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The MaxBraid BroadBand Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

Both MaxBraid BroadBand and Expressbraid Broadband Suture consist of a stainless steel straight or curved needle attached to a strand 1.25mm flat suture with round USP size 1 suture ends or 1.5mm flat suture with round USP size 2 suture ends in 38″ lengths. MaxBraid Broadband suture is straight with a single crimped needle, whereas the Expressbraid Broadband suture is a looped construct (both ends crimped into a single needle). The MaxBraid BroadBand Sutures are braided, non-absorbable sutures available in an all blue suture [Chromium-cobaltaluminum-oxide

This document, K160854, describes the substantial equivalence determination for the MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture. It does not contain information about an AI-powered device or a study involving human readers and AI assistance. Therefore, it is not possible to answer the questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment from the provided text.

The document primarily focuses on demonstrating that the new suture devices are substantially equivalent to existing predicate devices (ExpressBraid Graft Manipulation and Arthrex Fiber Tape Suture) based on their intended use, indications for use, materials, design features, colorants, sterilization, and performance testing (knot tensile strength, needle attachment, biocompatibility, pyrogenicity, and shelf life).

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