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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 based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).

Subject of this Premarket Notification are the Smith & Nephew Image Guided Surgical Instruments for Hip Applications for use on the BrainLAB VectorVision? Hip Navigation System. Along with the associated hip software, the image guided surgical instruments for hip applications can be recognized and tracked in real time in the surgical field. Smith & Nephew has previously received clearance for Image-Guided Instruments and Software for Hip Applications under K021798 for use on the Medironic Surgical Navigation Technologies SteathStation® Platform Systems. The Smith & Nephew Image Guided Surgical Instruments for Hip Applications have been developed in order to utilize the intra-operative image-guided technology to track the immediate location and position of the surgical instruments during surgical hip procedures using the BrainLAB VectorVision2 Hip Navigation System.

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with the specific elements requested.

This 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices for Smith & Nephew Image-Guided Surgical Instruments for Hip Applications. It lists predicate devices and reiterates the indications for use, but it does not present new performance data or acceptance criteria for this specific submission.

Therefore, I cannot provide the requested table and study details based on the input document. The document essentially states that the device uses the same fundamental scientific technology as the listed predicate devices and that the indications for use have not changed. This implies that the performance expectations would be similar to those of the predicate devices.

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