(24 days)
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners.
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis. The DP-M3010 is consisted of the DP-M3010 display and the application software including Quality Control and Display Configuration Software. For the DP-M3010 display, 30-inch 10MP color LCD panel is used. The resolution is 10.5 megapixel (4096 x 2560). The DP-M3010 display has following two functions;
- . The hybrid view function: Monochrome compliant with the DICOM part 14 standard and color with non-DICOM gamma images are displayed on one screen at the same time.
- · The Contrast Enhancer function: Darkening the background of images.
The DP-M3010 has the built-in front sensor for monitoring display status. Using this front sensor allows for automatic correction of differences between the display characteristics that may change over time and the target image quality of the display. Also, The DP-M3010 has the ambient light correction function, namely correcting the luminance and gradation according to surrounding light by using the built-in ambient light sensor.
The Quality Control is software to be installed in a computer which controls the DP-M3010 display. The Quality Control software executes the calibration, runs tests compliant with various testing standards, creates test result reports, and monitors the DP-M3010 display conditions. The Display Configuration Software is used to perform the display settings. It is possible to save settings of the DP-M3010 Display on the computer. It is also possible to manually edit the areas for the hybrid view function.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the Canon DP-M3010 Mammography Color Display and its substantial equivalence to a predicate device, the RadiForce RX840-MG (K120451). The acceptance criteria are implicitly defined by the performance characteristics of the predicate device and the recommended tests for display accessories for full-field digital mammography systems.
| Feature | Acceptance Criteria (Implied by Predicate/Guidance) | Reported Device Performance (DP-M3010) |
|---|---|---|
| Display Performance / Specification | ||
| Screen technology | TFT Color LCD panel(IPS) | TFT Color LCD panel(IPS) |
| Screen surface | Anti-Glare (Predicate) | Anti-Reflection |
| Viewing angle (Horizontal, Vertical) | Horizontal:176°, Vertical:176° (CR > 10) (Predicate) | Horizontal:170°, Vertical:170° (CR > 50) |
| Active screen size | 817.1 x 430.9 mm (Predicate) | 645.12 x 403.2 mm |
| Resolution | 8MP (4,096 x 2,160) (Predicate) | 10.5 MP (4,096 x 2,560) |
| Aspect ratio | 17:9 (Predicate) | 16:10 |
| Pixel pitch | 0.1995 x 0.1995 mm (Predicate) | 0.1575 x 0.1575 mm |
| Maximum luminance | 700 cd/m² (Predicate) | 500 cd/m² |
| DICOM calibrated luminance | 500 cd/m² (Predicate) | 500 cd/m² |
| Contrast ratio | 1000:1 (Predicate) | 1000:1 |
| Backlighting | LED (Predicate) | LED |
| Gradation | 8 bit, 10 bit (Predicate) | 10 bit |
| Luminance non-uniformity compensation | Yes (Predicate) | Yes |
| Response speed | 25 ms (black-white-black) (Predicate) | 20 ms (black-white-black) |
| Video Signal Input | ||
| Input video signals | DVI-D(Dual Link) x2, DisplayPort x 2 (Predicate) | DisplayPort 1.1a x 4 |
| Scanning Frequency(V) | 29.5 - 61Hz (Predicate) | 59.922 - 60.317Hz |
| Dot Clock | DVI-D: 310MHz, DisplayPort: 290MHz (Predicate) | 174.25MHz x4 |
| Power Related Specifications | ||
| Power Requirements | AC 100 - 120V, 200 - 240V : 50/60Hz (Predicate) | AC 100 - 240V : 50/60Hz |
| Power Consumption Save Mode | 350W / 6W (Predicate) | 325W / 2W |
| Power Management | DVI DMPM, DisplayPort 1.1a (Predicate) | DisplayPort 1.1a |
| Miscellaneous Features/ Specifications | ||
| QC software | Yes (Predicate) | Yes |
| Sensors | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor (Predicate) | Backlight Sensor, Front Sensor, Ambient Light Sensor |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 2.0 (Predicate) | 1 upstream, 2 downstream / Rev. 2.0 |
| Dimensions w/o stand (W x H x D) | 896 x 527 x 157 mm (Predicate) | 707 x 465 x 106 mm |
| Contrast Enhancer (Darkening image Background) | No (Predicate) | Yes |
| Presence Sensor | Yes (Predicate) | No |
| Bench Tests (recommended by FDA Guidance) | All tests meet performance similar to or better than the predicate, demonstrating no new safety/effectiveness concerns. | Results showed display performance is equivalent to the RadiForce (K120451). |
| Electrical Safety | Compliance with IEC 60601-1 | Tests performed, results indicate no concern. |
| EMC | Compliance with IEC 60601-1-2 | Tests performed, results indicate no concern. |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the Canon DP-M3010 meets the acceptance criteria was a non-clinical bench test study comparing it to a legally marketed predicate device, the RadiForce RX840-MG (K120451).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical "sample size" in terms of patient cases or images, as this was a display device assessment. The "test set" implicitly refers to the physical DP-M3010 display unit itself and its components, upon which the bench tests were performed.
- Data Provenance: The tests were performed on the DP-M3010 model itself. The country of origin for the device is Japan (Canon Inc. - Hiratsuka Development Center). The study was prospective in the sense that specific tests were conducted on the newly developed device to assess its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study was a non-clinical bench test of a display device, not an AI or diagnostic algorithm requiring expert ground truth for interpretation of medical images. The "ground truth" for the display's performance was established by technical specifications and adherence to recognized standards for display quality.
4. Adjudication Method for the Test Set:
This information is not applicable as the study was a non-clinical bench test. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review, which is not the case here.
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:
No, an MRMC comparative effectiveness study was not done. This document pertains to a display device, not an AI or diagnostic algorithm that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the document describes a display device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance was established by:
- Technical specifications and performance characteristics of the legally marketed predicate device (RadiForce RX840-MG).
- Industry standards and guidelines for medical displays, specifically "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions," which recommended the specific bench tests performed (e.g., Luminance response, resolution, chromaticity, electrical safety, EMC).
8. The Sample Size for the Training Set:
This information is not applicable. There was no "training set" as this is a physical display device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as above.
§ 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).