20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Device Description

CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.

AI/ML Overview

The provided 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) is for a medical display device, not a diagnostic AI algorithm. Therefore, the questions regarding acceptance criteria and performance against a test set, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Medical display devices are typically evaluated based on technical specifications related to image quality (e.g., resolution, luminance, contrast, uniformity, color accuracy) and compliance with relevant industry standards (e.g., DICOM Part 14 for grayscale display function, display calibration standards). The "acceptance criteria" for such a device would generally involve meeting these technical specifications and demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.

The "study that proves the device meets the acceptance criteria" for a medical display would involve a series of technical tests and measurements to verify that the display performs according to its specifications and regulatory requirements.

However, based on the provided document, here's what information can be extracted or reasonably inferred:

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

The document does not provide a specific table of acceptance criteria with corresponding performance data in the format typically seen for algorithms. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device, CDL2009A (K061061), and meeting the general requirements for a Class II Picture Archiving and Communication System (PACS) component.

Acceptance Criteria (Inferred from Substantial Equivalence and Device Description):
- Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography." (Must match predicate and be appropriate for a medical display).
- Technological Characteristics: Multi-displaying function corresponding to resolutions from VGA 640 x 480 to UXGA 1600 x 1200, VESA standard display mode compliant. (Needs to be similar to predicate, or differences do not raise new questions of safety or effectiveness).
- Image Quality Parameters: (Not explicitly stated in the summary, but for a monitor, this would include luminance, contrast ratio, uniformity, resolution, color accuracy, and compliance with DICOM Part 14 for grayscale display, all of which would need to be tested and meet established standards for medical displays).
- Safety and EMC: (Compliance with relevant electrical safety and electromagnetic compatibility standards).
Reported Device Performance (Implicit/Stated):
- Intended Use: The device "is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography," which is accepted by the FDA.
- Technological Characteristics: "CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode."
- Substantial Equivalence: The FDA's 510(k) clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that any differences in performance from the predicate (CDL2009A) do not raise new concerns about safety or effectiveness. The key difference noted is "except for the LCD panel."

For the remaining points (2-9), these are entirely non-applicable to the provided document as it concerns a hardware display device, not a diagnostic algorithm that processes images and provides an output for interpretation.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" of medical images in the context of evaluating a display device.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth from experts is not established for hardware display evaluation in this manner.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for evaluating diagnostic performance with and without AI assistance for human readers, which is irrelevant for a display device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not a trained AI model.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K065200

510(k) SUMMARY

DEC - 7 2006

Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: haseqawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548

Date Prepared: October 17, 2006

Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204)
CDL2010A, CCL204, 2M Monitor/Display Common Name:
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: CDL2009A (K061061)
Device Description: CDL2010A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.
- Indended Use: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Substantial Equivalence: CDL2010A shares the same characteristics with our predicate device CDL2009A (K061061) except for the LCD panel.

TOTOKU ELECTRIC CO., LTD.

CDL2010A Premarket Notification

13/53 Page

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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized human figure with three wavy lines representing the body, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the figure. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN

DEC - 7 2006

Re: K063200

Trade/Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 20, 2006

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 Nossmetic 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.

Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. The word "Centennial" is written in a cursive font below the acronym. Three stars are arranged in a horizontal line below the word "Centennial". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health.

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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 (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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 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/cdrl/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

510(k) Number: Not Known

Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2010A (CCL204) 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Br. Hageman

Reproductive, Abdomir ical Devices 510(k) Nun

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).