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The Rusch Memory Bag is intended to be used for tissue extraction during laparoscopic procedures including cholecystectomy, appendectomy, nephrectomy, laparoscopic colon surgery, thoracoscopy, lymphadenectomy, tubal pregnancy, intestinal hysterectomy and myomectomy.

The Rusch Memory Bag will be offered in two (2) sizes -200ml bag with a 5cm opening for use with a 10mm trocar and an 800ml bag with a 10cm opening for use with a 10mm or 12mm trocar. The 10mm and 12mm application 800ml bags will each have separate and appropriately sized sheaths for insertion into the trocar. Each device consists of a polyurethane bag with a Nitinol wire, a polyethylene pusher and a polyethylene sheath.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for a medical device called the "Rüsch Memory Bag," which details its equivalence to existing devices, its intended use, and technological characteristics. It does not include information about performance studies or specific acceptance criteria for its functionality.

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