(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.
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JUL 20 1998
Summary Of Safety and Effectiveness 2
This summary of 510(k) safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter :
Algotec systems Ltd. 4 Hamelacha St. P.O Box 2408 Industrial zone Raanana ISRAEL 43000 Tel : +972 - 9 - 7482442 Fax : +972 - 9 - 7482411
Name of the Device: Software updates on ProVision.
Predicate Device : ProVision diagnostic Workstation Manufactured by Algotec Systems Ltd.(K954678).
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Description of the Device: 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.
Intended use: The systems is intended for use by radiologists as an interactive tool for analyzing radiological data. -
Comparison of Technological Characteristics: The new updates made on the Provision workstation share the same software and hardware backbone as the original applications. They are an inherent part of the workstation and share the identical system resources. 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.
February 10, 1998
DR Menashe Benjamin, President
1980648-
Date
Signature, Title
Meher Bey
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1998
Algotec Systems, LTD c/o Eli M. Orbach International Regulatory Consultants P.O. Box 6718 Efrat 90435 Israel
Re:
K980648 ProVision (Diagnostic Workstation) Dated: May 27, 1998 Received: May 29, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Orbach:
We have reviewed your Section 5100k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the exactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Felections, Title 21. Parts 800 to 895. A substantially equivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for derices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html",
Sincerely yours,
Kilian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (K) Number (if known):K980648
Device Name: ProVision Workstation
Indications for use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seggern
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological De 510(k) Number
Prescription use _ × (Per 21 CFR 801.109)
OR
Over The Counter Use_ Format 1-2-96) (Optional
§ 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).