Search Results

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST) 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.

K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI and EVEREST Spinal Systems.

Function: These instruments are designed to interface with the Brainlab Navigation System when used for navigation during spinal surgery.

The provided text describes the regulatory clearance of the K2M Navigation Instruments, but it does not contain information about specific acceptance criteria or a detailed study proving the device meets them in the way typically expected for an AI/ML device or a diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance evaluation. This means the device's safety and effectiveness are established by showing it is as safe and effective as existing legally marketed devices, rather than through a detailed clinical trial with specific performance metrics and statistical analyses.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, MRMC studies, or standalone performance for this device based on the provided text.

Here's what I can extract regarding the performance evaluation:

1. A table of acceptance criteria and the reported device performance:

   • The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific dimensional tolerances with thresholds).
   • The reported performance is qualitative: "The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not specified. The evaluation was "Non-clinical Performance Evaluation," which likely involved laboratory testing rather than data from human patients.

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. As this was a non-clinical evaluation of surgical instruments, expert "ground truth" as understood in diagnostic AI studies is not relevant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for this type of non-clinical evaluation.

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. This device is a manual surgical instrument intended to interface with a navigation system, not an AI or diagnostic tool that assists human readers/interpreters. There is no mention of an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not explicitly stated. For "Dimensional comparisons and simulated use testing," the "ground truth" would likely be engineering specifications, physical measurements, and functional observations against defined requirements for compatibility and operation within the Brainlab Navigation System.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

Summary of relevant information from the text regarding performance evaluation:

• Evaluation Type: Non-clinical Performance Evaluation.
• Methods: Dimensional comparisons and simulated use testing.
• Purpose: To ensure functionality and compatibility with the Brainlab Navigation System.
• Conclusion: "The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices." This implies that the device met the implicit standards of functionality and compatibility demonstrated by the predicate devices.

Ask a specific question about this device