The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), 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 is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through material and functional comparisons, not on efficacy studies involving AI or complex statistical analysis of diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and expert evaluation is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

This type of information (specific performance metrics for AI, such as sensitivity, specificity, or AUC) is not applicable to this medical device submission. The submission is for a spinal fixation system, not a diagnostic AI tool.

Acceptance Criteria	Reported Device Performance
Material Composition	Meets ASTM and ISO standards for Commercially Pure titanium and titanium alloy.
Functionality	Functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
Substantial Equivalence	Demonstrated to be substantially equivalent to current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592) in design, function, material, and intended use.
Mechanical Testing	Testing in accordance with ASTM F1717 was performed. (Specific results or acceptance thresholds are not detailed in this summary.)

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

Not applicable. This is a submission for a physical medical device (cervical plate system), not an AI diagnostic tool that uses datasets. The "testing" mentioned refers to mechanical and material compliance testing, not clinical studies with patient data in the context of an AI algorithm.

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):

Not applicable. There is no "ground truth" in the AI diagnostic sense for a cervical plate system. The ground truth for this device would be established through engineering specifications, material science, and possibly in-vitro mechanical testing.

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

Not applicable. This relates to expert review of AI diagnostic outcomes, which is not relevant for this device.

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. This device is not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

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

Not applicable. This device is a physical implant, not an algorithm.

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

For this type of device, the "ground truth" is primarily engineering and material specifications, and performance against established standards (e.g., ASTM F1717 for mechanical properties). Clinical outcomes would be observed post-market but are not part of this 510(k) summary for substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the AI sense for this device.

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

Not applicable. There is no AI training set.

Summary

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K063544

FFB 1 4 2007

510(k) Summary Pyrenees Cervical Plate System K2M, Inc.

This safety and effectiveness summary for the Pyrenees Cervical Plate System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter :

K2M, Inc. 751 Miller Drive SE Suite F 1 Leesburg, VA 20175

Contact Person :

Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155

Date Prepared: November 21, 2006

2. Tradename: Pyrenees Cervical Plate System Common Name: Anterior Cervical Plate Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) Classification Name:

3. Description of the device:

Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

4. Intended Use:

The Pvrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications : degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

5. Predicate or legally marketed devices which are substantially equivalent:

Testing in accordance with ASTM F1717 was performed and demonstrated that the modified Pyrenees Cervical Plate System is substantially equivalent to the current cleared Pyrenees Cervical Plate (K060442), Synthes CSLP (K971883, K000538), K2M, Inc. Tectonic Anterior Cervical Plate System (K051531), De Puy Acromed PEAK Cervical Plate System (K971730, K926486) and the Interpore Cross Anterior Cervical Plate System (K002592).

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K2M, Limited Liability Company c/o Mr. Richard Woods Senior Vice President 751 Miller Drive, SE, Suite F-1 Leesburg, Virginia 20175

FFB 1 4 7007

Re: K063544

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: KWO Dated: November 21, 2006 Received: November 28, 2006

Dear Mr. Woods:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): K063544

Pyrenees Cervical Plate System Device Name :

Indications For Use :

Prescription use >> OR

Over-the-counter use ( PER 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )

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Concurrence of CDRH, Office of Device Evaluation ( ODE )

Division Sign-Of

(Division Sign-Off) Division of General, Restorative, and Neurological I

510(k) Number

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.