(10 days)
3viseon™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored. communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
3viseon™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, fransfer, display, storage, and digital processing of medical images (including digital Mammograms).
The 3viseon software allows you to select patient series from various data sources, view them in 2D or 3D mode and process the images with the help of a comprehensive set of tools:
- Data Management for a detailed description on how to select patient studies from one or more data sources;
- 2D Viewing Mode - for a detailed description on how to view images in 2D mode and process them:
- -3D Viewing Mode - for 3D imaging.
This 510(k) summary for the 3viseon™ device does not contain acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) submission which primarily focuses on demonstrating substantial equivalence to a predicate device (Plug" n View 3D™ by Voxar Limited). It describes the device, its intended use, and its technological characteristics. The letter from the FDA confirms the substantial equivalence determination.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here is a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the device's capabilities (viewing, processing images) but does not define specific performance metrics or acceptance criteria for those capabilities, nor does it provide a report of measured performance against such criteria.
- Sample size used for the test set and the data provenance: No test set is described, nor is any study involving such a set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or adjudication is mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC comparative effectiveness study is not mentioned. The device is described as an image processing and display system, not an AI-assisted diagnostic tool in the sense of providing specific interpretations or aiding human readers in decision-making beyond image presentation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is mentioned in relation to performance evaluation.
- The sample size for the training set: Not applicable. The document describes a software application, not a machine learning model that would require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).