(90 days)
BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.
This document is a 510(k) premarket notification for a medical device called Bonesource® HAC Fast Setting Cement. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The provided text describes a traditional medical device (hydroxyapatite cement) and its substantial equivalence to previously marketed devices. There are no mentions of an algorithm, AI, machine learning, or any performance metrics like sensitivity, specificity, or AUC, nor any study conducted on such a system.
Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided input does not pertain to an AI/ML device.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).