(133 days)
The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.
The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.
The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implant. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria for a study demonstrating device performance, nor details of a study that proves the device meets such criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
- Information on MRMC studies, standalone algorithm performance, or the type of ground truth used.
- Information regarding the training set's size or how its ground truth was established.
The document primarily focuses on the regulatory aspects of the device, establishing substantial equivalence to a predicate device, and outlining general controls and FDA regulations. It mentions that there are "no technological differences to the material (PMMA) and no differences to the materials of manufacturing. There are no differences to the packaging or sterilization process" compared to its predicate device (Longeviti ClearFit OTS Cranial Implant, K212058). This suggests that the substantial equivalence determination is based on the similarity of the device to previously cleared devices, rather than new performance data from a specific study demonstrating new acceptance criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The text does not contain that information.
§ 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).