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The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed or use in the The Flora Somes Offication and aspiration of soft tissues as used in the following surgical areas:

NEUROSURGERY
For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following:
Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors.

GASTROENTEROLOGY
Various Gastroenterological and General surgery procedures along the GI tract , which may include, but are not necessarily limited to the following:
Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal turnor

ORTHOPEDICS
Various orthopedic procedures which may include, but are not necessarily limited to the following:
Discectomy

Fibra Sonics Ultrasonic Surgical Aspirator Model 1000

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Fibra-Sonics, Incorporated regarding their Ultrasonic Surgical Aspirator System Model 1000. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the general regulatory requirements.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details typically found in a study report proving a device meets acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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