(391 days)
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.
Sevrain Cranial Clamp 200 Series (Polyethylene)
I am sorry, but this document is an FDA 510(k) clearance letter for a medical device called the "Sevrain Cranial Clamp 200 Series." This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies or data used to reach this determination.
Therefore, I cannot provide the requested information from 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).