(31 days)
The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Longeviti PMMA Static Cranial Implant, indicating substantial equivalence to a predicate device. It defines the device’s indications for use but does not contain any information regarding acceptance criteria, study details, or device performance metrics.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is typically found in the 510(k) submission summary or a separate clinical study report, which is not part of this document.
§ 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).