(129 days)
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
The OnePacs System is an image management system intended to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems.
The OnePacs system is a software only product and does not include any hardware accessories or peripheral devices. It is designed to work on generic PC hardware that meets minimum system requirements.
The OnePacs System is comprised of following main interrelated software elements/ components:
- OnePacs Cloud (OPS)
- OnePacs Workstation (OPW)
- OnePacs Workstation for macOS (OPX)
- OnePacs Webviewer (OPWEBV)
- OnePacs Study Retriever (OPSR)
- OnePacs Gateway (OPG)
The OnePacs System is an image management system intended to provide scalable DICOM compatible PACS solutions for hospitals and related institutions.
Here's an analysis of its acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the "Technological Characteristics and Substantial Equivalence" section (pages 4-6) serves as the primary means to demonstrate the device meets its intended purpose by comparing its features and functionalities to legally marketed predicate devices. The implicit acceptance criteria are that the OnePacs System performs comparably to or better than the predicate devices across a comprehensive set of PACS functionalities and adheres to relevant standards.
The table below summarizes the key functionalities and the OnePacs System's reported performance (implicitly, that it possesses these functionalities):
| Acceptance Criteria (Functionality/Standard Adherence) | Reported Device Performance (OnePacs System) |
|---|---|
| Image management system for various modalities (CR, CT, DR, MR) | Yes, archives, distributes, retrieves, and displays images and data from all hospital modalities. |
| Display of structured reports | Yes |
| Display of mammography images (DICOM "For Presentation") | Yes, includes standard features and tools for analyzing mammography images. |
| Restriction: Lossy compressed mammographic images and digitized film screen images for primary diagnosis | Must not be reviewed for primary diagnosis or image interpretation. |
| Restriction: Mammographic images for primary diagnosis | Post-process DICOM "for presentation" images must be used. |
| Restriction: Monitor for mammographic images | Should only be viewed with an FDA-approved monitor for viewing mammographic images. |
| DICOM compatibility (Query, Import, Send, Receive DICOM images) | Yes |
| Image Printing | Yes |
| Export of DICOM images to optical media | Yes |
| Reporting (save, email, DICOM send, print to standard printers) | Yes |
| Image analysis tools (W/L, zoom, pan, stack, move, rotate, flip, delete) | Yes |
| Measurement and annotation | Yes |
| Multi-monitor awareness | Yes |
| Image layout | Yes |
| Image thumbnails | Yes |
| Reference lines and spatial locator for tomographic images | Yes |
| User annotations of images | Yes |
| Synchronized stacking | Yes |
| Probe tool | Yes |
| Shutters | Yes |
| Key image marking | Yes |
| Multiplanar Reformat (MPR) | Yes |
| Lossy and lossless compression | Yes |
| Automatic routing of images | Yes |
| Image archiving | Yes |
| Patient information and workflow management components | Yes |
| Image streaming from server | Yes |
| Enterprise distribution of images and data via Internet or Intranet | Yes |
| Web-delivered viewing software | Yes |
| Conformity to NEMA PS 3.1 - 3.20 (2016) Digital Imaging And Communications In Medicine (Dicom) Set | Yes |
| Conformity to IEC/ISO 10918-1, Edition 1 (1994-02-15), Information Technology - Digital Compression And Coding Of Continuous-Tone Still Images | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an algorithmic performance evaluation. The "performance testing" referenced is primarily "comprehensive software validation" and compliance with standards. There is no mention of a specific dataset of medical images or patient cases used to test the device's diagnostic accuracy or functionality beyond standard software testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no specific test set for algorithmic performance was described, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set
Not applicable. No test set for algorithmic performance was described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The submission does not contain any data from clinical testing."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire submission focuses on the OnePacs System as an image management system which includes software components for archiving, distributing, retrieving, and displaying images, as well as tools for analyzing them. It is not an AI or algorithm-only device designed for standalone diagnostic interpretation. Therefore, a "standalone algorithm only" performance study in the sense of an AI interpreting images was not done. The device's functionality is inherently intended to be used by a human (e.g., a radiologist).
7. The type of ground truth used
For the software validation and adherence to standards, the "ground truth" would be the successful execution of functions as per design specifications and compliance with DICOM and JPEG standards. There is no mention of ground truth based on expert consensus, pathology, or outcomes data for diagnostic accuracy.
8. The sample size for the training set
Not applicable. The OnePacs System is an image management system, not a device employing machine learning or AI that requires a "training set" of medical images for learning diagnostic patterns. Its "training" would be the software development and testing process.
9. How the ground truth for the training set was established
Not applicable, as no training set (for machine learning) is relevant to this device's description.
§ 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).