Search Results

MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.

The device of this submission is a material formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR® Surgical Implant Material.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for a medical device (MEDPOR® Plus Surgical Biomaterial), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal performance studies with acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details from the given text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the approval is based on substantial equivalence, not necessarily on a detailed performance study against predefined acceptance criteria for the new device.

Ask a specific question about this device