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An AI-enabled handheld ESS device was developed as an objective aid for primary care physicians (PCPs) when managing lesions suspicious for skin cancer. The study compared diagnostic and management performance of 108 PCPs across 100 skin lesion cases with and without device output.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/derm-success-fda-pivotal-study-multi-reader-multi-case-evaluation/372399/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/derm-success-fda-pivotal-study-multi-reader-multi-case-evaluation/372399.png","ImageObject",300,407,{"name":92,"@type":93},"Alex Sinclair","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is Elastic Scattering Spectroscopy (ESS) and what problem does it address?","Question",{"text":112,"@type":113},"ESS is an optical tissue-sampling technique that distinguishes benign from malignant tissue in vivo without requiring surgical biopsy. It helps address the difficulty of evaluating suspicious skin lesions in primary care settings.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was the device effect evaluated in this clinical utility study?",{"text":117,"@type":113},"108 primary care physicians evaluated 100 skin lesion cases, with 50 cases aided by device output and 50 cases evaluated without it. For each case, physicians provided a diagnosis, management decision, and confidence level, initially without and then with device output.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the main outcomes when PCPs used the AI-enabled ESS device?",{"text":121,"@type":113},"Device output significantly increased diagnostic sensitivity (71.1% to 81.7%) and referral sensitivity (82.0% to 91.4%). 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Ferris 1, Erik Jaklitsch2, Elizabeth V. Seiverling2,3, Thomas Agresta4, Peggy Cyr5, Laurie Caines6, Na Wang7, and Daniel M. Siegel8  \nAbstract  \nBackground: Elastic Scattering Spectroscopy (ESS), an optical tissue sampling technique, distinguishes between benign and malignant tissue in vivo without the need to perform a surgical biopsy. A handheld device that employs ESS enabled with an artificial intelligence algorithm was developed as an objective tool to aid primary care physicians (PCPs) in their management of lesions suspicious for skin cancer. The aim of this study was to assess and compare the diagnostic and management performance of PCPs with and without the use of the ESS device in detecting skin cancer.  \nMethods: In this clinical utility study, 108 PCPs evaluated 100 skin lesion cases (50 aided with the device output and 50 unaided by the device). For each case, PCPs provided a diagnosis, management decision, and level of confidence in that decision initially without, and then subsequently with, device output. Sensitivity, specificity, AUC, and confidence in their assessment prior to, and then with, device output were compared.  \nResults: With visual assessment assisted by device output, diagnostic sensitivity increased significantly from 71.1% to 81.7%(P = .0085) and referral sensitivity increased significantly from 82.0% to 91.4%(P = .0027) compared to visual assessment only. Device-aided diagnostic specificity decreased from 60.9% to 54.7%(P = .1896), and referral specificity decreased from 44.2% to 32.4%(P = .0256). Overall management performance (ie, AUC) also increased from 0.708 to 0.762, and increased from 0.567 to 0.682 for lesions which physicians reported low confidence in their unassisted management decision. Physicians reporting high confidence in their management assessment increased from 36.8% to 53.4%.  \nConclusion: Use of the ESS device output by PCPs significantly improved their diagnostic and management sensitivities as well as their overall management performance. The findings suggest the ESS device can improve PCP skin cancer detection and confidence in their skin lesion evaluation and management.  \nKeywords  \nmelanoma, squamous cell carcinoma, basal cell carcinoma, artificial intelligence, machine learning, skin cancer, technology, diagnostic tools, elastic scattering spectroscopy  \nReceived: January 2, 2025; revised: April 8, 2025; accepted: April 15, 2025  \nIntroduction  \nSkin cancer is the most common malignancy in the U. S.1 The most common skin cancers are basal cell carcinomas (BCC) and squamous cell carcinomas (SCC), which arise from keratinocytes in the epidermis and are collectively referred to as keratinocyte carcinomas (KCs); approximately  \n5.4 million are diagnosed in the U. S. each year.2,3 Melanoma, the next most common type of skin cancer, has lower incidence but higher risk of mortality than KCs; in 2023, an estimated 186 680 new cases are expected tobe diagnosed in the  \nU. S. 1,2 In the U. S., approximately 7990 people die from melanoma and 8000 die from KCs each year. 1,4,5 Most skin  \nCreative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use,  \nreproduction and distribution of the work without further permissi","cbCaiib8W1a9k95x","https://ap.wps.com/l/cbCaiib8W1a9k95x","pdf",826754,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusion\n# Introduction","[{\"question\":\"What is Elastic Scattering Spectroscopy (ESS) and what problem does it address?\",\"answer\":\"ESS is an optical tissue-sampling technique that distinguishes benign from malignant tissue in vivo without requiring surgical biopsy. It helps address the difficulty of evaluating suspicious skin lesions in primary care settings.\"},{\"question\":\"How was the device effect evaluated in this clinical utility study?\",\"answer\":\"108 primary care physicians evaluated 100 skin lesion cases, with 50 cases aided by device output and 50 cases evaluated without it. For each case, physicians provided a diagnosis, management decision, and confidence level, initially without and then with device output.\"},{\"question\":\"What were the main outcomes when PCPs used the AI-enabled ESS device?\",\"answer\":\"Device output significantly increased diagnostic sensitivity (71.1% to 81.7%) and referral sensitivity (82.0% to 91.4%). Overall management performance (AUC) also increased (0.708 to 0.762), and physician confidence improved.\"}]","DERM-SUCCESS FDA Pivotal Study - Multi-Reader Multi-Case Evaluation | PDF",1790194431,23]