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.

Device Description

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.

AI/ML Overview

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:

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."
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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of non-clinical evaluation.
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.
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.
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.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

K2M Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175

Re: K171556

Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 14, 2017 Received: December 18, 2017

Dear Nancy Giezen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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K171556

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) SUMMARY K2M Navigation Instruments

Submitter

K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 12/14/2017

Classification

Trade Name: K2M Navigation Instruments Common Name: Navigation Instrument Regulatory Class: Class II

Classification Name(s): Stereotaxic instrument (21 CFR 882.4560, Product Code OLO)

Predicate Device(s)

Primary Predicate: Brainlab Spine and Trauma (K083310) Additional Predicates: DePuy VIPER® and EXPEDIUM® navigated instruments (K120867) Range/Mesa/Denali Spinal System (K171832) Everest Spinal System (K161369)

Device Description

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.

Intended Use

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Technological Comparison to Predicate(s)

K2M Navigation Instruments were compared to predicate devices and the design features, materials and indications were the same or similar to the previously cleared devices.

Non-clinical Performance Evaluation

Dimensional comparisons and simulated use testing was performed to ensure functionality and compatibility with the Brainlab Navigation System. The results of these evaluations determined that the K2M Navigation Instruments are equivalent to predicate devices.

Conclusion

There are no significant differences between the 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.

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Indications for Use

510(k) Number (if known) K171556

Device Name

K2M Navigation Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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).