(323 days)
The Osteopore PCL Scaffold™ Bone Filler is intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
The Osteopore PCL Scaffold™ is a bone void filler. The Shape of the Osteopore PCL Scaffold™ conforms to the defect, thus maximizing direct contact with viable host bone.
The provided text describes the Osteopore PCL Scaffold™ Bone Void Filler and its 510(k) clearance, but it does not contain the specific information requested about acceptance criteria, device performance tables, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document discusses the device description, intended use, and a summary of substantial equivalence to predicate devices. It mentions that the device was "evaluated for performance using a rabbit calvarial defect model," but it does not provide any detailed results, acceptance criteria, or a quantified "reported device performance" from this evaluation.
Therefore, I cannot populate the requested information from the provided text. The document focuses on demonstrating substantial equivalence rather than presenting detailed performance study results against specific acceptance criteria.
§ 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).