(270 days)
The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The MIVD 1218 is a diagnostic display. The MIVD 1218 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This document describes the 510(k) summary for the Barco MIVD 1218, an 18-inch grayscale display module. It's important to note that this is a display device, not an AI or image processing algorithm in the modern sense. Therefore, many of the typical AI/ML acceptance criteria and study components will not apply.
Based on the provided text, the device is a medical display, and the "study" demonstrating its performance would primarily involve technical specifications and conformance to industry standards for medical displays, rather than a clinical trial with patient data or expert read comparisons.
Here's an attempt to address your points based on the available information, noting where information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly detail a table of acceptance criteria or a "reported device performance" in the context of a clinical study assessing diagnostic accuracy. For a display device like this, acceptance criteria would typically revolve around technical specifications such as resolution, luminance, contrast ratio, uniformity, viewing angle, and compliance with standards like DICOM Part 14.
The document states:
- Proprietary Name: MIVD 1218
- Device Description: The MIVD 1218 is a diagnostic display
- Technological Characteristics: The MIVD 1218 device is a high-resolution monitor with electronic capabilities for evaluation of high-resolution medical images.
Without access to the full 510(k) submission, we cannot provide specific numerical values for these technical performance metrics. The core "performance" for a display is that it accurately and consistently presents medical images within specified parameters.
| Acceptance Criterion (Inferred for a Medical Display) | Reported Device Performance (Inferred from description) |
|---|---|
| High Resolution Capability | "high-resolution monitor" |
| Electronic Capabilities for Medical Imaging | "electronic capabilities for evaluation of high-resolution medical images" |
| Compliance with relevant medical display standards (e.g., DICOM Part 14) | Presumed to be met for 510(k) clearance, but not explicitly stated in this summary. |
| Intended Use fulfillment (displaying digital images for review by trained medical practitioners) | Yes, as cleared by FDA. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided as the device is a display monitor, not an algorithm that processes medical images from a test set of patient data. The "test" for this device would involve engineering verification and validation against technical specifications and performance standards, likely using test patterns, calibrated measurement devices, and internal quality control procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. As a display device, there's no "ground truth" derived from patient cases in the way there would be for an AI algorithm. Ground truth for a display refers to its technical specifications and performance against industry standards, typically verified by engineers and quality control personnel.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical cases, which is not relevant for a display device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
This information is not applicable and not provided. An MRMC study assesses the diagnostic performance of human readers, typically with and without the assistance of an AI tool, across multiple cases. The Barco MIVD 1218 is a display device, not an AI tool, so such a study would not apply. Its effectiveness is in faithfully reproducing images, which can indirectly impact reader performance but isn't measured in this way.
6. If a Standalone (algorithm only without human-in-the-loop performance) study was done.
This information is not applicable and not provided. This refers to the performance of an AI algorithm independent of human interaction. The MIVD 1218 is a hardware device (a monitor) and does not perform algorithmic analysis.
7. The Type of Ground Truth Used
This information is not applicable in the clinical sense. For a display, the "ground truth" for its performance evaluation would be its adherence to defined technical specifications and industry standards (e.g., DICOM Part 14 for grayscale display function, luminance uniformity, contrast ratio). This would be established through a combination of engineering design specifications, calibrated measurement instruments, and standardized test patterns.
8. The Sample Size for the Training Set
This information is not applicable and not provided. A training set is used for machine learning algorithms. The MIVD 1218 is a hardware device and does not involve machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided. As there is no training set for a hardware display device, there is no ground truth to establish for it.
In summary: The provided document is a 510(k) summary for a medical display. The clearance process for such a device focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to relevant standards, rather than clinical performance studies involving patient data and expert diagnoses in the way AI/ML devices are evaluated.
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APR 2 0 2004
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510(K) SUMMARY
| Manufacturer: | Barco NV BarcoviewTheodoor Sevenslaan 1068500 KortrijkBelgium |
|---|---|
| Submitted By: | Ferguson MedicalConsultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Medical flat panel grayscale display, monitor,display and others |
| Proprietary Name: | MIVD 1218 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | MFCD 118 (K000291) |
| Device Description: | The MIVD 1218 is a diagnostic display |
| Intended Use: | The MIVD 1218 device is intended to be usedin displaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The MIVD 1218 device is a high resolutionmonitor with electronic capabilities forevaluation of high resolution medical images. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, with three lines above it. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Barco NV BarcoView c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111
Re: K033006
Trade/Device Name: MIVD 1218 18 Inch Grayscale Display Module Regulation Number: 21 CFR §892.2050 Regulation Namc: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2003 Received: January 26, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
. I a legally This letter will allow you to begin marketing your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaleries and the premarket notification. The FDA inding of substantial of arrants of 5-5
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), please
r the could be and on and of the first of the sumbers, becad on the requira If you desire specific advice for your device on our his may be number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion in the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. 1979, 2017 97 Other of Compliance at (501) 594-1057. FL00, percessor.97) you may obtain. Other geceeral by reference to prematical (21 of 1 x 1 x 1 x 1 x 1 x 8 x 4 x 4 x 4 x 4 x 4 x 4 x 4 x 1 x 1 x 1 x 1 x 1 x 1 information on your responsibilities under the Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-d (11 may Manufacturers, International and Consumer i Issionw.ida.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (If known): K033006
Device Name: MIVD 1218
Indications For Use:
The MIVD 1218 18 Inch Grayscale Display Module is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lymm
(Division Sign-Off)
Division of Reproductive, Abdominal, ane Padiological Devices 1550 5 11)(k) Number ______________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
§ 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).