(75 days)
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:
- 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."
- Sample size used for the test set and the data provenance: Not applicable as there is no AI/ML test set.
- 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.
- Adjudication method: Not applicable as there is no AI/ML ground truth.
- 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.
- 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.
- The type of ground truth used: Not applicable as this is a mechanical device.
- The sample size for the training set: Not applicable as there is no AI/ML training set.
- 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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.