(90 days)
The INVISx™ Burr Hole Lock is intended for use in covering burr holes and in refixation of cranial bone flaps following a craniotomy.
The INVISx™ Burr Hole Lock consists of a two piece polymer implant used to cover the burr hole(s) created during cranial surgery. INVISx™ Burr Hole Lock is packaged sterile and is intended for single (one-time) use only.
The provided document is a 510(k) summary for the Medtronic INVISx™ Burr Hole Lock. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Such information, particularly detailed performance data, sample sizes, expert qualifications, and ground truth methodologies, is typically found in the more comprehensive 510(k) submission itself, not in the publicly available summary. The summary focuses on demonstrating equivalence to an already approved predicate device based on materials, design, performance specifications, and intended use.
Therefore, I cannot populate the requested table and answer the specific questions based solely on the provided text. The document refers to "performance specifications" in the context of technological comparison, but it does not elaborate on what those specifications are or how they were met through a study.
§ 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).