The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Device Description

The DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ are flat panel hi-resolution LCD monitor systems for displaying medical images. The system consists of a LCD monitor and a highresolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.

AI/ML Overview

The provided document describes a 510(k) submission for a medical image display system. It is a pre-market notification to establish substantial equivalence to a predicate device, not a study evaluating device performance against acceptance criteria in the way a clinical trial for an AI diagnostic device would.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies is not applicable to this type of regulatory submission for a display system. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study.

Here's an attempt to extract relevant information and explain why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as performance metrics with numerical targets. For a display system like this, "acceptance criteria" likely refer to meeting performance specifications similar to the predicate device and relevant industry standards (e.g., DICOM, display luminance, contrast, resolution, uniformity). The document only states that the device contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device" and that the device will be manufactured "in accordance with voluntary and safety standards."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate device (CORONIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM, K013922)	Found to be substantially equivalent by FDA.
Compliance with voluntary and safety standards	Device will be manufactured in accordance with these standards.
Hazard analysis classifies potential hazards as Minor	Hazard analysis performed and classified potential hazards as Minor.
Functionality as a flat panel hi-resolution LCD monitor system for displaying medical images	System consists of LCD monitor and high-resolution graphic control board for image display.

2. Sample size used for the test set and the data provenance

Not Applicable. This document describes a display system, not an AI or diagnostic device that would undergo testing with a "test set" of medical images for diagnostic performance evaluation. The "data" being referenced would be the technical specifications and performance data of the display itself, demonstrating its capabilities as a medical image display.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. As above, there is no "test set" in the context of clinical ground truth for a display system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable.

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

Not Applicable. This device is a display system, not an AI or diagnostic tool. Therefore, no MRMC study, AI assistance comparison, or effect size is relevant or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware display system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For a display system, the "ground truth" would relate to its technical specifications (e.g., color accuracy, luminance uniformity, resolution, contrast ratios) as measured by calibrated instruments, rather than diagnostic "ground truth" on medical pathology. This information is not detailed in the summary.

8. The sample size for the training set

Not Applicable. This is a hardware display system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable.

Summary

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K03 263 8

SEP 1 1 2003

PLANAR

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

August 1, 2003

Submitter's Information: 21 CFR 807.92(a)(1)

Ms. Susan Hamann Planar Systems, Inc. 400 Fifth Ave. Waltham, MA 02451-8738 USA

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	DOME CXTM DIGITAL FLAT-PANEL DISPLAYSYSTEMTM, Models C3 ColorTM and C3 GrayTM
Common Name:	Picture Archiving Communications System
Classification:	892.2050
Name:	System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

Device ClassificationName	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number	892.2050
510(k) Number	K013922
Device Name	CORNIS 3MP MEDICAL FLAT PANEL DISPLAYSYSTEM
Applicant	BARCO NVP.O. BOX 12038LA JOLLA, CA 92039 2038
Product Code	LLZ
Decision Date	01/28/2002

Device Description: 21 CFR 807 92(a)(4)

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Image /page/1/Picture/0 description: The image shows the word "PLANAR" in a stylized, futuristic font. The letters are bold and angular, with sharp edges and diagonal lines giving it a modern and technological feel. The word appears to be a logo or brand name, possibly for a technology company or product.

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

The device is an imaqe display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ contain adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The Planar Systems, Inc., DOME CX™ DIGITAL FLAT-PANEL DISPLAY SYSTEM™. Models C3 Color"M and C3 Gray™ will be manufactured by in accordance with voluntary and safety standards.

The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

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Image /page/2/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2003

Planar Systems, Inc. % Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K032638

Dated: August 1, 2003 Received: August 27, 2003

Trade/Device Name: DOME CXTM Digital Flat-Panel Display System™ Models C3 Color™ and C3 GrayTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ

Dear Mr. Devine:

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 adultcration.

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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.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

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(Indications for Use Form)

510(k) Number: Ku3 2638

Device Name:

DOME CX™ DIGITAL FLAT-PANEL. DISPLAY SYSTEM™, Models C3 Color™ and C3 Gray™ from Planar Systems, Inc.

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Manyc Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032638

Regulation Number and Section

§ 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).