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This device is intended for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves. This device is indicated for locating and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.

NIM Spine is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. The monitoring console uses both video and audio output. Responses monitored with the device may originate from operator applied electrical stimulus or from direct or indirect mechanical stimulus occurring during the course of the surgery. Acquired data may be stored on various types of durable media, and hard copy may be obtained via an optional printer.

The provided text is a 510(k) summary for the Medtronic Xomed NIM Spine device, an intraoperative neurophysiological monitor. It aims to establish substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria.

The 510(k) summary focuses on device description, indications for use, and a comparison to predicate devices to prove substantial equivalence. It does not detail performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary often summarizes performance data presented in the full 510(k) submission, but this particular summary does not include that level of detail.

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