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The Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

Submucous myomas
Endometrial Polyps
Retained products of conception

The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate TRUCLEAR Morcellator System:

• Tissue Removal Drive System
• Tissue Removal Device

The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.

This document is a 510(k) Summary for the Myosure Hysteroscopic Tissue Removal System. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of market clearance for an electromechanical medical device, not on evaluating the performance of an AI system against specific metrics.

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