Mihcin Senay, Strehlow Jan, Demedts Daniel, Schwenke Michael, Levy Yoav, Melzer Andreas
a School of Medicine, University of Dundee , Dundee , UK.
b Fraunhofer MEVIS , Bremen , Germany.
Minim Invasive Ther Allied Technol. 2017 Jun;26(3):151-161. doi: 10.1080/13645706.2016.1273836. Epub 2017 Jan 13.
The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice.
The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation.
Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05).
The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.
新型Trans-Fusimo治疗系统（TTS）旨在控制磁共振引导聚焦超声（MRgFUS）疗法，以在呼吸运动下消融肝脏肿瘤。通过MRgFUS有效治疗肝脏肿瘤时，将声功率控制在公差范围内至关重要。在临床应用之前，可重复性和可靠性的证据是安全操作的必备条件。
TTS软件通过ExAblate-2100适形骨系统（CBS）换能器输送声功率。开发了一个内置的质量保证应用程序来测量力值，使用一种新颖的协议来测量100W和150W电功率值在6秒超声处理下的效率。两名独立用户针对临床批准的ExAblate-2100 CBS重复此过程30次以进行交叉验证。
两个系统都证明能在可接受的效率水平（70-90%）内输送功率。使用双样本t检验评估ExAblate-2100 CBS和TTS之间力值的差异（p>0.05）。使用Bland-Altman图来展示两个系统之间的一致性界限落在10%的一致性界限内。双样本t检验表明TTS不存在用户依赖性（p>0.05）。
TTS软件证明能输送声功率且不超过安全水平。结果为CE标志目的提供了作为ISO13485法规一部分的证据。当TTS用于临床实践时，所开发的方法可作为临床环境中质量保证系统的一部分加以利用。
