Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a computer model for analyzing color measurement data to quantitatively evaluate the color performance of an endoscopy device.
Technical Description
The Color Performance Review (CPR) Tool for Endoscopy Devices is a software program written in Matlab for analyzing color performance testing data in endoscopy devices. The CPR tool accepts testing data and generates quantitative analyses for the user to compare color performance between devices. The input testing data include the measurement data of a standard color test target from the device output as well as the ground truth of the test target.
The tool provides the following analyses:
- Visual simulation of the test target and sample scenes
- Absolute color errors in comparison with the ground truth
- Preservation of the patch order in lightness, hue, and chroma
- Preservation of color contrast between patches
Intended Purpose
The Color Performance Review Tool for Endoscopy Devices is intended for analyzing color measurement data to quantitatively evaluate the color performance of an endoscopy device. The tool converts acquired raw color performance measurement data into the human perceptual domain such that color performance concerns can be readily identified.
Intended users are device developers, FDA technical reviewers (color performance consultants), and third-party testing labs.
Testing
The quantitative colorimetrical calculation has been validated by using different implementations of the same formulas as well as comparing with external data and open-source code in the public domain. The quantitative colorimetrical order has been validated manually. The visualization has been tested and confirmed.
Limitations
This tool deals with data analysis only and is reliant on availability of an accurate reference standard. The ground truth of the test target should be obtained in the acquisition stage under the same illumination conditions.
The user needs basic colorimetry knowledge to use the tool and interpret the results.
The tool was designed for the white light mode. It is not suitable for modes using non-white narrow-band illumination.
Supporting Documentation
The documentation is embedded in the tool as a Matlab Live Script available in GitHubExternal Link Disclaimer. Step-by-step instructions in a .readme fileExternal Link Disclaimer are also available on GitHub.