This 510(k) summary is for a medical display device, not an AI-powered diagnostic tool. Therefore, the typical acceptance criteria and study designs that would be applicable to an AI device (focusing on sensitivity, specificity, clinical outcome, etc.) are not present in this document.

The "acceptance criteria" for this device are its compliance with various medical safety and EMC standards, and its substantial equivalence to a predicate device. The "study" proving it meets these criteria is essentially a comparison of its specifications to those of the predicate device and a statement of compliance with relevant regulatory standards.

Here's the information as requested, adapted to what is available in the provided text for a medical display:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard (as implied or stated)	Reported Device Performance/Compliance
Medical Safety	UL2601-1	Complies (CDL Series)
	CSA No. 601-1 (CSA C22.2 No. 601.1 for CDL)	Complies (CDL Series)
	MDD/CE (EN60601-1, IEC60601-1)	Complies (CDL Series)
Electromagnetic Compatibility (EMC)	MDD/CE (EN60601-1-2), IEC60601-1-2	Complies (CDL Series)
	FCC-B (FCC Class B for CDL)	Complies (CDL Series)
	DOC-B	Complies (CDL Series)
	BSMI	Complies (CDL Series)
Substantial Equivalence	Similar intended use to predicate device	Intended use: "viewing digital medical images." This is identical to the implicit intended use of a diagnostic display.
	Similar technological characteristics to predicate device	Specifications (display area, input signal, maximum display pixels, scanning frequency, maximum image clock, maximum brightness, power supply) are compared to the predicate ME311L. Differences are noted but deemed equivalent for the stated use.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable to this type of device submission. This document describes a medical display, which is a hardware component. Its performance is assessed through engineering specifications and compliance with standards, not through clinical trials with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no "ground truth" in the clinical sense for a medical display. Its performance is objectively measured against technical specifications and regulatory standards by engineers and compliance bodies.

4. Adjudication Method for the Test Set

Not applicable. Performance is based on technical measurements and compliance checks, not expert adjudication of clinical findings.

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 is not an AI device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable. The "ground truth" for a medical display is its adherence to specified technical standards and performance metrics, measured by test equipment, not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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APR 2 5 2003

510(k) Summary

as required by 807.92

K030276

Company Identification 1.

Totoku Electric Co., Ltd. 300 Oya, Ueda-shi, Nagano-ken, 386-0192, JAPAN Tel: 011-81-268-34-5484 Fax: 011-82-268-34-5565

Official Correspondent 2.

Mikio Hasegawa (Mr.) General Manager Product Development Dept.

Date of Submission 3.

Jan. 24, 2003

Device Trade Name 4.

Flat Panel Displays, CDL Series

Common Name న్.

Monitor, display, workstation, and others

Classification 6.

Medical displays are classified as Class I or II per 21 CFR 890.2050

Predicate Device 7.

Totoku ME311L 3 Mega Pixel Diagnostic Display, manufactured by Totoku Electric Co., Ltd. (K012099). Comparison of the principle characteristics of the device which is pertinent to clinical performance is shown in Appendix 1.

Description of Device 8.

CDL Series Medical Displays are displays for medical use.

Intended Use 9.

CDL Series Medical Displays are intended for use in viewing digital medical images.

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10. Explanation of CDL Series

CDL Series consists of color LCD displays listed below. Model No. CDL1811A Model No. CDL1813A

Comparison of specifications are shown in Appendix 2.

11. Compliance

All CDL Series listed above comply with the following standards. Medical Safety: UL2601-1, CSA No. 601-1, MDD/CE (EN60601-1, IEC60601-1)

MDD/CE (EN60601-1-2), IEC60601-1-2, and FCC-B EMC:

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Specification Comparison Chart with Predicate Device Appendix 1

Item	ME311L	CDL1811A
510(k) Number	K012099	Not known
Display area	Horizontal:423.9mm, Vertical:318.0mm	Horizontal: 359.0mm, Vertical: 287.2mm
Input signal	GVIF video signal10214-1210VE (3M:MDR14P)	D-SUB (analog), DVI-D (digital)
Maximum display pixels	Portrait: 1536 dots X 2048 lineLandscape: 2048 dots X 1536 line	1280 X 1024 dots
Scanning frequency	Horizontal:93KHz, Vertical:60Hz	Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz
Maximum image clock	65MHz	135MHz
Maxmum brightness	600cd/m2	240cd/m2
Brightness calibration	Software(option)Photosensor(option item)-DTP92(X-Lite)
Serial communication connector	D-sub 9P x 2	15P Mini D-SUB, 24P DVI-D, 4P DC input terminal9p Mini D-SUB serial (RS232C)
Agency standards	Medical safety:UL2601-1,CSA No.601-1EN60601-1MDD/CE:(EN60601-1, EN60601-1-2)	Medical safety: UL2601-1,CSA CSA C22.2No.601.1(EN60601-1), FCC Class B, DOC-B, BSMI
Dimensions and weight(incl. Tilt and swivel)	Net, 486x480x250mm(W x H x D) (landscape)11kg380x533x250mm(W x H x D) (portrait)Packed, 733x642x363mm(W x H x D) 17kg	Net: 432x353x68.6mm(W x H x D) (landscape) 6.9kgPacked: 485x600x280mm(W x H x D) 12kg
Power supply	100-240V AC, 50/60Hz	100-250V AC, 50/60Hz

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Appendix 2 Specification Comparison Chart of the Applied Models

Item	CDL1811A	CDL1813A
510(k) Number	Not known	Not known
Display area	Horizontal: 359.0mm, Vertical: 287.2mm	Horizontal: 359.0mm, Vertical: 287.2mm
Input signal	D-SUB (analog), DVI-D (digital)	D-SUB (analog), DVI-D (digital)
Maximum display pixels	1280 X 1024 dots	1280 X 1024 dots
Scanning frequency	Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz	Horizontal: 31K - 80KHz, Vertical: 55 - 85Hz
Maximum image clock	135MHz	135MHz
Maxmum brightness	240cd/m2	240cd/m2
Brightness calibration	-	-
Serial communication connector	15P Mini D-SUB, 24P DVI-D, 4P DC input terminal9p Mini D-SUB serial (RS232C)	15P Mini D-SUB, 24P DVI-D, 4P DC input terminal9p Mini D-SUB serial (RS232C)
Agency standards	Medical safety: UL2601-1,CSA CSA C22.2No.601.1(EN60601-1), FCC Class B, DOC-B, BSMI	Medical safety: UL2601-1,CSA CSA C22.2No.601.1(EN60601-1), FCC Class B, DOC-B, BSMI
Dimensions and weight	Net: 432x353x68.6mm(W x H x D) (landscape) 6.9kgPacked: 485x600x280mm(W x H x D) 12kg	Net: 432x353x68.6mm(W x H x D) (landscape) 6.9kgPacked: 485x600x280mm(W x H x D) 12kg
Power supply	100-250V AC, 50/60Hz	100-250V AC, 50/60Hz

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Product Development Dept., MM Company 300 Oya. Ueda-shi Nagano 286-0192 JAPAN

Re: K030276 Trade/Device Name: Flat Panel Display, CDL Series Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 24, 2003 Received: January 27, 2003

Dear Mr. Hasegawa:

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.

APR 2 5 2003

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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 vours.

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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510(k) Number (If known): Not known KO30

Device Name: Flat Panel Displays, CDL Series

Indications for Use:

CDL Series Medical Displays are intended for use in viewing digital medical images.

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

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030276

Prescription Use the markdown representing the content of the image is:Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030276

Prescription Use OR Over-The-Counter Use
(Optional Format 1-2-96)

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).