(110 days)
AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
AOC™ Porous Polyethylene Surgical Implants are provided as blocks, sheets, and anatomical shapes, and are manufactured of porous high-density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years. The implants are provided with a coating of a water-soluble alkylene oxide copolymer blend. AOC Porous Polyethylene Implants are provided sterile by irradiation and must not be resterilized.
The provided document is a 510(k) summary for the Ceremed, Inc. AOC Porous Polyethylene surgical implant. It focuses on establishing substantial equivalence to predicate devices and describes the device, its intended use, and regulatory classification.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, study design, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory submission for premarket notification, not a detailed technical performance study report.
§ 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.