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The Power Rasp is intended for use as an accessory to the XPS Straight Shot handpiece The Xomed XPS StraightShot Microdebrider System is intended for the cutting and removal of soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery. It is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is needed. These include open spinal surgeries and small and large joint arthroscopic procedures.

The Power Attachment for cutting blades / rasps is indicated for use with the XPS Straight Shot Microdebrider during surgical procedures to operate these various accessories to cut hard and soft tissue or bone in orthopedic and otorhinolaryngology and head and neck surgery. These include open spinal surgeries and small and large joint arthroscopic procedures.

The XPS Power Attachment is a mechanical attachment to the collet drive of the XPS Straight Shot handpiece that converts rotary motion to oscillating motion (forward and backward) to drive the cutting bit.

This document describes a 510(k) premarket notification for a medical device (Xomed FeatherTouch XPS Power Rasp Attachment), rather than a study proving a device meets acceptance criteria. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document focuses on regulatory approval based on substantial equivalence, not on performance studies with specific acceptance criteria.

The information provided includes:

• Device Name: Xomed FeatherTouch XPS Power Rasp Attachment
• Intended Use: Accessory to the XPS Straight Shot handpiece for cutting and removing soft and hard tissue or bone in otorhinolaryngology, head and neck, and orthopedic surgery (including open spinal surgeries and small and large joint arthroscopic procedures).
• Regulatory Status: Cleared as substantially equivalent to a predicate device.

To address your request, a different type of document, such as a clinical study report, a validation study report, or a performance testing report, would be needed.

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