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The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophaqus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Catheter .
• Stellartech Coagulation Catheter Connection Module ●
• Stellartech Coagulation Generator .
• Stellartech Sheath .
• Optional Stellartech Footswitch. ◆
• Optional Stellartech Pressure Gauge
• Optional Stellartech Sizing Catheter .
• 후 Optional Stellartech Sizing Sheath
  The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of the Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

The provided document is a 510(k) safety summary for the Stellartech Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (electrosurgical unit), not an AI/ML device, and thus does not involve the types of studies and criteria typically associated with AI/ML performance evaluation.

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