(29 days)
The Dome® GX4MP Color Monitor is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
The Dome® GX4MP Color Monitor is a 30-inch 4 megapixel Color flat-panel AMLCD-TFT monitor for use with IBM PC or PC compatible computers for widescreen imaging. The combination of high resolution and high contrast ratio allow the viewing of color and grayscale images simultaneously. Bezel-free framing of 4 megapixels of data is presented in a landscape resolution of 2560 x 1600 pixels. Gamma correction is achieved on this true color display from a palette of 1,786 near-gray values. The integrated Dome RightLight Controller monitors and stabilizes backlight luminance. The display unit includes a PCI Express graphics board to support the required duallink connectivity for the display.
The provided text is a 510(k) summary for a medical display monitor, the Dome® GX4MP Color Monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study for acceptance criteria of an AI/algorithm-based device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document, as it pertains to the regulatory submission for a display monitor, not an AI or algorithm.
However, I can extract the following relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a performance study for an algorithm. Instead, it presents a comparison of technological characteristics between the new device (Dome GX4MP) and a predicate device (Dome E4c) to demonstrate substantial equivalence. The "performance" in this context refers to the specified features of the device:
| Characteristic | Prior Approved Device (Dome E4c) | New Device (Dome GX4MP) |
|---|---|---|
| Product Model Name | Dome E4c | Dome GX4MP |
| Intended Use | To be used in displaying and viewing medical images for review and analysis by trained medical practitioners. | Unchanged (Same as predicate) |
| Display Characteristics | 4MP 2560x1600 pixel display, 16 million colors, 1786 shades of near-gray values, Factory DICOM calibrated, 370 cd/m2 IPS technology, 700:1 contrast ratio, 170 degree viewing angle | Unchanged (Same as predicate) |
| Power Supply | External IEC/EN 60601-1 power supply. | Internal IEC/EN 60950 power supply. |
| Location for Use | Radiology reading room. Not intended or marketed for near-patient use. | Unchanged (Same as predicate) |
| Enclosure | Laser-cut sheet metal back. Metal and glass bezel. | Molded plastic back and bezel. Integrated USB hub. |
The acceptance criterion, implicitly, is that the new device's key performance characteristics (display resolution, color depth, DICOM calibration, luminance, contrast, viewing angle, and intended use) are "unchanged" or demonstrably equivalent to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document because it is for a display monitor, not an algorithm that processes data or images.
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 information is not applicable and not provided as there is no "test set" or "ground truth" in the context of an algorithmic performance study for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 information is not applicable and not provided. MRMC studies are used for evaluating the impact of AI on human reader performance, which is not relevant for a display monitor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a display monitor, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided.
8. The sample size for the training set
This information is not applicable and not provided. The device is hardware (a display monitor), not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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K120709
APR - 6 2012
510(K) SUMMARY
NDS Surgical Imaging, LLC 5750 Hellyer Avenue San Jose: CA 95138 USA '
Jim Leng Regulatory Engineer/NDS Surgical Imaging, LLC
February 15, 2012
408-776-0085 Tel: 408-776-9878 Fax:
Picture Archiving Communication System
System, Image Processing, Radiological
The Dome® GX4MP Color Monitor
21 CFR 892.2050
LLZ
Predicate K060136 PLANAR DOME DIGITAL FLATPANEL DISPLAY SYSTEM, Model E4c
The Dome® GX4MP Color Monitor is a 30-inch 4 megapixel Color flat-panel AMLCD-TFT monitor for use with IBM PC or PC compatible computers for widescreen imaging. The combination of high resolution and high contrast ratio allow the viewing of color and grayscale images simultaneously.
The Dome® GX4MP Color Monitor is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
Bezel-free framing of 4 megapixels of data is presented in a landscape resolution of 2560 x 1600 pixels. Gamma correction is achieved on this true color display from a palette of 1786 near-gray values.
B. Submitted By:
A. Manufacturer:
င်. Date of Preparation:
D. Contact Information:
E. Classification:
F. Common Name: .
G. Proprietary Name:
H. Classification Number: バン
l Product Code:
J. Substantial Equivalence:
K. Device Description:
Intended Use:
M. Technological Characteristics:
San Jose, CA 95138 www.ndssi.com
Image /page/0/Picture/29 description: The image contains the word "GRADIANCE" in bold, black letters. The letters are stacked vertically, with the "G" at the top and the "E" at the bottom. The word appears to be a logo or brand name. The image is simple and straightforward, with a focus on the text.
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Image /page/1/Picture/0 description: The image shows the logo for NDS Surgical Imaging. The logo features a stylized graphic to the left of the text "NDS". Below the text is the phrase "SURGICAL - IMAGING" in a smaller font. The graphic consists of a grid of squares that appear to be receding into the distance, creating a sense of depth.
The integrated Dome RightLight Controller monitors and stabilizes backlight luminance. The display unit includes a PCI Express graphics board to support the required duallink connectivity for the display.
Substantial Equivalence Comparison Chart
| Prior approved device. | New device. | |
|---|---|---|
| Product Model Name | Dome E4c | Dome GX4MP |
| Intended Use | To be used in displaying andviewing medical images forreview and analysis by trainedmedical practitioners. | Unchanged. |
| Display characteristics | 4MP 2560x1600 pixel display16 million colors1786 shades of near-gray valuesFactory DICOM calibrated370 cd/m2 IPS technology700:1 contrast ratio170 degree viewing angle | Unchanged. |
| Power Supply | External IEC/EN 60601-1 powersupply. | Internal IEC/EN 60950 powersupply: |
| Location for Use | Radiology reading room. Notintended or marketed for near-patient use. | Unchanged. |
| Enclosure | Laser-cut sheet metal back.Metal and glass bezel. | Molded plastic back and bezel.Integrated USB hub. |
Avenue = San J .ndssi.com
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jim Leng Regulatory Engineer NDS Surgical Imaging, LLC 5750 Hellyer Avenue SAN JOSE CA 95138
Re: K120709
Trade/Device Name: The Dome® GX4MP Color Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 28, 2012 Received: March 8, 2012
Dear Mr. Leng:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
APR - 6 2012
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number
(If known)
The Dome® GX4MP Color Monitor Device Name: The Dome® GX4MP Color Monitor is intended to be used in displaying
Color Monitor is a consisted and enalysis by trained medical Indications for Use The Dome® GX4MP Color Monkor is interior.
and viewing medical images for review and analysis by trained medical practitioners.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitre Diagnostic Device Evaluation and
In Vitro Diagriostic Device Evaluation and Safety Office office office office office office office office office office office office office office office office office office office office office office office office office
Prescription Use _ (Per 21 CFR 801.109) OR Over-The-Counter Use_
§ 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).