The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.

Device Description

The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.

The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the MaxAn® Anterior Cervical Plate System, based on the provided text:

Important Note: The provided document is a 510(k) summary for adding MR Conditional labeling to an already cleared device (MaxAn® Anterior Cervical Plate System). Therefore, the "study" described herein specifically pertains to MR compatibility, not the primary clinical effectiveness or safety of the spinal fixation itself, which would have been established in the original K080646 submission. The information below reflects what's available in this specific document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ASTM Standard)	Reported Device Performance (MaxAn® Anterior Cervical Plate System)
ASTM F2052-06 (Magnetically Induced Displacement Force on Medical Devices)	Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of magnetically induced displacement.
ASTM F2119-07 (Evaluation and Labeling of MR Image Artifacts)	Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of MRI artifacts.
ASTM F2182-11a (Heating of Medical Devices During MRI)	Test results indicate that the device meets the ASTM recommendations for MR Conditional labeling in terms of device heating.
ASTM F1717-04 (Static & Dynamic Testing of Spinal Constructs)	Qualitative torque testing was presented. (The document states these tests were conducted, implying performance met standards, but specific quantified acceptance criteria and performance values are not detailed in this summary for these mechanical tests).
Static compression bending	(Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.)
Static torsion	(Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.)
Dynamic compression	(Implied to meet ASTM F1717-04 recommendations, but specific criteria/results not detailed.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in this 510(k) summary. The document refers to "testing conducted" according to ASTM standards, which would imply a number of device samples were used for each test. Specific quantities are not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing described is bench testing (mechanical and MR compatibility), not human or animal studies, so "retrospective or prospective" is not applicable in the typical clinical sense. The tests were performed to evaluate the physical properties of the device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the "ground truth" for these tests is the direct measurement of physical properties against established ASTM standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and technicians executing the tests and interpreting the raw data, but their number and specific qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

This is not applicable. As these are bench tests measuring physical properties, there is no "adjudication method" in the sense of reconciling differing expert opinions. The outcome is determined by whether the measured physical property (e.g., heating, displacement) falls within the acceptable limits defined by the ASTM standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in this document. This submission pertains to MR Conditional labeling for a device, which involves bench testing, not clinical performance comparison with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical spinal implant, not an algorithm or AI system. The testing performed is to assess the physical device's compatibility with an MRI environment.

7. Type of Ground Truth Used

The "ground truth" used for these tests is the objective measurements of physical forces, temperatures, and image artifacts as defined and evaluated against the specified ASTM (American Society for Testing and Materials) standards. These standards provide the accepted methodology and limits for determining MR compatibility and mechanical performance.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

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

November 5, 2014

Mr. Spencer Kimber Regulatory Affairs Specialist Biomet Spine, LLC 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

Re: K133518

Trade/Device Name: MaxAn® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 3, 2014 Received: October 6, 2014

Dear Mr. Kimber:

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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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 yours,

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

K133518 510(k) Number (if known):

Device Name: MaxAn® Anterior Cervical Plate System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of Orthopedic Devices 510(k) Number: K133518

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Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter enclosed in a rectangular box. Below "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	October 3, 2014
Applicant/Sponsor:	Biomet Spine399 Jefferson RoadParsippany, NJ 07054
Contact Person:	Spencer KimberRegulatory Affairs SpecialistPhone: 303-501-8523Fax: 303-501-8444
Trade name:	MaxAn® Anterior Cervical Plate System
Common Name:	Spinal Intervertebral Body Fixation Orthosis
Classification Name(Product Code):	Appliance, Fixation, Spinal Intervertebral Body (KWQ)
Device Panel - RegulationNo.:	Orthopedic - 21 CFR 888.3060
Primary Predicate:	K080646

Device Description:

The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.

Indications for Use:

The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.

Summary of Technologies:

The technological characteristics of the MaxAn Anterior Cervical Plate System are unchanged from its original clearance in K080646 in regards to intended use, indications, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles.

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Performance Data:

MR compatibility testing was conducted according to the following ASTM standards:

ASTM F2052-06
ASTM F2119-07 ●
ASTM F2182-11a

Qualitative torque testing was presented.

Static compression bending, static torsion and dynamic compression tests were conducted according to ASTM F1717-04 Spinal Constructs in a Vertebrectomy Model.

Test results indicate that the MaxAn Cervical Plate System meets the ASTM recommendations for MR Conditional labeling in terms of device heating, magnetically induced displacement and MRI artifacts.

Substantial Equivalence:

The addition of MR Conditional Labeling does not alter the substantial equivalence of the MaxAn Cervical Plate System, which was previously cleared in K080646.

Conclusion:

The non-clinical testing provided in this submission supports the addition of MR Conditional labeling for the MaxAn Cervical Plate System. Based upon the testing provided, and the additional labeling, the subject device is as safe and effective as the predicate device.

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.