(80 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 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.
§ 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.