(28 days)
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.
§ 876.5360 Laparoscopic gastrointestinal sizing tool.
(a)
Identification. A laparoscopic gastrointestinal sizing tool is a prescription use device intended for laparoscopically measuring an extraluminal dimensional parameter of the indicated gastrointestinal organs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate that the sizing tool performs as intended under anticipated conditions of use. Performance testing must include the following:
(i) Trocar compatibility, which includes shaft bending force characterization;
(ii) Joint strength tensile testing;
(iii) Distal loop extension/retraction force characterization;
(iv) Material selection analysis, which includes corrosion and visual inspection; and
(v) Accuracy of the dimensional measurement.
(2) Performance testing must support the sterility and/or reprocessing and shelf life of the patient-contacting components of the device.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Labeling of the device must include the following:
(i) A statement regarding metal allergies if the device is made from metallic components;
(ii) Specific instructions for proper device use including information regarding the following:
(A) Inspection of device prior to use;
(B) Surgical access techniques or methodologies;
(C) Instructions for avoiding structural damage to vagus nerve bundle;
(D) Trocar compatibility;
(E) Sizing methodology; and
(F) Minimum and maximum dimensional parameters that the device is capable of measuring.
(iii) Identification of the associated parent device with which the sizing tool has been demonstrated to be compatible; and
(iv) An expiration date.