a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery

Device Description

The AZURE Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

AI/ML Overview

The provided text describes the AZURE Anterior Cervical Plate System, a medical device, and its premarket notification. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance
Static Torsion Test	ASTM F1717-12	"Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device."
Static Axial Compression Bending Test	ASTM F1717-12	"Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device."
Dynamic Axial Compression Bending Test	ASTM F1717-12	"Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device."

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

The document does not specify the exact sample sizes (number of devices tested) for the mechanical tests. The data provenance is non-clinical, meaning it's from laboratory testing of the device itself, not from human or animal subjects. The testing was conducted in a laboratory setting to ASTM F1717-12 standards.

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

This question is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by expert medical consensus. The performance is objectively measured against the criteria defined by ASTM F1717-12.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical mechanical testing. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth for clinical data. Here, performance is determined by objective measurements meeting predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic or assistive AI system on human reader performance for interpretation of medical images or data. The AZURE Anterior Cervical Plate System is a physical implant, not a diagnostic or AI-driven system.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. Again, this device is a physical implant, not an algorithm. The performance evaluation is based on its mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance study (mechanical testing) is the established engineering specifications and performance thresholds defined within the ASTM F1717-12 standard. The device's ability to withstand static torsion, static axial compression bending, and dynamic axial compression bending according to this standard is the objective measure of its performance.

8. The Sample Size for the Training Set

This is not applicable. Training sets are used in the development of AI algorithms. This document is for a physical medical device (an anterior cervical plate system), not an AI algorithm.

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

This is not applicable, as there is no training set for a physical implant.

Summary

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K130825 Page 1 of 3

Premarket Notification, Special 510(k) AZURE Anterior Cervical Plate System

510(k) SUMMARY

MAY 0 7 2013

AZURE Anterior Cervical Plate System

Submitter Information

Name:	Orthofix Inc.
Address:	3451 Plano ParkwayLewisville, TX 75056
Telephone Number:	214-937-2000
Fax Number:	214-937-3322
Email:	alisonbaduel@orthofix.com
Registration Number:	3008524126
Contac Person:	Ally BaduelRegulatory Affairs Specialist
Date Prepared:	March 22, 2012
Name of Device
Trade Name/Proprietary Name:	AZURE Anterior Cervical Plate System
Common Name:	anterior cervical plate system
Product Code:	KWQ - Appliance, Fixation, Spinal Intervertebral Body
Regulatory Classification:	Class II - 888.3060 - Spinal intervertebral body fixation orthosis
Review Panel:	Orthopedic Device Panel
Predicate Devices:	Orthofix Anterior Cervical Plate System (K121658) &Hallmark Anterior Cervical Plate System (K050892 and K100614)

Reason for 510(k) Submission: Device modification to cervical plates

Device Description

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Premarket Notification, Special 510(k) AZURE Anterior Cervical Plate System

surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

Intended Use / Indications for Use

The AZURE Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc a) confirmed by patient history and radiographic studies);
Spondylolisthesis: b)
Trauma (i.e., fracture or dislocation); c)
. Spinal stenosis; d)
Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
() Tumor;
Pseudoarthrosis; ള)
Revision of previous surgery h)

Summary of Technological Characteristics of the Device Compared to the Selected Predicate Devices

Characteristic	Subject Device	Predicate Devices
Device Name	AZUREAnteriorCervical PlateSystem	Orthofix AnteriorCervical Plate System(K121568)	Hallmark AnteriorCervical Plate System(K050892)	Hallmark AnteriorCervical Plate System(K100614)
Method ofFixation	ACP systemintended foranterior fixationto the cervicalspine from C2to C7.	ACP system intendedfor anterior fixation tothe cervical spine fromC2 to C7.	ACP system intended foranterior fixation to thecervical spine from C2 toC7.	ACP system intendedfor anterior fixation tothe cervical spine fromC2 to C7.
Implantation	Anteriorapproach	Anterior approach	Anterior approach	Anterior approach
Design	Plates (1-levelthrough 5-level)	Plates (1-level through5-level)	Plates(1-level through 4-level)	Plates(5-level plate only)
Material	Ti6Al4V ELIper ASTMF136 andNitinol perASTM F2063.	Ti6Al4V ELI perASTM F136 and Nitinolper ASTM F2063.	Ti6Al4V ELI per ASTMF136.	Ti6Al4V ELI perASTM F136.

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PERFORMANCE DATA-Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Characteristic	Standard / Test/ FDA Guidance
Static Torsion Test	ASTM F1717-12
Static Axial Compression Bending Test	ASTM F1717-12
Dynamic Axial Compression Bending Test	ASTM F1717-12

Performance Data Summary

Mechanical testing for the subject AZURE Anterior Cervical Plate System was conducted in accordance to ASTM F1717-12- Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model. Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device the Hallmark Anterior Cervical Plate System (K050892 and K 100614) that have the same intended use, similar indications, technological characteristics, and principles of operation.

Basis of Substantial Equivalence

The subject AZURE Anterior Cervical Plate System is substantially equivalent in design, configuration, function, and indications for use to the Orthofix Anterior Cervical Plate System (K121658) and is substantially equivalent in design, configuration, function, performance and indications for use to the Hallmark Anterior Cervical Plate System (K050892 & K100614).

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Image /page/3/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 forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

May 7, 2013

Orthofix, Incorporated % Ms. Ally Baduel Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K130825

Trade/Device Name: AZURE 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: April 09, 2013 Received: April 10, 2013

Dear Ms. Baduel:

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. Ally Baduel

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin - Weith

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

. K130825 510(k) Number (if known):

Device Name: AZURE Anterior Cervical Plate System

Indications for Use:

The AZURE Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
Tumor; f)
g) Pseudoarthrosis;
Revision of previous surgery h)

Prescription Use: X (Part 21 CFR 801 Subpart D)

And/Or

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.