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The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.

The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation.

The gi2000 consists of the high-frequency electrosurgical unit with control panel and an operating foot switch. The handpiece (electrodes) and dispersive pad (return electrode) are not included with the gi2000. Instead, device labeling lists optional pieces that have been validated with the device.

The provided text is a 510(k) clearance letter for an electrosurgical generator (gi2000). While it describes the device, its intended use, and generally mentions that performance testing was completed, it does not contain the specific acceptance criteria or detailed study results as typically found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

The 510(k) summary states, "Performance testing on the gi2000 was completed by three methods," and then lists the types of studies: ex-vivo comparative study, accessory compatibility study, and in-vivo preclinical test. However, it only references internal document IDs (e.g., "40-0036-11 DS, Predicate Device Comparative Study Report, gi2000") rather than providing the data itself.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and device performance, sample sizes, expert qualifications, or multi-reader multi-case studies from the provided text. The document confirms that performance testing was done and demonstrated substantial equivalence, but it does not present the specific data points to fill out your requested table and study details.

To address your request, I would need a document that contains the actual results of these performance tests, including the quantitative acceptance criteria and the values measured for the gi2000.

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