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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.

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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.

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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

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.

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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.

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K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALI, MESA, EVEREST) 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. The K2M Navigation 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 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 Medtronic StealthStation® System when used for navigation during spinal surgery.

The provided text describes a 510(k) premarket notification for K2M Navigation Instruments. However, it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study that proves the device meets those criteria.

Here's what can be extracted and what is missing:

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

The document broadly states:

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

This information is not provided in the document. The document only mentions "testing was performed."

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)

This information is not provided in the document. The type of device (surgical navigation instruments) suggests the "ground truth" might relate to physical measurements or engineering specifications, rather than clinical expert consensus on images.

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

This information is not provided in the document.

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

There is no indication of an MRMC study or AI assistance in this document. The device is described as "manual surgical instruments" and its function is to "interface with the Medtronic StealthStation® System when used for navigation." This implies it's a tool for surgeons during a procedure, not an AI-powered diagnostic system requiring human reader studies.

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

This information is not provided. Given it's a physical instrument, the concept of "standalone algorithm performance" as typically applied to AI/software might not directly apply in the same way. The performance would be related to its physical properties and its interaction with the navigation system.

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

The document does not explicitly state the type of ground truth. However, given the nature of the device (navigation instruments for surgery), the "ground truth" for "rigidity, registration, and accuracy testing" would likely involve:

• Engineering specifications and measurements: Comparing the instrument's performance to pre-defined physical tolerances and established accuracy benchmarks for navigated surgical systems.
• Physical compatibility testing: Ensuring the instrument physically and digitally integrates correctly with the Medtronic StealthStation System.

8. The sample size for the training set

This information is not provided. The device is an instrument, not an AI/ML algorithm that typically has a "training set."

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

This information is not provided. (See explanation for point 8).

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance evaluations of physical properties like rigidity, registration, and accuracy. It lacks the detailed study design, participant numbers, and outcome metrics that would be present in a comprehensive clinical or performance study report for an AI/ML or diagnostic device.

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