(288 days)
This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.
This document is a 510(k) summary for a neurological surgical sponge, and it explicitly states that "Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices."
Therefore, a study demonstrating that the device meets specific acceptance criteria, as requested in the prompt, was not performed, nor was it required for this submission. The basis for clearance is substantial equivalence to a legally marketed predicate device (K904519), and since no significant technological differences were identified, performance testing was deemed unnecessary by the manufacturer for this submission.
As a result, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as such information is not present in the provided text.
§ 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).