(47 days)
20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
CDL2112A (CCL350i) (DV3MC-HB) is a 20.8-inch Color LCD Monitor that supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
This document describes a 510(k) submission for a medical display monitor, not an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like human reader improvement with AI assistance, training set details, and ground truth establishment for training) is not applicable or cannot be extracted from the provided text.
The document is a 510(k) summary and the FDA's clearance letter for the "20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB)" from TOTOKU ELECTRIC CO., LTD. This is a display device intended for medical imaging applications in conjunction with PACS, not a software algorithm that performs diagnostic analysis.
Here's what can be gathered, addressing the spirit of the request where applicable to a medical display:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way one would for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). For a medical display, acceptance criteria would typically relate to its technical specifications and performance characteristics, and compliance with relevant standards.
The document mentions:
- Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB)
- Resolution: QXGA (2048 x 1536) for both landscape and portrait display.
- Intended Use: To be used in conjunction with picture archiving communication systems (PACS) for medical imaging applications. Not meant to be used for digital mammography.
- Substantial Equivalence: The device has "almost the same characteristics" as the predicate device CDL2114A (K043430), "except for the molds, the LCD panel, and the front sensor". This implies that the performance characteristics of the predicate device serve as the de facto acceptance criteria. The specific performance metrics of the predicate device are not detailed here but would have been assessed during its own clearance process.
Summary Table (based on available information for a display device):
| Acceptance Criterion (Implied for a Medical Display) | Reported Device Performance |
|---|---|
| Display Size | 20.8-inch (53cm) |
| Display Type | Color LCD Monitor |
| Supported Signal | DVI video signal |
| Resolution | QXGA (2048 x 1536) for both landscape and portrait display |
| Intended Use | To be used with PACS for medical imaging applications (excluding digital mammography) |
| Substantial Equivalence to Predicate | Determined by FDA as substantially equivalent to CDL2114A (K043430), with minor differences in molds, LCD panel, and front sensor. This implies functional and performance equivalence to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a hardware device (monitor), not a software algorithm tested on medical image data. There is no "test set" of medical images for software performance evaluation mentioned.
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)
Not applicable. As above, this pertains to a monitor, not an algorithm requiring ground truth derived from expert interpretation of medical images.
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 is a display device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth as typically understood for diagnostic AI algorithms is not relevant for a medical display device's clearance. The ground truth for a display would relate to its ability to accurately render images according to technical specifications and industry standards.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the word "TOTOKU" in bold, black letters. The letters are large and spaced closely together. A double line is present underneath the word.
510(k) SUMMARY
- TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Nagano 386-0192 Japan
Mikio Hasegawa, General Manager Contact Person: Email: hasegawam@totoku.co.jp +81.268.34.5469 Tel: Fax: +81.268.34.5565
Date Prepared: March 7, 2005
-
20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) Device Name:
CDL2112A, CCL350i, DV3MC-HB, 3M Monitor/Display Common Name: -
Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: CDL2114A (K043430) -
CDL2112A (CCL350i) (DV3MC-HB) is a 20.8-inch Color LCD Monitor that Device Description: supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
- 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to Intended Use: be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
-
Substantial Equivalence: CDL2112A (CCL350i) (DV3MC-HB) has almost the same characteristics as TOTOKU's predicate device CDL2114A (K043430) except for the molds, the LCD panel, and the front sensor, which has been newly placed.
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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boullevard Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano, 386-0192 JAPAN
Re: K050619 Trade/Device Name: 20.8-inch (53cm) Color Monitor CDL2112A (CCL350i) (DV3MC-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 7, 2005 Received: March 10, 2005
Dear Ms. 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 (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 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 6 2005
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter with and on. The FDA finding of substantial equivalence of your device to a legally promatics notified in " 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.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 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 (301) 443-6597 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
Enclosure
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INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB). Indications for use:
20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use
AND/OR
(Part 21 CFR 801 Subpart D)
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)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K050619
510(k) Number
§ 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).