Search Results

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.

K2M Navigation Instruments are nonsterile, reusable surgical instruments (inserters, taps, probes, and awls) and single use drill bits intended be used when implanting previously cleared components of Mesa, Denali, Everest, and Yukon Spine Systems. These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during cervical and thoracolumbar spinal surgery.

The provided text is a 510(k) summary for the K2M Navigation Instruments. It discusses the device's indications for use, its substantial equivalence to predicate devices, and the design validation testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, associated performance data, test set details (sample size, provenance, ground truth establishment, adjudication), training set details, or any multi-reader multi-case (MRMC) comparative effectiveness study.

The document states:

• "Design validation testing was conducted to ensure the K2M Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments."

This indicates that performance testing was done for the navigational instruments themselves, focusing on their functionality and compatibility with a navigation system, rather than evaluating the performance of an AI/ML algorithm that predicts or diagnoses. The device described, "K2M Navigation Instruments," appears to be physical surgical instruments (inserters, taps, probes, and awls) designed to work with a stereotactic navigation system (Medtronic StealthStation® System) to assist surgeons with screw placement. It is not an AI/ML powered diagnostic or predictive device.

Therefore, since the device is not an AI/ML system, the requested information regarding AI/ML acceptance criteria and study results (including AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set details, etc.) is not applicable to the content of this 510(k) summary.

Ask a specific question about this device