(30 days)
Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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 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 Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.
Brainlab Compatible K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems. These instruments are designed to interface with the Brainlab Navigation system when used for navigation during spinal surgery. The subject instruments feature a modification of the connection mechanism geometry and material to enhance user experience.
The provided FDA 510(k) summary for the "Brainlab Compatible K2M Navigation Instruments" does not contain information typically found in a study proving a device meets specific acceptance criteria for performance, especially not in the context of an AI/algorithm-based medical device.
This document describes a conventional surgical instrument that interfaces with an existing navigation system. The "Non-clinical Performance Evaluation" section mentions a risk assessment and rotational testing, which are standard for mechanical devices. It does not refer to any clinical studies, AI performance metrics, or ground truth establishment as would be required for an AI/ML medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about MRMC studies. This is because the device in question is a surgical instrument and not an AI/ML-driven diagnostic or treatment planning system that would necessitate such detailed performance evaluation against ground truth.
The relevant sections state:
- Non-clinical Performance Evaluation: "A risk assessment including sterilization, biocompatibility, and additional rotational testing was conducted to confirm that the subject Brainlab Compatible K2M Navigation Instruments do not introduce new issues of safety or effectiveness."
- Conclusion: "There are no significant differences between the Brainlab Compatible K2M Navigation Instruments and other legally marketed systems. It is substantially equivalent to these other devices in design, function, material and intended use."
These statements indicate that the submission relies on demonstrating substantial equivalence to a predicate device through engineering and safety testing, rather than an AI performance study.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).