Mixed Reality Surgical Navigation System; Positional Accuracy Based on Food and Drug Administration Standard.

IF 1.2 4区 医学 Q3 SURGERY
Surgical Innovation Pub Date : 2024-02-01 Epub Date: 2023-11-29 DOI:10.1177/15533506231217620
Christopher T Morley, David M Arreola, Long Qian, Amy L Lynn, Zachary P Veigulis, Thomas F Osborne
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引用次数: 0

Abstract

Background: Computer assisted surgical navigation systems are designed to improve outcomes by providing clinicians with procedural guidance information. The use of new technologies, such as mixed reality, offers the potential for more intuitive, efficient, and accurate procedural guidance. The goal of this study is to assess the positional accuracy and consistency of a clinical mixed reality system that utilizes commercially available wireless head-mounted displays (HMDs), custom software, and localization instruments.

Methods: Independent teams using the second-generation Microsoft HoloLens© hardware, Medivis SurgicalAR© software, and localization instruments, tested the accuracy of the combined system at different institutions, times, and locations. The ASTM F2554-18 consensus standard for computer-assisted surgical systems, as recognized by the U.S. FDA, was utilized to measure the performance. 288 tests were performed.

Results: The system demonstrated consistent results, with an average accuracy performance that was better than one millimeter (.75 ± SD .37 mm).

Conclusion: Independently acquired positional tracking accuracies exceed conventional in-market surgical navigation tracking systems and FDA standards. Importantly, the performance was achieved at two different institutions, using an international testing standard, and with a system that included a commercially available off-the-shelf wireless head mounted display and software.

混合现实外科导航系统;基于食品药品监督管理标准的定位精度。
背景:计算机辅助手术导航系统旨在通过为临床医生提供手术指导信息来改善结果。混合现实等新技术的使用为更直观、高效和准确的程序指导提供了可能。本研究的目的是评估临床混合现实系统的位置准确性和一致性,该系统利用市售的无线头戴式显示器(hmd)、定制软件和定位仪器。方法:独立团队使用第二代Microsoft HoloLens©硬件、Medivis SurgicalAR©软件和定位仪器,在不同的机构、时间和地点测试组合系统的准确性。计算机辅助手术系统的ASTM F2554-18共识标准被美国FDA认可,用于测量性能。执行了288次测试。结果:系统显示出一致的结果,平均精度性能优于1毫米(。75±SD .37 mm)。结论:独立获取的定位跟踪精度超过了市场上传统的外科导航跟踪系统和FDA标准。重要的是,该性能是在两个不同的机构中实现的,使用了国际测试标准,并使用了一个包含商用现货无线头戴式显示器和软件的系统。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Surgical Innovation
Surgical Innovation 医学-外科
CiteScore
2.90
自引率
0.00%
发文量
72
审稿时长
6-12 weeks
期刊介绍: Surgical Innovation (SRI) is a peer-reviewed bi-monthly journal focusing on minimally invasive surgical techniques, new instruments such as laparoscopes and endoscopes, and new technologies. SRI prepares surgeons to think and work in "the operating room of the future" through learning new techniques, understanding and adapting to new technologies, maintaining surgical competencies, and applying surgical outcomes data to their practices. This journal is a member of the Committee on Publication Ethics (COPE).
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