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The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.

The FemRx 100°SR™ System is a refined urologic resectoscope. A standard telescope is inserted into the device and coupled to an operative video camera system prior to use. The device is compatible with a variety of standard electro-surgery units (ESUs).

The system is designed to cut and coagulate prostate tissue by sliding the loop assembly in an axial manner relative to the handle/spring housing. Cutting and coagulation are accomplished by energizing the electrode with electrocautery current from an approved ESU. All cutting/coagulating occurs under visual control by a surgeon observing a video monitor displaying the view through the telescope. Cutting/coagulating is only performed while the device is moving towards the operator. Typically, the surgeon squeezes the finger rings to move cutting end distally; electrocautery is then applied and cutting/coagulating is accomplished by the active end as the spring returns the device to the most proximal resting location. The surgeon uses hand pressure to control the rate of sliding of the active end within the sheath. Separate channels are provided for irrigant inflow and outflow, permitting continuous fluid circulation for good visibility.

This document describes a medical device, the FemRx TURPSR™ System, which is a urological resectoscope. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and does not contain information related to acceptance criteria, a study proving performance against such criteria, or any of the detailed aspects requested in your prompt regarding AI/algorithm performance.

Therefore, I cannot extract the requested information from the provided text. The document describes a traditional surgical instrument and not a device incorporating AI or requiring performance validation against specific algorithmic metrics.

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