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The Tri-Staple™ 2.0 Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

The Tri-Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue.

The Tri-Staple™ 2.0 Reloads and Tri-Staple™ 2.0 curved tip reloads place staggered rows of titanium staples and simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the single use reload:

The Tri-Staple™ 2.0 reload is available in articulating 30 mm, 45 mm and 60 mm length, the Tri-Staple™ 2.0 curved tip reload is available in articulating 30 mm, 45 mm lengths and the Tri-Staple™ 2.0 black reload is available in articulating 45 mm and 60 mm lengths.

The Tri-Staple™ 2.0 reloads and Tri-Staple™ 2.0 curved tip reloads can be used with the GIA™ universal stapler, Endo GIA™ universal staplers, Endo GIA™ Ultra universal staplers, and Covidien™ powered stapler handles used with Endo GIA™ adapters.

This document is a 510(k) summary for a medical device called "Tri-Staple™ 2.0 Reloads." It's a regulatory submission to the FDA, demonstrating that the device is substantially equivalent to a previously cleared predicate device.

Based on the provided text, there is no information available about acceptance criteria and a study proving a device's performance in the context of an AI/ML medical device.

The document discusses a stapling reload device and focuses on:

• Device Name: Tri-Staple™ 2.0 Reloads
• Purpose of Submission: A line extension to expand the reorder code offering by adding a "1-Wire ID-chip assembly" to existing Endo GIA™ Reloads with Tri-Staple™ Technology. This chip enables communication between the reloads and a powered stapler handle (Signia™ Stapler).
• Substantial Equivalence: The primary argument is that adding the ID chip does not alter the intended use, indications, or user environment of the device, making it substantially equivalent to the cleared predicate device (K160176 - Signia™ Stapler).
• Studies Performed:
  • Non-clinical performance data or testing: "No new non-clinical performance data or testing has been performed." The rationale is that the technology and design of the 1-Wire ID-chip remain the same as previously cleared in K160176. Existing design verification is considered transferable.
  • Clinical performance data: "No clinical study has been performed."

Since this document pertains to a surgical stapler reload and its electrical communication feature (an ID chip), and not an AI/ML-based device, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth, sample sizes, expert qualifications, adjudication methods, and MRMC studies is simply not present in this text.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance validation.

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