Evaluation of Two DigitalWound Area Measurement Methods Using a Non-Randomized, Single-Center, Controlled Clinical Trial

Abstract

A prospective, single-center, non-randomized, pre-marketing clinical investigation was conducted with a single group of subjects to collect skin lesion images. These images were subsequently utilized to compare the results obtained from a traditional method of wound size measurement with two novel methods developed using Machine Learning (ML) approaches. Both proposed methods automatically calculate the wound area from an image. One method employs a two-dimensional system with the assistance of an external calibrator, while the other utilizes an Augmented Reality (AR) system, eliminating the need for a physical calibration object. To validate the correlation between these methods, a gold standard measurement with digital planimetry was employed. A total of 67 wound images were obtained from 41 patients between 22 November 2022 and 10 February 2023. The conducted pre-marketing clinical investigation demonstrated that the ML algorithms are safe for both the intended user and the intended target population. They exhibit a high correlation with the gold standard method and are more accurate than traditional methods. Additionally, they meet the manufacturer’s expected use. The study validated the performance, safety, and usability of the implemented methods as a valuable tool in the measurement of skin lesions.