The 5MP (Mammo) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Device Description

The 5MP (Mammo) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical and mammography images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.

AI/ML Overview

The provided text is a 510(k) summary for the WIDE Corporation's 5MP (Mammo) LCD Monitor System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or clinical effectiveness.

The device described is a medical monitor system, not an AI-powered diagnostic tool. Therefore, many of the requested criteria (such as sample size for test sets, ground truth establishment, MRMC studies, standalone algorithm performance, and training set information) are not applicable or present in this type of document for a monitor.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence in terms of technological characteristics and safety, not on specific performance criteria related to diagnostic accuracy (which would be relevant for an AI-powered device). The monitor's performance would be assessed against technical display standards, not clinical outcome metrics.

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

Sample size: Not applicable/Not provided. This document describes a monitor, not an algorithm tested with a dataset of medical images.
Data provenance: Not applicable/Not provided.

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

Not applicable/Not provided. Ground truth is not established for a monitor in the same way it would be for a diagnostic algorithm.

4. Adjudication method for the test set:

Not applicable/Not provided.

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/Not provided. This is a monitor, not an AI system.

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

Not applicable/Not provided. This is a monitor, not an algorithm.

7. The type of ground truth used:

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is a monitor, not a machine learning model.

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

Not applicable/Not provided.

Summary of what the document does provide:

Device: 5MP (Mammo) LCD Monitor System™
Intended Use: Displaying and viewing medical digital images for review and analysis by trained medical practitioners, specifically for digital mammography applications.
Predicate Device: CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K041508)
Regulatory Focus: Substantial equivalence regarding technological characteristics, safety, and compliance with voluntary and safety standards (e.g., UL, IEC, FCC, CE).
Safety Assessment: Potential hazards classified as Minor.
Conclusion: The FDA determined the device is substantially equivalent to the predicate device.

To answer your request comprehensively, you would need a different type of document, such as a clinical validation report, if the device were software or an AI algorithm, rather than a monitor.

Summary

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Image /page/0/Picture/1 description: The image shows the word "WIDE" in large, bold, white letters against a black background. Above the word "WIDE" is the number "2052312" written in black ink. Below the word "WIDE" is some text that is too small to read.

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 22, 2004

Submitter's Information: 21 CFR 807.92(a)(1) WIDE Corporation Mr. YS Lim, President & CEO 576-5 Miwon-Ri, Miwon-Myun, Cheongwon-Gun Chung, Korea 363-874 Phone: 82 43 297-0520 82 43 297-0521 Fax:

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) 5MP (Mammo) LCD Monitor System™ Trade Name: Common Name: Picture Archiving Communications System Device Classification: 892.2050 System, Image Processing Name:

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

Device Classification Name	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number	892.2050
510(k) Number	K041508
Device Name	CORNIS 5MP MEDICAL FLAT PANEL DISPLAYSYSTEM
Applicant	BARCO NV
Product Code	LLZ
Decision Date	8/27/2004

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

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Image /page/1/Picture/0 description: The image shows the word "WIDE" in large, bold, white letters against a black rectangular background. Below the rectangle, there is some smaller text that is difficult to read due to its size and the image quality. The overall design appears to be a logo or branding element, with the focus on the prominent "WIDE" text.

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

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

The device is an image 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 5MP (Mammo) LCD Monitor System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The 5MP (Mammo) LCD Monitor System™ will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards: Safety / lmmunity UL2601-1/EN60601-1 210 Edition, Medical Electrical Equipment, / IEC601-1-2 200 Edition EMC Requirements, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B digital device, pursuant to Part 15.

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 the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WIDE Corporation % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210 Re: K052312 Trade/Device Name: 5MP (Mammo) LCD Monitor System™ by WIDE Corporation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2005 Received: August 26, 2005

Dear Mr. Alletto:

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 (Premarket 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 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 docs 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 his letter wit anow your o organ interes of your device of your device to a legally marketed predication: " Price PDF milling star 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 If you desire specific active for your cerrethe following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.77). It ou may obtain only general missistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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)

K052312 510(k) Number:

Device Name:

5MP (Mammo) LCD Monitor System™ by WIDE Corporation

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Syrom

and Ra 510k) N

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).