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.

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 Medtronic StealthStation® System when used for navigation during spinal surgery.

AI/ML Overview

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:

Acceptance Criteria Category	Device Performance
Rigidity	Not specified in detail, but "Rigidity... testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices."
Registration	Not specified in detail, but "Registration... testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices."
Accuracy	Not specified in detail, but "Accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation." The conclusion states it is "equivalent to predicate devices."
Functionality (with Medtronic StealthStation)	"Testing determined that the K2M Navigation Instruments are equivalent to predicate devices."
Compatibility (with Medtronic StealthStation)	"Testing 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)

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.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 30, 2017

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

Re: K171321

Trade/Device Name: K2M Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 31, 2017 Received: August 1, 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, listing 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Katherine D. Kavlock -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171321

Device Name K2M Navigation Instruments

Indications for Use (Describe)

K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (DENALL 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 Medronic 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

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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510(k) SUMMARY K2M Navigation Instruments

Submitter

K2M 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 7/26/2017

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: Medtronic Navigated Instruments (K143375) Additional Predicates: Medtronic Medtronic Navigated Instruments (K143628, K143375) K2M Range/Mesa/Denali Spinal System (K070229, K153031) K2M Everest Spinal System (K103440, 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 Medtronic StealthStation® System when used for navigation during spinal surgery.

Intended Use

Technological Comparison to Predicate(s)

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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

Rigidity, registration, and accuracy testing was performed to ensure functionality and compatibility with the Medtronic StealthStation. The results of testing 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.

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).