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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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The Navitrack™ System - Total Hip Replacement CT-Free Cup is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

The Navitrack™ System - Total Hip Replacement CT-Free Cup device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.

The provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free Cup, focusing on demonstrating substantial equivalence to a predicate device.

Specifically, the "Performance Data" section states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate as compared to the predicate." This indicates that some form of comparison was done, but no specific acceptance criteria, study design, or performance metrics are detailed.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study to prove they are met. The information is simply not present in the provided text.

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