Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. These monitors are not intended for use in mammography.

Device Description

Monochrome LCD Monitors(TX-5M, TX-3M, TX-2M) are used to display images such as Xray, MRI images. These models have resolutions of: 2560x2048, 2048x1536, 1600x1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by SEQUEL IMAGING INC. These models are cortified to the EN60601-1 medical safety standard. The monitors use universal Power Supply compatible with AC100V~240V, 50/60Hz. The graphics card needed for the personal computer is the Real Vision & Matrox Scries. The monitors may be deployed in the portrait or the landscape position.

AI/ML Overview

This document describes a 510(k) submission for the "Truepix LCD Medical Display Monitor" (Models: TX-5M, TX-3M, TX-2M). It's important to note that this is a submission for a medical display monitor, not an AI or algorithm-based device. Therefore, many of the typical acceptance criteria and study aspects related to AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) don't apply directly here.

The "acceptance criteria" for a medical display monitor primarily revolve around meeting technical specifications and demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this typically involves technical testing and comparison against the predicate device's specifications.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the technical specifications of the predicate device (Lumimed MM20, MM30, and MM50 Monitors). The "reported device performance" are the specifications of the Truepix monitors, which the manufacturer asserts are substantially equivalent.

Acceptance Criteria (from Predicate Device: Lumimed MM20, MM30, and MM50)	Reported Device Performance (Truepix TX-2M, TX-3M, TX-5M)
Panel Size and Type: 21.3" /20.1" TFT monochrome LCD display	Truepix TX-2M: 21.3" TFT monochrome LCD display Truepix TX-3M: 21.3" TFT monochrome LCD display Truepix TX-5M: 20.1" TFT monochrome LCD display
Pixel Pitch: 0.270mm x 0.270mm, 0.2115mm x 0.2115mm, 0.156mm x 0.156mm	Truepix TX-2M: 0.270mm x 0.270mm Truepix TX-3M: 0.2115mm x 0.2115mm Truepix TX-5M: 0.156mm x 0.156mm
Native Resolutions (examples): 1200x1600(portrait), 1536x2048(portrait), 2048x2560 (portrait)	Truepix TX-2M: 1200x1600 (portrait) Truepix TX-3M: 1536x2048 (portrait) Truepix TX-5M: 2048x2560 (portrait)
Brightness (examples): 1000cd/m², 900cd/m², 850cd/m²	Truepix TX-2M: 1000cd/m² Truepix TX-3M: 800cd/m² Truepix TX-5M: 850cd/m²
Contrast Ratio (examples): 700:1, 700:1, 600:1	Truepix TX-2M: 700:1 Truepix TX-3M: 700:1 Truepix TX-5M: 600:1
Dot Clock (examples): 125MHz, 130MHz, 162MHz	Truepix TX-2M: 129MHz Truepix TX-3M: 130MHz Truepix TX-5M: 166.52MHz
Network Interface: USB (1 Up, 2 Downstream)	Truepix TX-2M, TX-3M, TX-5M: USB (1 Up, 4 Downstream)
Power: AC 100~240Volts/60Hz, DC 12V, 6.67A	Truepix TX-2M, TX-3M, TX-5M: AC 100~240Volts/60Hz, DC 12V, 6.67A
Luminance Calibration: Software (Optional), Photo-sensor (Optional)	Truepix TX-2M, TX-3M, TX-5M: Software (Optional), Photo-sensor (Optional)
Safety Certifications: EN60601-1 (Implicit for predicate as well, mentioned for new device)	Truepix TX-2M, TX-3M, TX-5M: Certified to the EN60601-1 medical safety standard

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 document. For a display monitor, performance testing would typically involve evaluating parameters like luminance, contrast, resolution, uniformity, color accuracy (for color displays, though this is monochrome), viewing angle, and stability over time. These tests are conducted on the physical device itself rather than on a "test set" of medical images or patient data. Therefore, concepts like data provenance, retrospective/prospective, and sample size of a test set of data are not applicable in the way they would be for an AI algorithm.

The testing would be on a sample of the manufactured monitors. The document states "Testing was performed according to internal company procedures," but does not detail the sample size (e.g., how many monitors were tested) or the methodology of this internal testing.

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 is not applicable as the device is a display monitor, not a diagnostic algorithm that interprets medical images. Therefore, there's no "ground truth" to be established by medical experts for a "test set" of images. The performance metrics are technical specifications of the display hardware.

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

This is not applicable for the same reasons as point 3.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on reader performance. This document is for a display monitor, which does not incorporate AI or directly assist in diagnostic interpretation beyond presenting the image.

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

This is not applicable as there is no algorithm being submitted for standalone performance evaluation.

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

This is not applicable as the device is a display monitor and does not involve diagnostic interpretations requiring such ground truth.

8. The sample size for the training set

This is not applicable as the device is not an AI algorithm requiring a training set.

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

This is not applicable for the same reasons as point 8.

