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The GIATM stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length. The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure.

This document is a 510(k) summary for a medical device called the "GIA™ Stapler with Tri-Staple™ Technology". It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to a legally marketed predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/Software device meets acceptance criteria. The document is for a surgical stapler, which is a physical medical device, not a software or AI product.

Therefore, I cannot provide the requested information, as the input document does not contain details about an AI medical device or its validation studies.

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