document focuses on:
- Device Description and Intended Use: Explaining what syngo.MR Oncology is, its components (syngo.MR Onco Workflows and syngo.MR 3D Lesion Segmentation Tool), and its purpose in oncological MR image evaluation.
- Safety and Effectiveness Concerns: Discussing risk management via ISO 14971:2007 and adherence to industry practices and standards, but without specific performance metrics.
- Substantial Equivalence: Listing predicate devices (syngo MR B17, syngo.x (syngo.via), syngo PET&CT Oncology, Syngo Dosimetrist Workspace v2.7) and stating that modifications to the predicate devices do not affect intended use or fundamental scientific technology.
Without a specific study described in the provided text, I cannot extract the information required for your request. This includes:
- Acceptance criteria and reported device performance: Not specified.
- Sample size and data provenance for the test set: Not specified.
- Number of experts and qualifications for ground truth: Not specified.
- Adjudication method for the test set: Not specified.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance: Not mentioned.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not specified.
- How ground truth for the training set was established: Not specified.
The provided text from the 510(k) K111861 primarily serves to establish legal clearance based on substantial equivalence to existing devices, rather than presenting detailed performance study results against predefined 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).