(134 days)
The Injectable Mimix™ is a self-setting calcium phosphate cement intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The bone filler is not intended for percutaneous injection use.
The Injectable Mimix™ is packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively and then inserted into a syringe style pipet that will be used to apply the filler to bone gaps or defects. The bone filler is indicated for the augmentation or restoration of bony contour in the craniofacial skeleton. The bone filler is not intended for percutaneous injection use. The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate (Na3CgH3O7 2H2O). The liquid component is a solution comprised of anhydrous citric acid (CoHsO7) and distilled water (H2O).
The provided text is a 510(k) summary submission for the "Injectable Mimix™" device and primarily focuses on establishing substantial equivalence to a predicate device. It states that "Non-clinical testing demonstrated statistical equivalence between this device and the predicate" and "Clinical testing was not used to establish substantial equivalence." This means that the submission did not perform a study directly evaluating the device against acceptance criteria in the manner described in your request.
Therefore, I cannot fill in the requested table and sections as no such study with specified acceptance criteria, sample sizes, expert involvement, or ground truth establishment was conducted for this submission. The basis of approval here was through non-clinical testing demonstrating equivalence to an already legally marketed device, not through a direct performance study meeting specific clinical or device performance metrics.
In summary, based on the provided document, there is no information available to complete the requested sections.
§ 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).