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The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue.

The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.

The TA™ Stapler with DST Series™ Technology with a TA™ Loading Unit with DST Series™ Technology is a modular stapling system indicated for use during transection of tissue during surgical procedures.

The TA™ Stapler is a handheld mechanical stapler handle used to position and deploy TA™ Loading Units, which are staple cartridges containing titanium staples. The TA™ staplers and TA™ Loading Units are supplied sterile. To perform its intended use, the distal shaft of a TA™ Stapler is assembled with a TA™ loading unit. The TA™ Stapler acts as a stapler handle used by the surgeon to insert and position the TA™ Loading Units inside the body via an incision. The TA™ Loading Unit is then mechanically activated by the surgeon by squeezing the handle of the TA™ stapler, thereby deploying staggered rows of titanium staples to close incisions in abdominal and thoracic tissue. The TA™ Stapler is reloadable meaning the surgeon can manually remove a fired TA™ Loading Unit and replace it with a new TA™ Loading Unit for subsequent firing in a single patient surgical procedure. The TA™ Stapler can be reloaded up to 7 times for a total of 8 firings per instrument.

The TA™ Staplers with DST Series™ Technology are available with staple line anvil lengths that accommodate 30, 45, 60 and 90 mm length TA™ Loading Units. The TA™ Loading Unit with DST Series™ Technology are available with staple heights of 2.5 mm (white vascular cartridge, 3 rows of staples, 30 mm length only); 3.5 mm (blue cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths); 4.8 mm (green cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths).

The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

I am sorry, but there is no information about acceptance criteria or specific studies to prove device performance in the provided text. The document is an FDA 510(k) clearance letter and a 510(k) summary for a surgical stapler. It describes the device, its indications for use, its substantial equivalence to a predicate device, and the types of non-clinical performance data that were submitted (bench top, ex-vivo, in-vivo pre-clinical testing, biocompatibility, shelf life, usability, and MR safety). However, it does not provide quantitative acceptance criteria or detailed results of these studies. Therefore, I cannot generate the table or answer the specific questions you've asked.

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