(101 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 tumours:
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary for the "CustomizedBone Service" does not contain information about the acceptance criteria and the study that proves the device meets those criteria.
The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses the regulatory classification, general controls, and compliance requirements for the device.
To address your request, information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and specific performance metrics would typically be found in the 510(k) Summary or 510(k) Premarket Notification itself, specifically in sections detailing the non-clinical and clinical performance data submitted to the FDA. The provided text is the FDA's response letter rather than the detailed submission from the manufacturer.
Therefore, I cannot extract the requested information from the given text.
§ 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).