Regulatory clearance of a rehabilitation system for individuals with upper limb loss

摘要 到目前为止，我们的工作已经导致了几项专注于改善人们生活的技术的开发 上肢丧失(ULL)的个体。首先，我们的感官模式识别控制系统(和关联的 元素低轮廓表面肌电电极和Flexell柔性锂聚合物电池)可以与 市场上大多数肌电的手、手腕和肘部。第二，我们的MyoTrain虚拟肢体前假肢 培训系统已被演示，以帮助ULL患者学习使用模式识别。这个系统 在截肢后的“黄金窗口期”，但在可行之前，给病人配上 最终的假肢。 根据我们的临床经验，我们确定了三种方法来加深我们的临床影响， 尤其是与MyoTrain系统相关的。首先，我们注意到肌电分类的准确性可能是 通过减少类内分散(提高重复性)和/或增加类间分离来改进 (提高可分离性)。个人如何结合这些方法是用户特定的，他们可以受益于 整合视觉反馈--这就是我们所说的“积极指导”。第二，我们的商业模式 允许我们在获得报销之前向患者提供MyoTrain，这将提供重要的临床 优势。然而，目前这仍然需要修复师制造用于 每一个人。我们现在建议集成一个可重复使用的无线臂章，这将消除这个问题。 第三，我们计划通过对我们的技术套件进行前瞻性试验来评估MyoTrain的疗效 相关的临床方法学。具体地说，我们将测试三个假设：1)使用MyoTrain结果 2)MyoTrain中的虚拟结果测量是 与真实世界的功能结果测量相关；以及3)MyoTrain的使用改善了临床结果 由功能、主观和使用指标衡量的结果。这个项目的顶峰是 提交MyoTrain系统的510(K)上市前通知申请。

ABSTRACT Our work to date has resulted in the development of several technologies focused on improving the lives of individuals with upper-limb loss (ULL). First, our Sense pattern recognition control system (and associated Element low-profile surface EMG electrodes and FlexCell flexible lithium-polymer batteries) can interface with most myoelectric hands, wrists, and elbows on the market. Second, our MyoTrain virtual-limb pre-prosthetic training system has been demonstrated to help individuals with ULL learn to use pattern recognition. This system is valuable in the “golden window” time period after amputation but before it is feasible to fit the patient with a definitive prosthesis. Based on our clinical experience, we identified three ways in which we could deepen our clinical impact, particularly as related to the MyoTrain system. First, we noted that EMG classification accuracy could be improved by decreasing intra-class scatter (improving repeatability) and/or increasing inter-class separation (improving separability). How individuals incorporate these methods is user specific and they could benefit from the incorporation of visual feedback – something that we call “Active Coaching”. Second, our business model allows us to provide MyoTrain to the patient before reimbursement is available, which offers significant clinical advantage. However, this currently still requires the prosthetist to fabricate a check socket for use with each individual. We now propose to integrate a reusable wireless armband which would eliminate this issue. Third, we plan to evaluate the efficacy of MyoTrain with a prospective trial of our technology suite and associated clinical methodology. Specifically, we will test three hypotheses: 1) use of MyoTrain results in skills transference to control of the final prosthesis; 2) the virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures; and 3) use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics. The capstone of this project is the submission of a 510(k) premarket notification application for the MyoTrain system.