The UNIFY™ Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Device Description

The UNIFY™ Dynamic Anterior Cervical Plate System consists of plates and variable or fixed angle screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7). The plate allows translation to accommodate bone graft resorption. UNIFY™ Dynamic Anterior Cervical Plate System implants are manufactured from titanium alloy, as specified in ASTM standards F136 and F1295.

AI/ML Overview

This document describes the UNIFY™ Dynamic Anterior Cervical Plate System, a modified anterior cervical plate system intended for spinal fixation. The provided text outlines the device's indications for use, technological characteristics, and basis for substantial equivalence to predicate devices. However, the document does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, many of the requested fields cannot be populated from the provided text, as they pertain to aspects of AI/ML model evaluation that are not relevant to this type of device submission.

Here's the breakdown based on the provided text, and an explanation of why certain fields cannot be filled:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for UNIFY™ Dynamic Anterior Cervical Plate System

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Meet ASTM F1717 standards and "Guidance for Spinal System 510(k)s" requirements for static and dynamic compression, static torsion, and static tension.	Performance data demonstrate substantial equivalence to the predicate device.
Material Composition	Conform to ASTM standards F136 and F1295 for titanium alloy.	Implants manufactured from titanium alloy, as specified in ASTM F136 and F1295.
Design/Dimensions/Intended Use	Similar to predicate devices.	Technological characteristics are similar to predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Explanation: The "acceptance criteria" for this traditional medical device (a spinal plate system) are implicitly met by demonstrating "substantial equivalence" to legally marketed predicate devices through adherence to mechanical testing standards and material specifications. There are no explicit numerical performance metrics like accuracy, sensitivity, or specificity, as those are typical for diagnostic or AI-driven devices.

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 submission is for a physical medical device (spinal plate), not an AI/ML system that uses a test set of data. The performance testing refers to mechanical laboratory tests, not data analysis.

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. This submission is for a physical medical device. "Ground truth" in the context of expert review is not relevant here. The "ground truth" for mechanical testing would be the physical properties and performance of the device under controlled laboratory conditions, as defined by ASTM standards.

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

Not applicable. As above, this is for a physical medical device and not an AI/ML system requiring expert adjudication of a test set.

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 is for a physical medical device. MRMC studies are used to evaluate diagnostic imaging systems or AI tools.

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

Not applicable. This is for a physical medical device. "Standalone algorithm performance" is not relevant here.

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

For the mechanical performance data, the "ground truth" is defined by the ASTM F1717 standards and the "Guidance for Spinal System 510(k)s", which specify the test methodologies and acceptable limits for mechanical properties (e.g., strength, stiffness, fatigue life). The performance of the predicate device also serves as a benchmark for "substantial equivalence."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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510(k) Summary: UNIFY™ Dynamic Anterior Cervical Plate System

Company: Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800

Contact: Meriam Youssef Project Manager, Requlatory Affairs

Date Prepared: April 5, 2012

Device Name: UNIFY™ Dynamic Anterior Cervical Plate System

Classification: Per 21 CFR as follows: §888.3060: Spinal Intervertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: II, Panel Code: 87

ASSURE® Anterior Cervical Plate (K040721) Predicate(s): PROVIDENCE® Anterior Cervical Plate (K070775) XTEND® Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K063100) Synthes Vectra™ Anterior Cervical Plate (K051665)

Purpose:

The purpose of this submission is to request clearance for the UNIFY™ Dynamic Anterior Cervical Plate System, a modification of the cleared ASSURE® Anterior Cervical Plate System.

Device Description:

UNIFY™ Dynamic Anterior Cervical Plate System implants are manufactured from titanium alloy, as specified in ASTM standards F136 and F1295.

Indications for Use:

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KI21049

trauma (including fractures), tumors, deformity (kyphosis or scollosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

Technological Characteristics:

The technological characteristics of the UNIFY™ Dynamic Anterior Cervical Plate System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

Performance Data:

Mechanical testing (static and dynamic compression, static torsion, and static tension) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device.

Basis of Substantial Equivalence:

The UNIFY™ Dynamic Anterior Cervical Plate System has been found to be substantially equivalent to the predicates with respect to technical characteristics. performance, design, materials and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Globus Medical, Inc. % Ms. Meriam Youssef Project Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K121049

Trade/Device Name: UNIF Y Dynamic Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 31, 2012 Received: June 01, 2012

Dear Ms. Youssef:

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 vour 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

JUN 2 7 2012

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Page 2 - Ms. Meriam Youssef

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. 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

for N. Mulle

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

Enclosure

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K12104.9

Indications for Use Statement

510(k) Number:

KI 21049

Device Name:

UNIFY™ Dynamic Anterior Cervical Plate System

INDICATIONS:

Prescription Use ਮ (Per 21 CFR §801.109) Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

KIZIOH 4

(Division Sign-Ori) (Division Sign-On)
Division of Surgical, Orthopedic, Wishon of State Devices

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.