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The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The US Endoscopy Distal Attachment Cap is intended for the following.

• Gastrointestinal mucosal resection (endoscopic mucosal resection) .
• Keeping the suitable depth of the endoscope's view field

The US Endoscopy Distal Attachment Cap has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The provided document is a 510(k) premarket notification letter from the FDA to United States Endoscopy Group, Inc. regarding their device, "The US Endoscopy Distal Attachment Cap." This document confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain a detailed study description with specific acceptance criteria and performance data. The FDA letter is a regulatory approval, not a scientific study report. It merely states that "we have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the manufacturer submitted a study or data to the FDA, but the details of that study, including the acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics, are not present in this letter.

Therefore, I cannot provide the requested information from this document. The letter itself does not describe the acceptance criteria or a specific study that proves the device meets those criteria.

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