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 radios ), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scollosis, 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 in accordance with ASTM F1472 and 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 and screws to the system. The Pvrenees system components are provided non-sterile.

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

AI/ML Overview

The provided text describes the Pyrenees Cervical Plate System, a medical device for spinal fixation, and its substantial equivalence determination by the FDA. However, the document does not contain details about acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way your request outlines (e.g., in terms of sensitivity, specificity, or AI-assisted improvements).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for a novel technology (like an AI device).

Therefore, I cannot provide the requested information from the given text. The text primarily addresses:

Device Description: The Pyrenees Cervical Plate System consists of titanium plates and screws for anterior cervical spine fixation (C2-C7).
Indications for Use: Degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, tumors, failed previous fusions, and deformity.
Predicate Devices: K2M Pyrenees Cervical Plate System (K063544, K092474, K111135), DePuy Uniplate (K042544), and Synthes CSLP (K003043).
Non-clinical Performance Evaluation: The subject Pyrenees plates did not create a new worst-case compared to predicate devices. Predicate plates performed equally to or better than these systems in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. This section confirms mechanical performance, but not against AI-related acceptance criteria.
Conclusion: The device is substantially equivalent to other marketed devices in design, function, material, and intended use.

In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria, study details for meeting those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device.

Summary

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

May 1, 2015

K2M, Incorporated % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Leesburg, Virginia 20175

Re: K142212

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: April 3, 2015 Received: April 6, 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)

K142212

Device Name Pyrenees Cervical Plate System

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: 04/02/2015

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 (K092474, K111135) DePuy Uniplate (K042544) Synthes CSLP (K003043)

Device Description

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

Intended Use

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).

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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 subject Pyrenees plates did not create a new worst case compared to predicate devices. The predicate 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

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.