Search Results

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Placement of Iliosacral Screws
Femoral Revision
Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts, their qualifications, and adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used, training set sample size, and how training set ground truth was established.

The document is a 510(k) premarket notification for the "Imageless Hip Module for the StealthStation® System." It states that the device is substantially equivalent to a predicate device (Hip Module for the StealthStation® System, K021980) based on accuracy testing provided in the filing and a risk analysis. However, the specifics of this accuracy testing are not described in the provided text.

The text focuses on the device's description, classification, and indications for use, and the FDA's determination of substantial equivalence. It confirms that "all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence," but does not elaborate on these activities or their outcomes in a way that would answer the specific questions posed.

Ask a specific question about this device