Evaluation Challenges for the Application of Extended Reality Devices in Medicine.

Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices' safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration's public workshop, "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine" and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases.

Technical Note: Gray tracking in medical color displays-A report of Task Group 196.

PURPOSE: The authors discuss measurement methods and instrumentation useful for the characterization of the gray tracking performance of medical color monitors for diagnostic applications. The authors define gray tracking as the variability in the chromaticity of the gray levels in a color monitor. METHODS: The authors present data regarding the capability of color measurement instruments with respect to their abilities to measure a target white point corresponding to the CIE Standard Illuminant D65 at different luminance values within the grayscale palette of a medical display. The authors then discuss evidence of significant differences in performance among color measurement instruments currently available for medical physicists to perform calibrations and image quality checks for the consistent representation of color in medical displays. In addition, the authors introduce two metrics for quantifying grayscale chromaticity consistency of gray tracking. RESULTS: The authors' findings show that there is an order of magnitude difference in the accuracy of field and reference instruments. The gray tracking metrics quantify how close the grayscale chromaticity is to the chromaticity of the full white point (equal amounts of red, green, and blue at maximum level) or to consecutive levels (equal values for red, green, and blue), with a lower value representing an improved grayscale tracking performance. An illustrative example of how to calculate and report the gray tracking performance according to the Task Group definitions is provided. CONCLUSIONS: The authors' proposed methodology for characterizing the grayscale degradation in chromaticity for color monitors that can be used to establish standards and procedures aiding in the quality control testing of color displays and color measurement instrumentation.

Consistency and standardization of color in medical imaging: a consensus report.

This article summarizes the consensus reached at the Summit on Color in Medical Imaging held at the Food and Drug Administration (FDA) on May 8-9, 2013, co-sponsored by the FDA and ICC (International Color Consortium). The purpose of the meeting was to gather information on how color is currently handled by medical imaging systems to identify areas where there is a need for improvement, to define objective requirements, and to facilitate consensus development of best practices. Participants were asked to identify areas of concern and unmet needs. This summary documents the topics that were discussed at the meeting and recommendations that were made by the participants. Key areas identified where improvements in color would provide immediate tangible benefits were those of digital microscopy, telemedicine, medical photography (particularly ophthalmic and dental photography), and display calibration. Work in these and other related areas has been started within several professional groups, including the creation of the ICC Medical Imaging Working Group.

Color error in the digital camera image capture process.

The color error in images taken by digital cameras is evaluated with respect to its sensitivity to the image capture conditions. A parametric study was conducted to investigate the dependence of image color error on camera technology, illumination spectra, and lighting uniformity. The measurement conditions were selected to simulate the variation that might be expected in typical telemedicine situations. Substantial color errors were observed, depending on the measurement conditions. Several image post-processing methods were also investigated for their effectiveness in reducing the color errors. The results of this study quantify the level of color error that may occur in the digital camera image capture process, and provide guidance for improving the color accuracy through appropriate changes in that process and in post-processing.