(53 days)
CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
CW60N LCD Monitor is intended to display high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying and reviewing of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
EzCal is packed with the display.
Here's an analysis of the provided text regarding the CW60N LCD Monitor, focusing on the acceptance criteria and the study proving compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results directly tied to the "acceptance criteria" language. Instead, it lists a series of bench tests performed and then concludes that the device "meets the acceptance criteria." The performance evaluation is implied through the successful completion of these tests as per the FDA guidance document.
Below is an attempt to create a table based on the information provided, inferring acceptance criteria from the tests performed and the statement about meeting them.
| Acceptance Criteria Category (Inferred from Test Item) | Reported Device Performance (Inferred from "meets acceptance criteria") |
|---|---|
| Pixel Defects & Artifacts | Successfully passed (no unacceptable pixel defects or artifacts) |
| Luminance | Successfully passed (met specified luminance requirements) |
| Reflection | Successfully passed (met specified reflection requirements) |
| Luminance Uniformity | Successfully passed (met specified luminance uniformity requirements) |
| Veiling Glare | Successfully passed (met specified veiling glare requirements) |
| Color Uniformity | Successfully passed (met specified color uniformity requirements) |
| Luminance Response | Successfully passed (met specified luminance response requirements) |
| Luminance at 30° and 45° (horizontal & vertical) | Successfully passed (met specified luminance at angles requirements) |
| Temporal Performance | Successfully passed (met specified temporal performance requirements) |
| Color Tracking | Successfully passed (met specified color tracking requirements) |
| Gray Tracking | Successfully passed (met specified gray tracking requirements) |
| MTF (Modulation Transfer Function) | Successfully passed (met specified MTF requirements) |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" performed on "the CW60N," implying that at least one physical unit of the device was tested. It does not provide the number of units or repeated measurements.
- Data Provenance: The tests were performed following the instructions in the FDA's "Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff" (October 2, 2017). This indicates the tests were conducted specifically for regulatory submission, likely prospective in nature, as they were performed on the CW60N device. There is no information regarding the country of origin of the data beyond the manufacturer being in the Republic of Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The "ground truth" for the performance tests of a medical display monitor typically refers to established technical specifications and industry standards (like DICOM Part 14 GSDF or the FDA guidance document itself) rather than expert human interpretation of medical images. The tests evaluate the physical display characteristics.
- Qualifications of Experts: Not applicable. The tests are objective measurements against technical standards. While engineers or technicians with specific expertise in display calibration and testing would perform these, their qualifications in terms of medical image interpretation (e.g., radiologist experience) are not relevant here.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As mentioned above, the tests are objective measurements against established technical specifications. There is no subjective human adjudication process described or required for these types of device performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:
- No, an MRMC comparative effectiveness study was not done.
- This device is an LCD monitor for displaying medical images, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- No, a standalone (algorithm only) performance study was not done.
- This device is a hardware display monitor. Its performance is evaluated based on its physical characteristics and ability to accurately render images according to standards, not as a standalone algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance is based on technical specifications, industry standards (e.g., DICOM Part 14 GSDF), and regulatory guidance documents (FDA's "Display Devices for Diagnostic Radiology"). These documents define the expected objective performance characteristics of a medical display monitor.
8. The Sample Size for the Training Set:
- Not applicable. This device is a hardware monitor, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a hardware display monitor.
§ 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).