(278 days)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children above 13 years of age).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- · removal of tumors;
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Not Found
This document is a 510(k) clearance letter for the "CustomizedBone Service," a preformed nonalterable cranioplasty plate. The letter itself does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary. It confirms the device's substantial equivalence to predicate devices.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them from the provided text.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on a demonstration of substantial equivalence, which often relies on comparison to a legally marketed predicate device rather than on new extensive clinical trials for performance acceptance criteria in the same way a PMA or a de novo device might.
To provide the requested information, I would need access to the actual 510(k) submission summary or detailed study reports from the manufacturer, which are not present in this regulatory clearance letter.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).