Search Results

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.

Ask a specific question about this device

Intended for use to independently review and process anglographic images outside the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different modalities for the same patient on the same workstation to further support diagnosis and treatment planning.

Not Found

The provided text is a summary of a 510(k) premarket notification for the "AX Workstation," an angiographic x-ray system. This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting detailed acceptance criteria and a study proving performance against them in the way a clinical trial for a novel AI diagnostic might.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and detailed study methodologies is not present in the provided text. The document is primarily concerned with regulatory clearance based on the device's functional similarity to existing and legally marketed devices.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) submission focuses on demonstrating "substantial equivalence" of the new device to existing predicate devices (Siemens TOP ACOM Station and Camtronics Analytical Review Station). Substantial equivalence means that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve presenting specific, quantitative acceptance criteria met through a performance study in the same way a de novo device or a novel AI algorithm might.

The "performance" described is functional similarity: "Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions." This is a statement of intended functionality, not a metric with an acceptance threshold.

2. Sample size used for the test set and the data provenance:

• Sample size for the test set: Not provided. No specific test set or associated sample size is mentioned.
• Data provenance: Not applicable/Not provided. Since no specific test set is detailed, there's no information on data provenance (e.g., country of origin, retrospective/prospective). The document implies the functionalities are derived from existing Siemens angiography systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not provided.
• Qualifications of experts: Not provided.

This type of information is usually relevant for studies validating diagnostic accuracy, which is not the primary focus of this 510(k) for a review workstation.

4. Adjudication method for the test set:

• Adjudication method: Not provided. As no test set is detailed, no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC study: Not provided. The document describes a "review workstation" for angiographic images, which provides image processing and viewing functions. It does not describe an AI algorithm or a comparative effectiveness study involving human readers with and without AI assistance. The term "AI" is not present in the document.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone performance study: Not provided. This device is a workstation designed for human interaction and review; it's not described as a standalone algorithm performing automated diagnosis.

7. The type of ground truth used:

• Type of ground truth: Not applicable/Not provided. As there's no described performance study requiring a ground truth (e.g., for diagnostic accuracy), no type of ground truth is mentioned. The device's purpose is to assist diagnosis, not to make a diagnosis itself, implying human experts will establish the final diagnostic ground truth in clinical practice.

8. The sample size for the training set:

• Sample size for the training set: Not provided. This document does not describe any machine learning or AI components that would require a "training set."

9. How the ground truth for the training set was established:

• Ground truth establishment for training set: Not applicable/Not provided. Since no training set is described, no method for establishing its ground truth is mentioned.

Ask a specific question about this device