(119 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 include inserters, taps, probes and awls intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems.
Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.
The provided text is a 510(k) summary for the "Brainlab Compatible K2M Navigation Instruments." This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study of the device's performance against specific acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device.
Therefore, many of the requested details, such as specific performance metrics (sensitivity, specificity, AUC), sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, are not applicable and not present in this type of regulatory submission. The device described is a set of surgical instruments used with a navigation system, not an AI or algorithmic device that performs independent analysis or diagnosis.
Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations for the requested information format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality and compatibility with the Brainlab Navigation System | "Simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System." |
| "In addition, testing met the acceptance criteria established by Brainlab for these devices." | |
| Equivalence to predicate devices in design, function, material, and intended use | "The results of these evaluations confirmed that the Brainlab Compatible K2M Navigation Instruments are equivalent to predicate devices." |
| "There are no significant differences between the Brainlab Compatible K2M Navigation Instruments and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." | |
| Dimensional comparisons | "Dimensional comparisons... was performed to ensure functionality and compatibility..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document describes "simulated use testing" and "dimensional comparisons" for surgical instruments, not a test set of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable / Not provided. Ground truth in the context of an algorithm's performance is not relevant for this type of device (surgical instruments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable / Not provided. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable / Not provided. This device is surgical instrumentation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would refer to its physical properties (dimensions) and its ability to mechanically interface with the Brainlab Navigation System as intended. The acceptance criteria were established by Brainlab.
8. The sample size for the training set
Not applicable / Not provided. There is no algorithm or training set mentioned.
9. How the ground truth for the training set was established
Not applicable / Not provided. There is no algorithm or training set mentioned.
§ 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).