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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.

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.

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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:

1. 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.
2. Sample size used for the test set and the data provenance: No test set is described, nor is any study involving such a set.
3. 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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or adjudication is mentioned.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is mentioned.
7. 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.
8. 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.
9. How the ground truth for the training set was established: Not applicable.

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