(73 days)
The SECTRA MS4 device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.
The IDS4 series will be used for displaying and handling of radiological images.
This document is a 510(k) summary for the SECTRA-Imtec IDS4 Image Display System series, which was reviewed by the FDA in 1997. It declares substantial equivalence to a predicate device (SECTRA-Imtec TRS 2000, K961983) and outlines the system's intended use for displaying and handling radiological images by trained medical professionals.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of specific numerical acceptance criteria or reported device performance metrics for the IDS4 Image Display System. The 510(k) summary focuses on demonstrating substantial equivalence based on compliance with regulations, voluntary standards, user guides, and hazard analysis, rather than quantitative performance data.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size or data provenance for any test set. The claim of substantial equivalence is based on regulatory compliance and comparison to a predicate device, not on clinical performance testing with a specific dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention a test set with corresponding ground truth established by experts.
4. Adjudication method for the test set
The document does not describe any adjudication method for a test set.
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
The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is an "Image Display System," suggesting its primary function is display and handling of images, not AI-driven analysis or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe any standalone algorithm performance testing. The device is an "Image Display System" intended for use by "trained medical professionals," implying human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not mention the use of any specific type of ground truth data.
8. The sample size for the training set
The document does not mention any training set or its sample size.
9. How the ground truth for the training set was established
The document does not mention any training set or how its ground truth was established.
Summary of what is present in the document:
The provided text is a 510(k) summary submitted to the FDA for the IDS4 Image Display System. It asserts substantial equivalence to a predicate device (SECTRA-Imtec TRS 2000, K961983) by stating:
- Compliance with Federal Performance Standards (21 CFR, part 1000).
- Manufacturing in accordance with voluntary standards.
- Comprehensive information in user guides for safe and effective use.
- Results of a hazard analysis are included.
The FDA's response confirms the device is substantially equivalent based on the provided information and allows marketing of the device. The indications for use are for the manipulation and displaying of x-ray images from different modalities, with options for telecommunications, fast demonstration, prosthesis CAD, 3-D and angiography, etc., and teleconferencing. The typical users are trained medical professionals.
In conclusion, the document is a regulatory submission for pre-market notification (510(k)) and focuses on demonstrating substantial equivalence through compliance with regulations and standards rather than presenting detailed clinical performance studies, acceptance criteria tables, or data provenance. Therefore, most of your specific questions cannot be answered from the provided text.
{0}------------------------------------------------
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
21 March 1997 K971368
SECTRA Doc. no: 3-97.202-1.0
JUN 26 1997
510(k) summary of safety and effectiveness information for the SECTRA-Imtec IDS4 Image Display System series
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The IDS4 series will be used for displaying and handling of radiological images. The typical users are trained medical professionals at a radiology department.
The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to SECTRA-Imtec TRS 2000 (K961983). This information and data is summarised as follows:
-
- The IDS4 series is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
-
- The IDS4 series has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
-
- The IDS4 series User's Guides contains comprehensive information on how to operate the system to ensure a safe and effective use.
-
- The submission contains the results of an hazard analysis.
Pet And
Peter Andersson Regulatory Manager SECTRA-Imtec AB Linköping, Sweden Telephone: +46 13 23 52 00
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "HUMAN SERVICES USA" at the top and "DEPARTMENT OF HEALTH" at the bottom. In the center of the circle is an abstract image of three human profiles facing to the right, with flowing lines beneath them that resemble water or fabric.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1997
Sectra-Imtec AB c/o Herman Oosterwiiki President Otech, Inc. 6741 Grant Lane Plano, TX 75024
Re: K971368 IDS4 Image Display System Series Dated: April 9, 1997 ... ... Received: April 14, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Mr. Oosterwijki:
We have reviewed your Secsion 510(k) notification of intent to market the device and we have desemined 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 enactment date of the Medical 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 precise, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premates Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Feceral Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices 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(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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,
William Yu
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
{2}------------------------------------------------
າ , ບວ
Page 1 of -1
510(k) Number: K971368
Device Name: IDS4 (Image Display System), by SECIRA-Imtec AB
Indications For Use:
The SECTRA MS4 device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
(PLEASE DO NOT WRITE DELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109) OR
Over -The-Counter Use
(Optional Format 1-2-96)
David A. Sejmon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
§ 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).