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Easy Whip™ is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.

EasyWhip™ is a non-absorbable suture with specialized needle that simplifies and standardizes existing manual suturing methods as a convenience to surgeons. It is designed to facilitate easy, fast, and accurate stitch placement with less variation. EasyWhip™ is versatile and enables several stitch techniques or patterns, including a whip stitch, a WhipLock™ stitch (which combines a whip stitch with a locking stitch similar to a Krakow stitch), and custom patterns according to individual user needs and preferences.
EasyWhip™ consists of a single USP size 2, braided 40" strand of suture (20" loop) with portions of a two-part needle attached to each end. The needle portions consist of a tip with a sharp point and a dull insert that slides within the needle tip during stitching. The suture is non-absorbable Ultra-High Molecular Weight Polyethylene (UHMWPE) dyed black (D&C Black #4 not to exceed 1.0% by weight). The device is provided sterile for single use only. EasyWhip™ meets all surgical suture requirements established by USP for non-absorbable surgical sutures, except for oversize diameter.

This document is a 510(k) Premarket Notification from the FDA for a medical device called EasyWhip™. It is not a document describing an AI/ML device that requires acceptance criteria for AI performance. Therefore, I cannot extract the information requested as it pertains to AI/ML device performance.

The document discusses a surgical suture and its needle, focusing on its physical properties, biocompatibility, and substantial equivalence to a predicate device. The testing described is primarily mechanical, biological, and stability testing for this type of medical device, not AI/ML performance evaluation.

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