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Monitor and record intra-cardiac electrical activities

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This document is a premarket notification (510(k)) for a medical device called the "Gyro Tip EP Catheter." It is for a device used to "monitor and record intra-cardiac electrical activities."

Unfortunately, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document is primarily a summary for a 510(k) submission, focusing on:

• Device Identification: Name, classification, intended use.
• Regulatory Information: Manufacturer registration, classification.
• Labeling: Mention of draft labeling, including directions for use, indications, cautions, warnings, and precautions.
• Substantial Equivalence: A claim that the device is substantially equivalent to existing devices (Bard Dynamic Tip Catheter, Bard Tip Deflecting Catheter, Bard Tip Deflecting Electrode Catheter, and Steerocath).
• General Information: Reference to a more comprehensive summary for material biocompatibility, physical characteristics, and results of electrical and mechanical tests.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, or expert involvement as requested. The "None Established Performance Standards" point further reinforces that no specific numerical performance standards are detailed in this summary.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided text.

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