Prospective Pilot Study of Robotic-Assisted Harvest of the Latissimus Dorsi Muscle: A 510(k) Approval Study with U.S. Food and Drug Administration Investigational Device Exemption.

Abstract

There are no U.S. Food and Drug Administration (FDA)-approved indications for robotic plastic surgery. This study was designed to demonstrate safety and efficacy of the robotic latissimus dorsi harvest for FDA approval. This prospective, single-arm study was conducted under an investigational device exemption through the FDA for obtaining 510(k) approval. The primary safety endpoint was adverse events attributable to harvest. Primary efficacy endpoints included muscle viability after harvest and