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The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

The LandmarX™ FrameLock™ kit is an optional accessory of the LandmarX Image Guided Surgical System, previously cleared in K992927. The LandmarX™ FrameLock™ kit is designed to provide a safe, reliable, compact, and minimally invasive means of direct and rigid fixation to the patient's skull for the LandmarX™ reference arc (REF # 960-632). The FrameLock™ mounts using a titanium screw entering a pilot hole drilled with stainless steel manual drill and accessories. A small percutaneous incision is adequate to install the device. The FrameLock also permits navigation using the sterile drape technique.

The provided document is a 510(k) premarket notification for a medical device (FrameLock Kit) and does not describe a study involving acceptance criteria for an AI/algorithm. Instead, it details the device's classification, description, indications for use, and a statement of substantial equivalence to previously marketed predicate devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not present in the provided text. This document is focused on regulatory clearance based on substantial equivalence, not the performance evaluation of an AI-powered device against specific acceptance criteria.

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