(126 days)
3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc.
Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.
Digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images must not be interpreted using this system.
3viseon/surgery™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital Mammograms). 3surgery is an advanced 2D and 3D visualization solution that enables surgeons to quickly and reliably prepare for various types of surgery, by combining 2D scan slices into comprehensive 3D models of the patient.
The software device should not be used during a surgical procedure.
3viseon/surgery™ works with all major medical image formats and can access multiple data stores, across networks or on CD-ROM / DVD. The software runs on any modern Windows based computer with a 3D graphics card that meets the minimum requirements, eliminating the need for specialized hardware.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the 3viseon/surgery™ device:
Important Note: The provided 510(k) document is a summary of safety and effectiveness, and primarily focuses on establishing substantial equivalence to predicate devices. As such, it does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria in the way a more comprehensive study report or clinical trial would. The 510(k) process for this type of device (Picture Archiving Communications System, Image Processing) often relies on demonstrating that the new device's technological characteristics and intended use are similar enough to existing legally marketed devices, implying similar safety and effectiveness without requiring extensive new performance data.
Therefore, the answers below will reflect the information available in the provided document, and will explicitly state when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, specific numerical acceptance criteria and corresponding reported device performance metrics are not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided 510(k) summary. The summary focuses on functional similarities and capabilities with predicate devices rather than quantifiable performance metrics against pre-defined criteria. | Not explicitly stated in the provided 510(k) summary for direct comparison against performance acceptance criteria. The document highlights features like 2D review, MPRs, vascular measurements, etc., but doesn't provide quantitative results demonstrating their performance. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the 510(k) summary. There is no mention of a specific test set, its sample size, or the provenance of any data used for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. No details are given about a test set, ground truth establishment, or the involvement of experts in such a process.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. As no test set for performance evaluation is described, an adjudication method is also not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not reported in this 510(k) summary. The device, 3viseon/surgery™, is described as a "software based application for picture archiving and communications system" and "advanced 2D and 3D visualization solution." Its purpose is to prepare 3D models and provide various visualization tools for surgeons. The summary explicitly states: "Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals." This indicates it's a visualization and processing tool, not an AI-assisted diagnostic or interpretation tool meant to augment human reader performance in a diagnostic task.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
A standalone performance evaluation of the algorithm was not done or is not reported in this 510(k) summary. Given the device's function as an imaging and visualization tool (i.e., PACS software) where "Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals," a standalone performance study in the context of diagnostic accuracy would not be applicable or expected for this type of device classification.
7. The Type of Ground Truth Used
This information is not provided in the 510(k) summary. As no specific performance study with a test set is discussed, the type of ground truth used is not mentioned.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document does not describe the use of machine learning or AI that would typically involve a training set. The device is presented as a software application for image processing and visualization.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary. As no training set is discussed, the method for establishing its ground truth is also not mentioned.
Summary of the Study Information:
The provided 510(k) summary for 3viseon/surgery™ primarily focuses on demonstrating substantial equivalence to predicate devices (VOXAR 3D ENTERPRISE, MODEL 6.1 and 3VISEON) by outlining its technological characteristics and intended use. The document does not describe a specific performance study with defined acceptance criteria, test sets, or ground truth methodologies. The device's classification as a "Picture Archiving Communications System" and "System, Image Processing" indicates its role as a tool for managing, processing, and visualizing medical images, rather than an AI-driven diagnostic aid that would typically require extensive performance studies against ground truth. The submission likely relied on design controls, software validation, and a comparison of features to establish equivalence, rather than a prospective clinical performance study.
§ 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).