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FTRD System: Instrument designed for flexible endoscopy. Instrument is designed for diagnostic tissue acquisition and full-thickness resection through the removal of suitable lesions in the colon and rectum. The FTRD System is indicated for the resection of lesions

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding the FTRD System Set, which is a medical device. It outlines the device's classification, regulatory requirements, and indications for use. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance against specific acceptance criteria.

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DTC Snare:
The DTC Snare is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for haemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions.
The clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of.

• Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects

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The provided document is a 510(k) summary for a medical device called the "DTC Snare" and related instruments (Marking Probe, Grasper). It is a letter from the FDA determining substantial equivalence to a predicate device. This type of document indicates that the device has met the safety and effectiveness requirements of the predicate device, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria, nor does it typically include details about sample sizes, ground truth establishment, or expert involvement for a new study demonstrating performance.

Instead, this document confirms the device is substantially equivalent to a legally marketed predicate device based on its indications for use, technological characteristics, and safety and effectiveness information, which often involves comparing to published data or previous submissions for the predicate.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance process rather than detailed performance study results of the DTC Snare itself.

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