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 F136 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 and screws 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

Analysis of Acceptance Criteria and Study Information

The document describes a medical device, the "Pyrenees Cervical Plate System," and its submission for FDA 510(k) clearance. A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than fulfilling specific acceptance criteria in the way a new drug trial or an AI algorithm validation might.

The "study" described here is a non-clinical performance evaluation focusing on mechanical testing, a common requirement for orthopedic implants.

Here's a breakdown of the requested information based on the provided text:

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

For a mechanical device like this, "acceptance criteria" are typically related to meeting specific performance benchmarks established by recognized ASTM standards or demonstrating equivalence to predicate devices. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Performance equal to or better than predicate devices in static compression per ASTM F1717	Performed equally to or better than predicate systems in static compression
Performance equal to or better than predicate devices in static torsion per ASTM F1717	Performed equally to or better than predicate systems in static torsion
Performance equal to or better than predicate devices in dynamic compression per ASTM F1717	Performed equally to or better than predicate systems in dynamic compression

Note: The document doesn't explicitly state quantitative acceptance values (e.g., minimum load strength). Instead, the performance is reported relative to the predicate devices, which is typical for 510(k) mechanical testing. The ASTM F1717 standard itself establishes methodologies for such testing.

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

Sample Size for Test Set: The document does not specify the exact number of plates or screws tested. It refers to "the Pyrenees plates" being "mechanically tested," implying a representative sample.
Data Provenance: Not explicitly stated, but mechanical testing of medical devices is typically conducted in controlled laboratory settings, often by the manufacturer or a third-party testing facility. This is a non-clinical, prospective test in a laboratory environment. There is no patient data involved.

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)

Experts: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is established through physical measurement and adherence to engineering standards (like ASTM F1717). No human experts are involved in "diagnosing" or "interpreting" the mechanical performance, beyond engineers conducting and analyzing the tests.

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

Adjudication Method: Not applicable. This is mechanical testing, not a clinical trial involving human interpretation.

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

MRMC Study: No. This document is for a physical medical device (cervical plate system), not an AI/software as a medical device. Therefore, MRMC studies and concepts of human readers or AI assistance are not relevant.

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

Standalone Performance: No. This is a physical implant, not an algorithm.

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

Type of Ground Truth: The "ground truth" here is the physical mechanical properties of the device, measured quantitatively according to established engineering standards (ASTM F1717) and compared against the mechanical properties of predicate devices. There is no biological, clinical, or consensus-based ground truth in this context.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. There is no concept of a "training set" for a physical implant.

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

Ground Truth for Training Set: Not applicable. As above, there is no training set.

Summary

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

July 14, 2015

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

Re: K150983

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: June 16, 2015 Received: June 17, 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 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) K150983

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: 06/16/2015

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: DePuy Uniplate (K042544) Synthes CSLP (K971883, K000536) EBI Cyprus (K060379) DePuy Peak (K971730)

Device Description

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

§ 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.