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The AX Workstation DR-Viewer Software Option offers the ability to visualize composite images of selected anatomy (i.e. spine, legs, colon). The images produced by the package, as well as the measurement tools of DR-Viewer, are intended to assist the physician in diagnosis and treatment of musculoskeletal disorders and conditions of the gastrointestinal tract.

The AX Workstation DR-Viewer Software Option uses a series of images of the anatomy (i.e. spine, legs, colon) generated with a radiographic, fluoroscopic, or angiographic x-ray system, and reconstructs the images into a single composite image format. After reconstruction of the image, the software provides the user with various measurement tools and post-processing functions.

This submission (K992925) for the Siemens AX Workstation DR-Viewer Software Option does not include a study proving the device meets acceptance criteria.

The provided documents are a 510(k) Premarket Notification submission from Siemens Medical Systems, Inc. to the FDA. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a clinical or performance study.

Here's why the requested information cannot be provided from this document:

• Nature of the Submission: 510(k)s are primarily about demonstrating that a new device is as safe and effective as (substantially equivalent to) an already legally marketed device. They rarely include detailed performance studies with pre-defined acceptance criteria, sample sizes, and expert ground truth establishment for a new, unproven technology. Instead, they often rely on bench testing, comparison to predicate device specifications, and sometimes limited clinical data for specific functions.
• Device Type: The DR-Viewer Software Option is described as a software feature that reconstructs and visualizes composite images from angiographic data and provides measurement tools. Its primary function is image processing and display, which typically relies on demonstrating accuracy of reconstruction, accurate measurement tools, and user interface validity, rather than clinical diagnostic accuracy studies with human readers.
• Content of the Document: The document focuses on identifying the device, its classification, predicate devices, and indications for use. There is no mention of a formal performance study with acceptance criteria, sample sizes, expert involvement, or adjudication methods.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details because the provided K992925 submission does not contain such information.

The document serves to notify the FDA of intent to market and to establish substantial equivalence with predicate devices, which are:

• Philips EasyVision Family Workstation Legs Option (K990455)
• Philips Spine Option for Easy Vision Workstation (K963980)

The "Indications For Use" (Attachment 9) states: "The AX Workstation DR-Viewer Software Option offers the user the ability to visualize composite images of selected anatomy (i.e. spine, legs, colon). The images produced by the package, as well as the measurement tools of DR-Viewer, are intended to assist the physician in diagnosis and treatment of musculoskeletal disorders and conditions of the gastrointestinal tract." This describes the intended application, but not performance metrics or acceptance criteria.

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