(45 days)
Callos CMF Bone Void Filler is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Callos CMF Bone Void Filler may be used in the restoration or augmentation of bony contours of the craniofacial skeleton, including fronto-orbital, malar, and mental areas.
Callos CMF Bone Void Filler is an impactable and moldable single use, biocompatible calcium phosphate bone void filler, that remodels and is replaced by bone during the healing process. Callos CMF is packaged in various kit sizes (3cc, 5cc, and 10cc).
This submission is for a medical device (Callos CMF Bone Void Filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (such as sample sizes for test/training sets, ground truth establishment methods, number of experts, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable and are not present in the provided 510(k) summary.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, technology, and product specifications for a bone void filler product. It does not involve any form of AI for image analysis or diagnostic support.
§ 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).