(10 days)
3MP Mcdical Monochrome Reference Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
The provided document is a 510(k) premarket notification for a medical display, not a study evaluating a device's performance against acceptance criteria for an AI algorithm. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for AI development and evaluation is not present in this document.
The document primarily focuses on establishing "substantial equivalence" of the Medical Display, MDM2130-3NC, to a predicate device (MDM1900-1NR) based on similar intended use and characteristics. It does not contain information about a clinical trial or performance study typical for AI/CAD devices.
Here's an analysis of the provided information, noting what is present and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document is for a medical display device, not an AI algorithm. It does not include specific performance metrics (like sensitivity, specificity, AUC) or acceptance criteria typically associated with AI device evaluation. The "performance" assessment here is a declaration of substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Provided. No test set data or provenance information is included as this is not a performance study for an AI algorithm.
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 Provided. Ground truth establishment is not relevant for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Provided. Adjudication methods for test sets are not relevant for this type of device submission.
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 Provided. No MRMC study was conducted or mentioned, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Provided. This is not an algorithm; it's a display monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Provided. Ground truth generation is not applicable to a medical display device.
8. The sample size for the training set
- Not Provided. No training set is mentioned or applicable.
9. How the ground truth for the training set was established
- Not Provided. No training set or ground truth establishment relevant to AI is mentioned.
Summary of what is available in the document:
- Device Name: Medical Display, MDM2130-3NC
- Intended Use: To display images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Explicitly stated as "not suitable for a digital mammography system."
- Predicate Device: Medical Display - MDM1900-1NR (K061303)
- Conclusion: The device is substantially equivalent to the predicate device, sharing similar characteristics with minor differences that "do not raise new questions of safety and effectiveness."
- Regulatory Classification: Class II, 21 CFR 892.2050 (System, Image Processing, Radiological).
This document serves as a regulatory submission for a display device, focusing on its equivalence to an already approved device rather than clinical performance testing against specific diagnostic criteria.
{0}------------------------------------------------
510(K) Summary of Safety and Effectiveness
As required by 807.92
NOV - 9 2006
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Phil Chen CHILIN TECHNOLOGY CO., LTD. No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 = 4751
2. DATE SUMMARY PREPARED
28 June 2006
3. DEVICE NAME
Trade Name: Medical Display, MDM2130-3NC Common Name: Monochrome LCD Monitor, Monochrome Diagnostic Display, etc.
Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)
4. PREDICATE DEVICE
Medical Display - MDM1900-1NR 19" Monochrome LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061303).
5. DEVICE DESCRIPTION
Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
6. DEVICE OF INTEND USE
Medical Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system
{1}------------------------------------------------
CONCLUSION 7.
Medical Display, MDM2130-3NC has the same intended use as the predicate device MDM1900-1NR, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to MDM1900-1NR by CHILIN TECHNOLOGY CO., LTD. (K061303).
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Chi Lin Technology Co., LTD. % Mr. Marc M. Mouser Senior Project Engineer, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
NOV - 9 2006
Re: K063266
Trade/Device Name: Medical Display, MDM2130-3NC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 27, 2006 Received: October 30, 2006
Dear Mr. Mouser:
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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".
ad Promoting Public 9
{3}------------------------------------------------
Page 2 -
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/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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K063264
Device Name: Medical Display, MDM2130-3NC
Indications For User 3MP Mcdical Monochrome Reference Display, MDM2130-3NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broadon
(Division Sign-Off) Division of Reproducti and Radiological Device 510(k) Numbe
§ 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).