(25 days)
Mimix™ MP Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:
- Repair of neurosurgical burr holes
- Craniotomy cuts and other cranial defects
- Augmentation or restoration of bony contour in the craniofacial skeleton area no larger than 25cm².
The Mimix™ MP Bone Void Filler is packaged as separate, pre-measured powder and liquid components. These are intended to be mixed intraoperatively to produce a homogenous paste, which then sets into a hard, porous material. Because of its apatitic nature, the material is highly biocompatible. The powder component is a mixture of a ceramic calcium phosphate powder and sodium phosphate. The liquid component is a solution comprised of anhydrous citric acid (C6H8O7) and water (H2O).
The provided text is a 510(k) summary for the "Mimix™ MP Bone Void Filler" and explicitly states:
"Clinical Testing: Clinical testing was not used to establish substantial equivalence."
Therefore, a study demonstrating the device meets acceptance criteria was not performed for this submission. The 510(k) relies on substantial equivalence to a predicate device (Mimix™ Bone Void Filler K990290) based on non-clinical testing.
As such, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for a clinical study that did not occur.
§ 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).