Summary of the Study and Conclusion:

The "study" in this context is a comparison of technical specifications of the new device (Truepix LCD Medical Display Monitors) against a legally marketed predicate device (Lumimed MM20, MM30, and MM50 Monitors). The manufacturer performed "Testing... according to internal company procedures" to ensure the monitors met safety standards (EN60601-1) and performed comparably to the predicate. The conclusion drawn is that "In all material respects, the Truepix LCD Medical Display Monitors are substantially equivalent to the predicate device." This substantial equivalence, based on similar indications for use and comparable technological characteristics and performance specifications, allowed the device to receive 510(k) clearance from the FDA.

Summary

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Exhibit 2 NOV - 2 2007 510K Summary: K072532 DOOYANG SYSTEMS INC. SK Techno Bldg. 7th Floor 16-4, Sungsoo 1-Ga, 2-Dong, Sungdong-Ku, Seoul, 133-710 Korea TEL : 82-2-489-2612 FAX : 82-2-467-4915 Contact: Yun-Hwoi, Ku /Managing Director Date : October 30, 2007

1. Identification of Device :

Proprietary-Trade Name: "Truepix LCD Medical Display Monitor" (Models : TX-5M, TX-3M, TX-2M)

Classification Name: System, Image Processing, Radiological, Product Code: LLZ Common/Usual Name: Radiological Image Processing System, LCD Monitor

2. Equivalent Legally Marketed Devices:

Lumimed MM20, MM30 and MM50 Monitors, K052120

3. Indication for Use (Intended Use) :

4. Description of the Device

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KC72532
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Items	Lumimed MM20, MM30and MM50 Monitors,	New
		Truepix TX-2M	Truepix TX-3M	Truepix IX-5M
510(k) Numbers	K052120	New
Manufactures	Heeyoung Cl.	Dooynag Systems Inc.
Panel Size and Type	21.3" /20.1" TFTmonochrome LCD display	21.3" TFTmonochrome CDdisplay	21.3" TFTmonochrome LCDdisplay	20.1" IFTmonochrome LCDdisplay
Pixel Pitch	0.270mm x 0.270mm0.2115mm x 0.2115mm0.156mm x 0.156mm	0.270mm x 0.270mm	0.2115mm x0.2115mm	0.156mm x 0.156mm
Available CabinetColors	Black	Black	Black	Black
Native Resolutions	1200x1600(portrait)1600x1200(landscape)1536x2048 (portrait)2048x1536(landscape) or2048x2560 (portrait)2560x2048(landscape)	1200x1600 (portrait)1600x1200 (landscape)	1536x2048 (portrait)2048x1536 (landscape)	2048x2560 (portrait)2560x2048(landscape)
Brightness	1000cd/m2 900cd/m2850cd/m2	1000cd/m2	800cd/m2	850cd/m2
Contrast Ratio	700:1 700:1 600:1	700:1	700:1	600:1
Dot Clock	125MHz 130MHz 162MHz	129MHz	130MHz	166.52MHz
Network Interface	USB(1 Up, 2 Downstream)	USB(1 Up, 4 Downstream)	USB(1 Up, 4 Downstream)	USB(1 Up, 4 Downstream)
Active Display Size(HxV)	432(H) x 324(V)432(H) x 324(V)399(H) x 319(V)	433.152x324.864mm	433.152x324.864mm	399.36x319.49mm
Dimension (WxHxD)	472 x 495 x92472 x 495 x92438 x 458 x 98	505 w x 505 h x 81 d	505 w x 505 h x 81 d	445 w x 376 h x 90 d
Luminance Calibration	Software (Optional)Photo-sensor(Optional)	Software (Optional)Photo-sensor(Optional)	Software (Optional)Photo-sensor(Optional)	Software (Optional)Photo-sensor(Optional)
Power	AC 100~240Volts/60HzDC 12V,6,67A	AC 100~240Volts/60HzDC 12V,6,67A	AC 100~240Volts/60HzDC 12V,6,67A	AC100~240Volts/60HzDC 12V,6,67A

5. Safety and Effectiveness, comparison to predicate device

6. Testing Information and Conclusion

In all matcrial respects, the Truepix LCD Medical Display Monitors are substantially equivalent to the predicate device. Testing was performed according to internal company procedures and the monitors were safety certificd to International Standard.

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DEPARTMENT OF HEALTH & HUMAN SERVICES'

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

Doovang Systems, Inc. % Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K072532

Trade/Device Name: Truepix LCD Medical Display Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 4, 2007 Received: September 17, 2007

Dear Mr. Kamm:

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. Iisting 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 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.

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

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Enclosure

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Indications for Use

510(k) Number (if known): _ K072532___________________________________________________________________________________________________________________________________________

Device Name: "Truepix LCD Medical Display Monitor"

Indications For Use: Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. These monitors are not intended for use in mammography.

Prescription Use _ X (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)

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(Division Sign-Οπ)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072532

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).