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Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

A stereotactic system with an electromechanical, multi jointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments.

This Renishaw Mayfield 510(k) summary does not contain information about acceptance criteria and a study demonstrating the device meets those criteria. Instead, it describes a device (Neuromate Frameless Gen II) as a technical update of a previously cleared predicate device (Frameless Neuromate). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria with a dedicated study.

Specifically, the document states:

• No clinical data are submitted (Section 8). This indicates that there was no human-based study to assess the device's performance against clinical endpoints or acceptance criteria.
• Bench and performance testing showed that neuromate performed as designed and intended (Section 7). This refers to engineering-level testing to verify the device's functionality and compliance with standards (IEC 60601-1, IEC 60601-1-2, FDA software guidance, and IEC 62304), but it does not detail specific acceptance criteria or an associated study.
• The primary justification for market clearance is that the device "is equivalent in design and performance to the predicate device" (Section 9). The "Substantial Equivalence Summary" (Section 10) compares the new device to the predicate across various characteristics, noting similarities and minor differences.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them based on the provided text, as this type of information is not present in the document.

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