(28 days)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and /or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above).
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
This document, K193547, is a 510(k) premarket notification decision letter for the "CustomizedBone Service" device. It is not an imaging AI device, but rather a preformed nonalterable cranioplasty plate. As such, the information you've requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies) is not present in this document.
The document primarily focuses on the FDA's determination of substantial equivalence for this medical device to existing predicate devices, its intended use, and regulatory compliance.
Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI/ML device based on this specific input.
§ 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).