Performance of a computer-aided digital dermoscopic image analyzer for melanoma detection in 1,076 pigmented skin lesion biopsies

Background: Digital dermoscopic image analysis of pigmented skin lesions (PSLs) has become increasingly popular, despite its unclear clinical utility. Unbiased, high-powered studies investigating the efficacy of commercially available systems are limited. Objective: To investigate the diagnostic performance of the FotoFinder Mole-Analyzer in assessing PSLs for cutaneous melanoma. Methods: In this 15-year retrospective study, the histopathologies of 1076 biopsied PSLs among a total of 2500 imaged PSLs were collected. The biopsied PSLs were categorized as benign or malignant (cutaneous melanoma) based on histopathology. Analyzer scores (0-1.00) for these PSLs were obtained and grouped according to histopathology. Results: At an optimized cutoff score of 0.50, a sensitivity of 56% and a specificity of 74% were achieved. The area under the receiver operating characteristics curve was 0.698, indicating poor accuracy as a diagnostic tool. Limitations: This study had a retrospective design and involved only a single institution. Conclusion: Our study reveals a low sensitivity of the scoring function of this digital dermoscopic image analyzer for detecting cutaneous melanomas. Physicians must apply keen clinical judgment when using such devices in the screening of suspicious PSLs.