Search Results

The Applied Medical Laparoscopic Guidewire is intended to assist the physician in navigation, placement and exchange of laparoscopic and general surgical instrumentation.

The Applied Medical Laparoscopic Guidewire is substantially equivalent in function, physical configuration and materials to the Applied Medical Urological Guidewire approved under K944135/A and a guidewire marketed by Cook Urological under K880100. The Applied Medical Laparoscopic guidewire and the predicate devices have a radiopaque body with a flexible, tapered tip allowing ease of access and visibility during placement. Differences include a change of indicated use and a selection of different lengths.

This document is a 510(k) summary for the Applied Medical Laparoscopic Guidewire, submitted in 1997. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not provide the information requested in the prompt regarding acceptance criteria and study details related to device performance in an AI/software context.

The information requested, such as sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment, is typically associated with the evaluation of AI-powered medical devices or diagnostic software. The Applied Medical Laparoscopic Guidewire is a physical medical instrument, and its approval process outlined here focuses on mechanical, biocompatibility, and substantial equivalence to existing predicate devices.

Therefore, I cannot extract the requested information from the provided text because it is not relevant to this type of medical device submission.

Ask a specific question about this device