Search Results

The Linvatec 3-CCD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

The Linvatec 3-CCD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads may be sterilized using steam sterilization. The Linvatec 3-CCD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.

This document, K031098, for the "3-CCD Digital Camera System" does not contain information on acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, training set details, or how ground truth for the training set was established.

The document is a 510(k) Summary of Safety and Effectiveness, which primarily focuses on establishing substantial equivalence to legally marketed predicate devices. It describes the device, its intended use, and states that there are no significant differences that raise issues of safety or effectiveness compared to the predicates. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device