When used with the Gibralt System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors.

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in TI-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Device Description

The Gibralt Occipital Spine System is a new posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital-cervical-thoracic region of the spine.

The system consists of a variety of sizes of the occipital plates and occipital bone screws, and articulating rod and set screws. All components of the system are manufactured from titanium allov per ASTM F136.

The Gibralt Occipital system should be used in conjunction with the Gibralt Spine System components such as hooks, polyaxial screws and connecting components. The Gibralt Spine System has been cleared by FDA through 510(k) # K 110197 on July 15, 2011.

The Gibralt Occipital Spine System is provided with a complete instrumentation system to assist the surgeon in the implantation of the components according to a traditional open surgical procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Exactech® Gibralt® Occipital Spine System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance through clinical studies with acceptance criteria in the manner requested.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (like sensitivity, specificity, accuracy, etc.) cannot be extracted from this document, as it is not a clinical study report for AI/CADe devices.

Instead, the document details mechanical testing and engineering analyses performed to demonstrate substantial equivalence to predicate devices. This represents the "study" conducted for this type of medical device submission.

Here's a breakdown of the available information, reframed to address the spirit of your request:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Equivalence):

The "acceptance criteria" for a 510(k) submission for this type of device are primarily about demonstrating that its mechanical performance is comparable to legally marketed predicate devices, ensuring it can withstand clinically relevant biomechanical loads. The "reported device performance" refers to the results of the mechanical tests performed.

Acceptance Criteria (Demonstrates Substantial Equivalence via Mechanical Properties)	Reported Device Performance (Summary of Test Results)
Withstand clinically relevant biomechanical loads comparable to predicate devices.	Mechanical testing (Static Compression Bend, Dynamic Compression Bend, Static Yield Torsion, Dynamic Torsion, Axial Pullout, Static Torque per ASTM F2706 and ASTM F543) and biomechanical assessment demonstrated the proposed device is substantially equivalent to cited predicates in mechanical performance and design features.

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

Test Set Sample Size: Not applicable in the context of clinical performance of an AI/CADe device. For mechanical testing, the "sample size" would refer to the number of device components tested. This specific number is not provided in the summary.
Data Provenance: The mechanical testing was conducted by or for Exactech®, Inc. The country of origin for the data is implicitly the manufacturing location or testing facility, likely the USA (where Exactech is based). The data is prospective in the sense that these tests were specifically performed for this 510(k) submission to evaluate the new device.

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

Not applicable. For this type of mechanical device, "ground truth" is established through standardized engineering tests and measurements, not through expert consensus on clinical data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical ground truth establishment, which is not relevant here.

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

No. This is a submission for a spinal implant system, not an AI/CADe device that assists human readers. Therefore, an MRMC study is not relevant and was not performed.

6. Standalone (Algorithm Only) Performance Study:

No. This is a submission for a physical medical device. "Standalone performance" in the context of AI algorithms does not apply.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence for this device is based on standardized biomechanical and material testing specifications (e.g., ASTM F2706, ASTM F543) and comparisons to the established mechanical properties and design features of predicate devices. It's not clinical "ground truth" like pathology or outcomes data.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device's mechanical test data.

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

Not applicable.

Summary

{0}------------------------------------------------

510(k) Summary

FEB 1 2 2013

Company:	Exactech®, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	January 14, 2013
Contact Person:	Vladislava ZaitsevaSr. Regulatory Affairs Specialist
	Phone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Gibralt® Occipital Spine System
Common Name:	Occipital Plate System
Classification Name:	Appliance, fixation, spinal interlaminal
Product Code:	KWP

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

DePuy Mountaineer OCT Spinal System (K110353, K042508, and K041203) .
t Medtronic Vertex Select Reconstruction System (K110522, K091365, K090714, and K082728)
Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) .

Device Description

The Gibralt Occipital Spine System is provided with a complete instrumentation system to assist the surgeon in the implantation of the components according to a traditional open surgical procedure.

{1}------------------------------------------------

Indications for Use

When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with deveneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors.

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use/Indications for Use . The proposed Gibralt Occipital Spine System and predicates have similar indications for use statements.
. Materials

The proposed Gibralt Occipital Spine System components and predicate devices are composed of titanium allov, a biocompatible material conforming to a recognized industry standard for permanent implants.

. Design Features

The proposed Gibralt Occipital Spine System components and predicate devices have similar design features.

• Dimensions
The proposed Gibralt Occipital Spine System components and predicate devices are dimensionally comparable.

. Packaging and Sterilization

The proposed Gibralt Occipital Spine System components and predicate devices are provided non-sterile for single use only, and will be steam sterilized by the hospital prior to use in the operating room using the same sterilization method.

. Device Shelf Life
Neither the Gibralt Occipital Spine System components nor cited predicate devices have shelf life expiration dating.
. Performance specifications The Gibralt Occipital Spine System and cited predicates all withstand clinically relevant biomechanical loads.

{2}------------------------------------------------

Substantial Equivalence Conclusion

The following mechanical testing and engineering analyses were conducted to demonstrate substantial equivalence of the proposed Gibralt Occipital Spine System to cited predicates:

Static Compression Bend, Dynamic Compression Bend, Static Yield Torsion, . Dynamic Torsion, Axial Pullout and Static Torque testing per ASTM F2706 and ASTM F543.
A biomechanical assessment comparing Gibralt Occipital Spine System . mechanical performance and design features to cited predicate devices.

The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing protection and care.

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

Letter dated: February 12, 2013

Exactech®, Incorporated % Travis Arola, MS, RAC, CTBS Director, Regulatory, Spine & Biologics 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K121877

Trade/Device Name: Exactech® Gibralt® Occipital Spine System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 14, 2013 Received: January 16, 2013

Dear Mr. Arola:

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. Iisting 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 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.

{4}------------------------------------------------

Page 2 - Travis Arola, MS, RAC, CTBS

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/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.

Mark Melkerson

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

Enclosure

{5}------------------------------------------------

Indications for Use Statement

K121877 510(k) Number:

Device Name: Exactech® Gibralt® Occipital Spine System

INDICATIONS FOR USE:

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in TI-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Over-The-Counter Use Prescription Use X and/or (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald PaJean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121877

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.