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The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application In open or minimally invasive general abdominal, gynecologic, pediatre and thorado surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the perior, it e. low antentiment which and may be used for transection and resection of liver substance, hepatic vasculature and billiary stuctures 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 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 Reload with Tri- Stable™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles.

The provided text is a 510(k) summary for a medical device, the "Endo GIA™ Radial Reload with Tri-Staple™ Technology". This document describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance data.

However, the provided text does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The document pertains to a mechanical surgical stapling device, not an AI/ML system. Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions performance data, including "In Vitro (Firing Force, Retraction Force, Staple Formation)" and "In Vivo (Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Tissue Grasping and Trauma, Biocompatibility)". However, it does not provide specific acceptance criteria or quantitative performance results in a table format. It only states that the results "demonstrate that the proposed devices... are substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance: Not applicable as there is no AI/ML test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/ML ground truth.
4. Adjudication method: Not applicable as there is no AI/ML ground truth.
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 as this is a mechanical device, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an AI algorithm.
7. The type of ground truth used: Not applicable as this is a mechanical device.
8. The sample size for the training set: Not applicable as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable as there is no AI/ML training set.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, materials, and generic performance testing for a surgical stapler. It does not describe an AI/ML system or its validation process.

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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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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 of liver substance, hepatic vasculature and biliary structures.

The Endo GIA™ Radial Reload with Tri-Staple™ Technology is a curved stapler cartridge that places three staggered rows of staples on either side of a cut line and simultaneouly divides (cuts) the tissue between the rows.

Covidien Reloads with Tri-Staple™ Technology apply height progressive rows of titanium staples on either side of the cut line. The shortest staple length is located in the first staggered row nearest the knife, an intermediate staple length is located in the second row, and the longest staple length is located in the third (outside) staggered row.

The Endo GIA™ Radial Reload with Tri-Staple™ Technology is compatible with the Endo GIA™ ULTRA Universal Stapler and GIA™ and Endo GIA™ Universal Stapler handles, and incorporates the functionality of those handles including interlocks to prevent firing a previously fired cartridge.

The provided text describes a medical device, the "Covidien Endo GIA™ Radial Reload with Tri-Staple™ Technology," which is a surgical stapler cartridge. The document is a 510(k) summary for premarket notification, indicating its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to independently establish de novo acceptance criteria with a comprehensive study design as one might find for a novel diagnostic AI algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set details) are not applicable in this context, as they relate to the validation of AI/machine learning diagnostic devices or studies involving human interpretation. This document describes a surgical stapling device, which is validated through bench and animal performance evaluations.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available or not relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format that would typically be associated with AI/diagnostic device performance (e.g., specific sensitivity, specificity, or F1-score targets). Instead, the performance evaluations verify that the device is "safe and effective and performs as intended" through various bench and in vivo tests. The "reported device performance" is a general statement that these tests were "completed to verify" the safety and effectiveness.

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

• Sample Size for Test Set: Not specified. The document states "Bench and animal model performance evaluations were completed," but does not provide the number of samples, animals, or tests performed for each category.
• Data Provenance: The studies were conducted as "Bench and animal model performance evaluations." The country of origin is not specified, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were designed tests rather than retrospective analysis of existing data.

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

• Not Applicable. This is a surgical stapling device, not a diagnostic device requiring expert interpretation for "ground truth" establishment in a test set. The performance evaluations involved physical and biological tests.

4. Adjudication method for the test set

• Not Applicable. See point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert interpretations, which is not relevant to the physical and biological performance testing of a stapling device.

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 is not an AI-assisted diagnostic device. No human reader studies (MRMC) were conducted or are relevant to demonstrate the safety and effectiveness of a surgical stapler.

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

• Not Applicable. This device is a physical surgical stapler, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used

• Inferred Ground Truth: For the performance evaluations, the "ground truth" would be the direct measurement of physical properties (e.g., staple formation, firing force, pull-apart force, burst strength, air leak) and direct observation of biological outcomes (e.g., free bleed, tissue grasping, trauma) in controlled bench and animal models. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI/diagnostic device validation but rather objective measurement against predefined engineering and biological success criteria, though these criteria themselves are not explicitly detailed in the provided text beyond the general statement of "safe and effective."

8. The sample size for the training set

• Not Applicable. This is not a machine learning device. The concept of a "training set" does not apply. Design and development of the stapler would involve iterative testing and refinement, but not in the sense of a machine learning training set.

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

• Not Applicable. See point 8.

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