Search Results

The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEG (subject device) includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters, and connectors. The device is supplied sterile and is intended for single use in adults. Entuit PEGJ (subject device) includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr PEGJ tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.

There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has one feeding adapter that is ENFit compatible and two feeding adapters that are compatible with Christmas tree/slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are also available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit).

The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG kits are available in standard, safety, and international versions. The Entuit PEGJ is sold as a separate kit and available in standard versions.

I'm sorry, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a medical device. It discusses the device's intended use, comparison to a predicate device, and a summary of non-clinical testing.

However, the document does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

Ask a specific question about this device

The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

The Entuit PEG includes a silicone enteral feeding tube (PEG tube) available in 24 Fr or 20 Fr, with site preparation components, introduction components, adapters. The PEG tube is supplied sterile and is intended for single use in adults. Entuit PEGJ includes a polyurethane enteral feeding tube (PEGJ tube) that is available in 12 Fr or 9 Fr. The Entuit PEGJ tube is available for direct access to the jejunum. The 12 Fr PEGJ tube is designed to be inserted through the 24 Fr PEG tube and the 9 Fr tube is designed to be inserted through the 20 Fr PEG tube such that the distal end extends into the jejunum and the proximal end extends out of the existing PEG tube.

There are several feeding adapters for use with the PEG and PEGJ tubes. The PEG kit has two feeding adapters that are ENF it compatible and two feeding adapters that are compatible with Christmas tree or slip tip giving sets and syringes (Non-ENFit). The PEGJ tubes are available with either ENFit compatible or Christmas tree compatible feeding adapters (Non-ENFit). The Entuit PEG is provided as a kit to facilitate either push or pull techniques of placement. In addition, the Entuit PEG are available in standard, safety, and international versions. The PEGJ tubes are sold as a separate kit.

This document is an FDA 510(k) clearance letter for the Entuit PEG and Entuit PEGJ devices. It is a review of the substantial equivalence of these devices to a previously marketed predicate device. This document describes the device itself and its intended use, along with non-clinical testing conducted to demonstrate performance.

However, this document does NOT contain information about an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth for AI model training or testing.

Therefore, I cannot provide the requested information, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria. The provided text does not describe an AI medical device or its validation.

Ask a specific question about this device