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The V-works is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

The V-works™ is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, mocess, render, review, store, print and distribute DICOM 3.0 complaint image process, reliaer, 101107, 1011, 1978, dware. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft personal compacer pratessional/NT 4.0 operating system makes the V-works™ software easy to use and capable of being integrated with other computer needs.

The provided text is a 510(k) Summary for the CyberMed Inc., V-works™ device. It describes the device, its intended use, and its substantial equivalence to a predicate device (Voxar Limited Plug'n View 3D). However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way a clinical validation study typically reports it.

The document focuses on establishing substantial equivalence based on technical characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample sized used for the test set and the data provenance: This information is not present in the document.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
• Adjudication method for the test set: This information is not present in the document.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size: This information is not present in the document.
• If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document.
• The type of ground truth used: This information is not present in the document.
• The sample size for the training set: This information is not present in the document.
• How the ground truth for the training set was established: This information is not present in the document.

The document mainly emphasizes that the V-works™ software is "designed, developed, tested and validated according to written procedures" and that "hazard analysis on this product has been performed throughout the definition, design, coding and testing phases." It concludes that the "Level of Concern" is "Minor" and that potential hazards are similar to other PACS components and unlikely to result in patient death or injury. This reflects a software development and risk management approach, not a clinical performance study as typically seen for AI/CAD devices.

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