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For the precise depth control of probes during stereotactic neurosurgical procedures.

The CRW-FMD is designed for the precise depth control of probes during stereotactic neurosurgical procedures. The CRW-FMD is mounted to a stereotaxic frame, and manually operated to advance a probe along the z-axis of a stereotactic trajectory. The main components of the system are: guide block base, stanchion probe holder, drive stanchion, drive box, digital display, and cable

The provided text is a 510(k) summary for the Cosman Robert Wells Functional Probe Microdrive (CRW-FMD). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, the provided document does not contain the information required to populate the tables and answer the questions related to acceptance criteria and a study proving the device meets them.

The document states:

• "The technological characteristics are the same or similar to those found with the predicate device."
• It claims substantial equivalence to "the Microdrive for Probes, an accessory for the Todd Wells Stereotaxic Guide that was commercially available prior to May 28, 1976."

This suggests that the 510(k) relies on the known performance and characteristics of the predicate device, rather than new, explicit performance studies with specific acceptance criteria conducted for the CRW-FMD in this submission.

Without a dedicated performance study, I cannot provide the requested information.

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