(61 days)
Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.
This document is a 510(k) submission for Porous HDPE Surgical Implants (K022665). It establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as this document describes a traditional medical device (surgical implants) and not an AI/ML powered device.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.