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To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.

The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.

The provided text is a 510(k) summary for a medical device called "Recording and Stimulating Electrode." It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with detailed acceptance criteria and results.

Therefore, the input document does not contain information related to acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies.

The document primarily states:

• The device is a "Recording and Stimulating Electrode" intended "To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures."
• It is considered substantially equivalent to two predicate devices: Radionics Microelectrode Kit (K991399) and Microrecording Systems Consultants, LLC, Microelectroencephalography Professional System 5000 (K991077).
• No applicable performance standards have been issued under section 514 of the Food, Drug & Cosmetic Act.
• The FDA has made a substantial equivalence determination, allowing the device to be marketed.

Without a detailed performance study described in the provided text, it is impossible to populate the requested table and answer the specific questions about acceptance criteria, study details, and ground truth establishment.

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