(151 days)
ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device. ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.
The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.
The provided text does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria. The document is a 510(k) summary for a software update to a diagnostic workstation (ProVision) and focuses on demonstrating substantial equivalence to a predicate device.
However, based on what is provided, here's a breakdown of the requested information, acknowledging the limitations of the input text:
1. A table of acceptance criteria and the reported device performance
The document states: "The new updates simply provide quicker methods to reach results that would have been time consuming on the previous version of Pro Vision software. The addition of these software updates raises no new issues of safety or effectiveness."
This implies that the key performance criteria for the update are related to efficiency/speed and maintaining safety and effectiveness at least equivalent to the predicate device. However, no quantitative acceptance criteria or specific performance metrics are reported in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficiency/Speed: Improved speed in reaching results compared to the previous version. | The new updates "simply provide quicker methods to reach results that would have been time consuming on the previous version of ProVision software." |
| Safety and Effectiveness: No new issues of safety or effectiveness introduced. | "The addition of these software updates raises no new issues of safety or effectiveness." |
| Functionality: Maintain all existing functionalities of the ProVision workstation. | The updates are "an inherent part of the workstation and share the identical system resources." "They are an inherent part of the workstation and share the identical system resources." |
| Technological Characteristics: Share the same software and hardware backbone as the original applications. | "The new updates made on the Provision workstation share the same software and hardware backbone as the original applications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text. The document refers to the system's intended use "by radiologists as an interactive tool for analyzing radiological data," but doesn't detail any expert involvement in a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
5. 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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The document focuses on software updates for an existing diagnostic workstation, emphasizing efficiency improvements and substantial equivalence, not the comparative performance of human readers with vs. without AI assistance. The device is described as "an interactive tool for analyzing radiological data," implying human-in-the-loop, but no comparative study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, ProVision, is described as an "independent diagnostic viewing and processing workstation" and an "interactive tool for analyzing radiological data." This inherently implies a human-in-the-loop system. Therefore, a standalone (algorithm only) performance study would likely not be relevant or described for this type of device, and there is no mention of one.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given text.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given text.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence for software updates to an existing diagnostic workstation. It asserts that the updates improve efficiency and do not introduce new safety or effectiveness issues. However, it lacks detailed information regarding specific study designs, acceptance criteria, sample sizes, expert involvement, or ground truth establishment that would typically be found in a comprehensive performance study report. The claims are high-level and refer to the inherent nature of the updates within the existing system.
§ 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).