(404 days)
This device is intended for use as the principle regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "CRX DIAMOND VALVE." It confirms that the device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).