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The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.

The catheters are typically placed percutaneously through femoral or jugular access sites and directed through the vasculature into the cardiac chambers. The catheter is composed of a wirereinforced, polyurethane shaft and a soft, distal tip. The distal end of the catheter is fitted with three ring electrodes and one tip electrode. No new electrode geometries are introduced. Catheters with various tip lengths are available to meet anatomical constraints as well as physician preference and technique.

The provided text is a summary of safety and effectiveness for an Electrode Recording Catheter, submitted by Boston Scientific Corporation in 1996. It describes the device, its intended use, and general performance characteristics. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets them, or details about ground truth, expert involvement, and sample sizes.

The document states:

• "The results demonstrated functional integrity and performance characteristics that were substantially equivalent and acceptable for the device's intended use and do not affect safety and effectiveness."
• "Mechanical, electrical and biological tests verify that the electrode recording catheter meets the essential requirements that are considered necessary for its intended use."

These statements indicate that tests were performed and deemed acceptable, but the specific acceptance criteria, detailed study methodology, and quantitative results are not provided.

Therefore, I cannot populate the requested tables and sections with the information present in the input text. The input focuses on regulatory submission details and general safety/effectiveness claims, rather than a detailed performance study with specific metrics and methodologies.

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