Search Results

The ENSEAL® G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.

The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The ENSEAL® G2 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.

The Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers are for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with a foot switch.

The document provided is a 510(k) summary for the ENSEAL® G2 Tissue Sealers, an electrosurgical device. It describes the device, its intended use, and states that performance data was collected, but it does not provide specific acceptance criteria or the detailed results of a study demonstrating the device meets those criteria, nor does it describe an AI/ML algorithm.

Therefore, I cannot populate the requested table or answer most of the questions related to acceptance criteria, device performance, sample sizes, expert involvement, adjudication, or AI/ML study details, as this information is not present in the provided text.

Here's what I can extract based on the given document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report specific performance metrics. It generally states that "Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study were conducted to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Tissue Sealers perform as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing and laboratory evaluations in an animal model including an acute and a 30-day chronic survival study," but does not specify the sample size for these studies or the provenance of the data. It does indicate animal models were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, no MRMC comparative effectiveness study involving AI was conducted or reported.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, no standalone algorithm performance study was conducted or reported.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The document refers to "Bench testing and laboratory evaluations in an animal model," implying that the "ground truth" would be based on direct observation of sealing efficacy, tissue transection, and adverse events in the animal models, likely evaluated by experts in veterinary medicine or surgical research, potentially supplemented by histological (pathology) examination. However, specific details are not provided.

8. The sample size for the training set

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, there is no training set mentioned.

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

This document describes an electrosurgical device, not an AI/ML algorithm. Therefore, this question is not applicable.

Ask a specific question about this device