K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

Device Description

The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates to the system. The Pyrenees system components are provided non-sterile.

AI/ML Overview

The provided document describes the K2M Pyrenees Cervical Plate System, a spinal fixation device, and its substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a specific study that quantitatively proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving AI or diagnostic devices.

The document focuses on the regulatory clearance for a physical medical device (cervical plate system) based on material, design, function, and mechanical performance rather than a diagnostic algorithm or AI system. Therefore, most of the requested fields are not applicable to the information contained in this document.

Here's a breakdown of the available information and why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., benchmark for mechanical strength)	Reported Device Performance
Static compression performance in accordance with ASTM F1717	Performed equally to or better than predicate devices
Static torsion performance in accordance with ASTM F1717	Performed equally to or better than predicate devices
Dynamic compression performance in accordance with ASTM F1717	Performed equally to or better than predicate devices

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. The testing involved mechanical measurements on plate samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not expert human assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.

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. No AI or human reader component is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the mechanical performance of the Pyrenees Cervical Plate System was established by adherence to ASTM F1717 standards for static and dynamic mechanical properties.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing as described. Product development iterations might involve prototypes, but it's not a "training set" as understood in AI/ML.

9. How the ground truth for the training set was established: Not applicable. No training set in the AI/ML sense exists.

Summary of available information from the document:

Device Type: Pyrenees Cervical Plate System (spinal intervertebral body fixation orthosis).
Purpose: Anterior screw fixation to the cervical spine (C2-C7).
Indications for Use: Degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, failed previous fusions (pseudarthrosis), and deformity.
Materials: Titanium alloy per ASTM F1472 and CP titanium per ASTM F67.
Testing Performed: Non-clinical mechanical performance evaluation.
Standards Used: ASTM F1717 (for static compression, static torsion, and dynamic compression).
Conclusion of Testing: The plates performed equally to or better than predicate devices in the specified mechanical tests.
Regulatory Status: Substantially equivalent to legally marketed predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

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

September 4, 2015

K2M, Incorporated Ms. Nancv Giezen Manager Regulatory Affairs 751 Miller Drive Southeast Leesburg, Virginia 20175

Re: K152015

Trade/Device Name: Pyrenees Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 20, 2015 Received: July 21, 2015

Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Nancy Giezen

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.

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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.

Mark N. Melkerson -S

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)

K152015

Device Name Pyrenees Cervical Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Pyrenees Cervical Plate System

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 07/20/2015

Classification

Pyrenees Cervical Plate System Trade Name: Common Name: Spinal Fixation System Regulatory Class: Class II

Classification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code KWQ)

Predicate Device(s)

Primary Predicate: K2M Pyrenees Cervical Plate System (K063544) Additional Predicates: K2M Pyrenees Cervical Plate System (K150983)

Device Description

The Pvrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates to the system. The Pyrenees system components are provided non-sterile.

Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.

Intended Use

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Technological Comparison to Predicate(s)

The Pyrenees Cervical Plate System was compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

The Pyrenees plates were mechanically tested and compared to predicate devices. The plates performed equally to or better than these systems in static compression, static torsion, and dynamic compression in accordance with ASTM F1717.

Conclusion

There are no significant differences between the Pyrenees Cervical Plate System 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

N/A