(49 days)
Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM and other medical images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Advanced 3D Web PACS™ is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information,
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammodraphic 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
Advanced 3D Web PACS™ is a PACS system, comprised of acquisition components (Medweb secure DICOM Proxy Web Server, ), a central system manager component (Medical Transcription Server), a diagnostic workstation component (Radiologist Dashboard©), and an archiving component (DICOM Archive). The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once Advanced 3D Web PACS™ central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
This 510(k) summary for the Advanced 3D Web PACS™ system does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is present:
Missing Information:
- Table of Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative or qualitative acceptance criteria for the device's performance, nor does it provide any reported performance metrics against such criteria.
- Sample size and data provenance for the test set: No information on a test set, its size, or data provenance is provided.
- Number of experts and qualifications for ground truth: No experts or ground truth establishment are mentioned.
- Adjudication method: Not applicable as no ground truth establishment is described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.
- Standalone (algorithm-only) performance study: Not applicable as the device is a PACS system for image management, not a diagnostic algorithm with standalone performance metrics.
- Type of ground truth used: No ground truth is mentioned.
- Sample size for the training set: No training set is mentioned.
- How ground truth for the training set was established: Not applicable as no training set or ground truth is mentioned.
Information Present in the Document:
This document is a 510(k) summary for a Picture Archiving and Communications System (PACS). Its primary purpose is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.
The key points from the summary are:
- Device Name: Advanced 3D Web PACS™ Picture Archiving and Communications System
- Applicant: Nexsys, Inc., dba Medweb, LLC
- Intended Use: A PACS and teleradiology system used to receive, organize, store, and make medical images, scheduling information, and textual reports available across a network. It is for hospitals, imaging centers, radiologist reading practices, and authorized users.
- Software Development: Nexsys certifies that the software is designed, developed, tested, and validated according to written procedures.
- Safety and Effectiveness:
- Labeling contains instructions, warnings, and cautions.
- User responsibility to ensure display quality and environmental lighting.
- "Level of concern" is "minor" as the failure or latent design flaw of the software or "off the shelf" hardware components is not expected to result in death or injury.
- Substantial Equivalence: The device is deemed substantially equivalent in design and intended use to predicate devices such as AccuImage AccuView (K990241), Neo Imagery Technologies Insight Diagnostic Imaging Workstation (K982535), and Picker Voxel Q™ and Voyager™ (K962010). The document states that "all of the functions that Advanced 3D Web PACS™ performs are available in at least one of the listed substantially equivalent devices."
- Limitations: 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 with at least 5 Mpixel resolution and other technical specifications.
In summary, this document is a regulatory submission focused on demonstrating equivalence and safe operation for a PACS system, not a clinical validation study with specific performance metrics and acceptance criteria.
§ 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).