(90 days)
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.
Not Found
The provided document is a 510(k) summary for a medical device (Norapad Cottonoid) and does not contain information regarding an AI/ML study. It is a premarket notification for a traditional medical device, comparing it to a predicate device for substantial equivalence, focusing on its intended use, materials, and manufacturing.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone), or ground truth, as these concepts are not applicable to the content of this 510(k) submission.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).