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The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The single use Endo GIA™ radial reload with Tri-Staple™ technology places three radial (curved) staple rows 60mm in length on each side of a cut line and simultaneously divides the tissue between the third and fourth lines, creating a 60mm curved transection. The medium/thick radial reload places height progressive titanium staple rows. The reloads may be inserted through an access device such as a hand access device or comparable access port. The Endo GIA™ radial reloads with Tri-Staple™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles.

The provided text describes a 510(k) summary for the "Endo GIA™ Radial Reload with Tri-Staple™ Technology," a surgical stapler. However, it does not contain specific acceptance criteria, detailed results from a study, or the information needed to fill out all the requested categories.

The document states that "Design verification and pre-clinical validation studies were conducted to demonstrate that the subject device Endo GIA™ Radial Reload are safe and effective and perform as intended." It lists categories of tests conducted: "In Vitro" (Firina Force, Retraction Force, Staple Formation) and "In Vivo" (Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Tissue Grasping and Trauma, Biocompatibility). It concludes that "The result of these tests demonstrates that the subject device Endo GIA™ Radial Reload with Tri-Staple Technology is substantially equivalent to the predicate device."

Based on the provided text, I cannot complete the requested tables and information as many specific details are missing. For instance, it doesn't give precise numerical acceptance criteria, the reported device performance against those criteria, sample sizes, data provenance details, expert qualifications, adjudication methods, or information regarding AI assistance, standalone algorithm performance, or ground truth establishment for training sets.

Therefore, I can only provide a general description of what the document implies about the studies, noting the missing information.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: The studies were "Design verification and pre-clinical validation studies" including "In vitro and in vivo testing." No country of origin is mentioned, nor is it specified if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a medical device (surgical stapler), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" would be related to mechanical performance and biological outcomes, verified through instrumental measurements and observable biological effects in the tests mentioned (e.g., successful staple formation, absence of air leaks, no excessive bleeding, tissue integrity).

4. Adjudication method for the test set:

• Not applicable for this type of device testing. Performance is evaluated against engineering and biological criteria, not expert consensus on interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a surgical stapler, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a surgical stapler, not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" would be objective measurements and observations from the in vitro (e.g., force measurements, visual inspection for staple formation) and in vivo (e.g., observation of bleeding, pressure tests for leaks, histological examination for tissue trauma) tests. It is based on established engineering and biological performance standards for surgical staplers.

8. The sample size for the training set:

• Not applicable. This device is a surgical stapler and does not involve AI training sets.

9. How the ground truth for the training set was established:

• Not applicable. This device is a surgical stapler and does not involve AI training sets or associated ground truth establishment.

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