(28 days)
The DR Systems PACS, Release 6.1 is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. The DR Systems PACS interfaces to various storage and printing devices using DICOM or similar interface standards.
The DR Systems PACS displays, stores, prints, and telecommunicates images from a number of medical modalities, including but not limited to MRI, CT, US, PET, DXA (bone densitometry), imaging, computed radiography, digital radiography, digitized films, digital photographs, mammographic images, and processed data from FDAcleared third party image processing systems, including FDA-cleared systems for computer-aided detection and advanced image processing (e.g. 3-D processed images such as those produced by Voxar Corp.).
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
The DR Systems Dominator Reading Station is a multi-modality PC-driven review workstation. It includes a color flat panel monitor and two or more high-resolution monitors, which may be high resolution CRT's or flat panel monitors. A standard keyboard is provided as well as a standard mouse. Optionally, a microphone may be attached.
DR Systems also provides components as described in the DR Systems User Guide, including:
- Ambassador Viewing Station Software typically used by referring doctors for viewing images, playing audio, or viewing reports, but not used for primary reading.
- Communicator Web Distribution Server.
- Guardian Archive System and optional DVD jukebox or EMC Centera archive.
- Catapult Technologist Workstation—for image and data input and editing as required.
- Universal Manager Workstations-primarily used by clerks for medical records and report management.
The DR Systems PACS, Release 6.1, provides the following features to the radiologist:
- DR Systems viewing software provides simple tools to enable display of any digital image at the same resolution as the initial acquired digital image, independent of the monitor matrix size.
- DR Systems provides several DICOM-compliant methods of lossless and lossy image compression (JPEG2000 and JPEG).
- The DR Systems PACS outputs DICOM medical image data to printers that adhere to appropriate regulatory standards.
- DR Systems archives medical imaging data in DICOM format on appropriate media (DVD, RAID servers, EMC Centera or other computer storage systems) that are designed to prevent data loss.
- DR Systems provides a software warning that identifies any image series where any image was not viewed prior to marking an examination as read, in order to prevent the reading physician from completing interpretation of an exam while inadvertently failing to view all images.
- DR Systems enables storage and reading of digitized images, including film-screen mammograms.
This document is a 510(k) Summary of Safety and Effectiveness for the DR Systems PACS, Release 6.1. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended use as a medical image and information management system, rather than presenting a study with specific acceptance criteria and performance metrics for a novel diagnostic algorithm.
Therefore, the requested information about acceptance criteria and a study proving a device meets them is not present in this document. The submission aims to show that the DR Systems PACS, Release 6.1, functions similarly to other PACS systems already on the market (Seno Advantage Windows Review Workstation and Sectra IDS5 Radiology Workstation).
Here's a breakdown of why the specific requested information cannot be provided from this document:
- A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for a diagnostic algorithm. It describes the features and functionalities of a PACS system.
- Sample size used for the test set and the data provenance: Not applicable, as no diagnostic performance study is described. The "test and design considerations, and planned verification and validation testing processes" mentioned are generic for a PACS system's functionality and safety, not for a specific algorithmic performance test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no diagnostic performance study requiring ground truth is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a PACS system, not an AI-powered diagnostic algorithm designed to assist human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a PACS system, not a standalone diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable, as this document does not describe a machine learning algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission is for a Picture Archiving and Communication System (PACS) and focuses on its functional equivalence to existing PACS devices. It does not contain information related to the performance of a diagnostic algorithm against specific acceptance criteria, or details regarding study design, ground truth establishment, or reader studies.
§ 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).