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The ETHICON LINX® Esophagus Sizing Tool for the LINX Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.

The LINX Esophagus Sizing Tool is a sterile, single-use device that is used as an accessory to the LINX Reflux Management System (packaged separately). The device has a soft, circular curved tip that is actuated by coaxial tubes via a handset. The handset contains numerical indicators that correspond to the size range of the LINX implant.

The provided FDA 510(k) summary for the ETHICON LINX® Esophagus Sizing Tool (K230089) does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/Machine Learning device performance evaluations.

This document describes a premarket notification for a laparoscopic gastrointestinal sizing tool, which is a physical accessory used to estimate the appropriate size of another medical device (the LINX Reflux Management System implant). The FDA filing states that:

• "No laboratory evaluations or bench testing were conducted to demonstrate that the LINX Esophagus Sizing Tool is equivalent to the predicate."
• "No bench tests were performed to support substantial equivalence to the predicate."
• "No animal tests were performed to demonstrate substantial equivalence to the predicate."
• "This premarket notification does not rely on human clinical data to demonstrate substantial equivalence."

The basis for this 510(k) clearance is that the device is substantially equivalent to a legally marketed predicate device (ETHICON LINX® Esophagus Sizing Tool, K201035, cleared 09 July 2020) and that the changes described in the submission "do not affect the intended use of the device or alter the fundamental scientific technology of the device." The changes primarily relate to updated "Instructions for Use" for clarity on implanting.

Therefore, I cannot provide the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement, as such studies were explicitly not conducted or relied upon for this specific 510(k) clearance. This device is not an AI/ML device, and its clearance process relied on substantial equivalence to a predicate device rather than performance metrics from new studies.

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The ETHICON Linx® Esophagus Sizing Tool for the LINX® Reflux Management System is a laparoscopic accessory used to estimate the appropriate size LINX® device.

The ETHICON Linx Esophagus Sizing Tool (also referred to as LINX® Esophagus Sizing Tool, hereafter) is an accessory to the LINX Reflux Management System implant (packaged separately). The LINX Esophagus Sizing Tool is a single use disposable device that is provided sterile. The LINX Esophagus Sizing Tool is a laparoscopic instrument and has two ends – the handset, considered the proximal end and not intended for patient contact, and the shaft with protruding circular curved tip, considered the distal end and is intended for limited contact with the patient. The handset is designed with a thumbwheel for one-handed operation. When actuated, the thumbwheel advances and retracts the soft polymeric circular curved tip of the distal end. The handle has a numerical indicator which directly correlates with the number of beads for the range of sizes of the approved LINX implant device. The shaft and distal end of the circular curved tip each have a magnet which allows the user to create a loop and attach the magnets to each other. Once the magnets are attached, the user retracts slack from the soft distal end until the loop is in circumferential contact with the esophagus. The LINX Esophagus Sizing Tool is utilized at the time of implant to associate the esophagus size to a LINX implant device size to aid in guiding the user into choosing an appropriately sized LINX implant device.

The provided text describes the 510(k) premarket notification for the ETHICON Linx® Esophagus Sizing Tool. Based on the content, this device is a laparoscopic accessory used to estimate the appropriate size of a LINX® Reflux Management System implant. It is a physical medical device and not an AI/software device.

Therefore, the requested information (acceptance criteria, study details, expert involvement, ground truth, etc., typically associated with the validation of AI/software for diagnostic or image-based tasks) is not applicable to this submission.

The FDA 510(k) clearance process for this type of physical device primarily relies on bench testing, biocompatibility, sterilization/shelf life, and demonstrating substantial equivalence to a predicate device based on technological characteristics and performance, rather than clinical trials or AI/MRMC studies.

The document explicitly states:

• "Neither the subject device nor predicate device uses software." (Page 4)
• "No animal tests were performed to demonstrate substantial equivalence to the predicate as it was deemed as not required." (Page 5)
• "This premarket notification does not rely on human clinical data to demonstrate substantial equivalence." (Page 5)

As such, I cannot provide a table of acceptance criteria and study data in the format requested, as the type of rigorous validation typically applied to AI-powered diagnostic tools (with ground truth establishment, expert consensus, MRMC studies, etc.) was not performed or required for this device.

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