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Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).

The Smith & Nephew Image Guided Instruments for Hip Applications are instruments that have been modified to allow image-guided arrays (Fighters) to be fixed onto the instruments. The image-guided arrays can use either infrared LEDs (light emitting diodes) or universal passive spheres to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Along with commercially available software, this will allow the instruments to be recognized and tracked in real time in the surgical field. The infrared LEDs (light emitting diodes) or universal passive spheres do not come in contact with the open wound during surgical procedures. The image-guided arrays that are affixed to the instruments work in conjunction with reference frames that are rigidly attached to the anatomy. Each reference frame is also fitted with either infrared LEDs (light emitting diodes) or universal passive spheres to transmit or reflect the infrared LEDs (light emitting diodes) that are emitted by the IGS Platform System. The reference frames will allow the IGS Platform System to continuously track the position of the anatomy during navigation. If any movement of the IGS Platform System or anatomy is detected, the system can compensate for it, thereby maintaining accurate navigation.

The provided document is a 510(k) summary for the "Smith & Nephew Image Guided Surgical Instruments for Hip Applications." This document confirms the FDA's clearance of the device due to its substantial equivalence to predicate devices. However, it does NOT contain the detailed information necessary to complete the requested table and study information.

Specifically, the document does not describe any specific acceptance criteria or a study proving the device meets those criteria. It primarily focuses on the device description, its intended use, a list of predicate devices, and the FDA's clearance letter.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically establishes substantial equivalence, which often relies on a comparison to predicate devices, rather than presenting detailed performance studies with acceptance criteria for the new device itself.

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