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The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar,

The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

The Origin Classic Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision cite. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

I am sorry, but based on the provided text, I cannot provide the requested information. The text describes a "Resposable Trocar System" and its substantial equivalence to a predicate device, focusing on its intended use, materials, and technological characteristics.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

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