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Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips. These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope. When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

The provided document (K990687) is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended use, rather than detailing a study with specific acceptance criteria and performance metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not available in this type of regulatory submission. This document does not describe a study to prove the device meets acceptance criteria in the way a clinical trial report would. Instead, it describes the device and its intended use, and asserts its substantial equivalence to a previously cleared device.

However, I can extract information related to the device's functional description and intended use, which inherently defines some performance expectations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense. The "performance" described is largely functional and mechanical, demonstrating how the device operates and what it is designed to achieve in clinical use. The "criteria" are inferred from the device's intended use and design description, and the "performance" is a description of its operational mechanics.

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