The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.

When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt® Occipital Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt® Spine System package insert for a list of the Gibralt® Spine System indications of use.

The Occipital Bone Screws are limited to occipital fixation only.

Device Description

The line extension and device modifications for the Gibralt® Spine System are intended to provide immobilization and stabilization of spinal segments in the upper thoracic, cervical, and occipital spine. The system components are manufactured from titanium and cobalt chromium. The modifications included in the scope of this submission are: expanded indications for use for both systems, incorporation of design changes, and addition of new components.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Gibralt® Spine System and Gibralt® Occipital Spine System." It is primarily a regulatory approval document and does not contain the detailed study information typically found in a clinical trial report or a comprehensive technical performance study.

Therefore, the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance of an AI/algorithm-based device cannot be fully provided from this document alone. This document describes a medical device (spinal fixation system) which is a physical implant, not an AI or algorithm-based diagnostic/prognostic device.

However, based on the provided text, I can extract information related to the device's performance data which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission, and the "acceptance criteria" can be inferred from the nature of the tests and the conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing standards and regulatory conclusion)	Reported Device Performance (from "PERFORMANCE DATA" section)
Device strength sufficient for intended use, substantially equivalent to predicate devices.	Non-clinical testing showed:
Consistency with ASTM F1717-14 standards for static and dynamic axial compression and compression bending.	- Static axial compression per ASTM F1717-14
	- Static axial compression bending per ASTM F1717-14
	- Dynamic axial compression per ASTM F1717-14
	- Dynamic axial compression bending per ASTM F1717-14
	Conclusion: "The results of this non-clinical testing show that the strength of the Gibralt® Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document mentions "the Gibralt® Spine System" and "the proposed line extensions and modified Gibralt® Spine System" were tested, implying multiple units or configurations were tested, but an exact number of samples (e.g., number of constructs tested) is not provided.
Data provenance: Not explicitly stated, but the testing would have been conducted by or for Exactech, Inc. or Empirical Testing Corp. in a laboratory setting. Since it's device testing, it is prospective in the sense that the tests were specifically performed for this submission according to established ASTM standards. It is not clinical data from patients/countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document pertains to mechanical testing of a spinal implant, not the assessment of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical performance of the device under mechanical load, measured by objective instruments according to specified ASTM standards.

4. Adjudication method for the test set

Not applicable. See point 3. Mechanical tests follow predefined protocols and objective measurements.

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 a physical spinal implant system, not a diagnostic or prognostic AI/algorithm requiring human reader evaluation.

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

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

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

For this type of device, the "ground truth" for the mechanical performance testing is the objective measurement of physical properties and strength when subjected to various loads and cycles, as defined by the ASTM F1717-14 standard. There is no expert consensus, pathology, or outcomes data involved in generating the mechanical performance data in this context.

8. The sample size for the training set

Not applicable. This document describes the mechanical testing of a physical medical device. There is no "training set" in the context of an AI/algorithm. The device design might be informed by previous designs and engineering principles, but this is not analogous to an AI training set.

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

Not applicable. See 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 seal with the words "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.

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

June 28, 2016

Exactech, Incorporated % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K160697

Trade/Device Name: Gibralt® Spine System and Gibralt® Occipital Spine System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 31, 2016 Received: June 1, 2016

Dear Mr. Kenneth C. Maxwell II:

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 Parts 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement on last page.
510(k) Number (if known)	K160697
Device Name	Gibralt® Spine System
Indications for Use (Describe)	The Gibralt® Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The GibraltⓇ Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
	In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt® Spine System may also be connected to the Exactech® Proliant® System, Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.
Type of Use (Select one or both, as applicable)	[X] Prescription Use (Part 21 CFR 801 Subpart D)[ ] Over-The-Counter Use (21 CFR 801 Subpart C)	[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
[X] Prescription Use (Part 21 CFR 801 Subpart D)	[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page.
-------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K160697
Device Name	Gibralt® Occipital Spine System
Indications for Use (Describe)

When used with the Gibralt® Spine System, the Gibralt® Occipital Spine System is intended
to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the
following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-
C7), and the thoracic spine from T1 - T3: traumatic spinal fractures and/or traumatic
dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors
involving the cervical/thoracic spine; and degenerative disease, including intractable
radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by
radiographic studies, and degenerative disease of the facets with instability. The GibraltⓇ
Occipital Spine System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advanced stage tumors involving
the cervical spine in whom life expectancy is of insufficient duration to permit achievement of
fusion.

In order to achieve additional levels of fixation, the Gibralt® Occipital Spine System may be
connected to the Gibralt® Spine System, using rod-to-rod connectors. Refer to the Gibralt®
Spine System package insert for a list of the Gibralt® Spine System indications of use.

The Occipital Bone Screws are limited to occipital fixation only.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)Page 1 of 2	PSC Publishing Services (301) 443-6740 EF
-------------------------------------	-------------------------------------------

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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5.510(K) SUMMARY

Submitter's Name:	Exactech, Inc.
Submitter's Address:	2320 NW 66th CourtGainesville, FL 32658
Submitter's Telephone:	352.377.1140
Contact Person:	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874
Date Summary was Prepared:	23 June 2016
Trade or Proprietary Name:	Gibralt® Spine SystemGibralt® Occipital Spine System
Common or Usual Name:	Orthosis, Cervical Spinal Pedicle FixationAppliance, Fixation, Spinal Interlaminal
Classification:	Unclassified, Class II per 21 CFR §888.3050
Product Code:	NKG, KWP
Classification Panel:	Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

Gibralt® Spine System:

In order to achieve additional levels of fixation, the Gibralt® Spine System may be connected to the Gibralt® Occipital Spine System with rod-to-rod connectors. The Gibralt®

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Spine System may also be connected to the Exactech® Proliant® System. Exactech® Silverbolt® and Mainframe® Spinal Screw Systems, or Exactech® Hydralok® Exactech, using rod-to-rod connectors and transitional rods. Refer to the specific system package inserts for a list of their indications for use.

Gibralt® Occipital Spine System:

The Occipital Bone Screws are limited to occipital fixation only.

The indications for use for the Gibralt® Spine System and the Gibralt® Occipital Spine System are similar to that of the predicate devices in Table 5-1.

TECHNOLOGICAL CHARACTERISTICS

Gibralt® Spine System components are made from materials that conform to titanium per ASTM F136 and cobalt chromium per ASTM F1537. The Gibralt® Occipital Spine System components are made from materials that conform to titanium per ASTM F136. The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates:

Indications for Use
Materials of Manufacture ●

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510k Number	Trade or Proprietary orModel Name	Manufacturer	Type
K142838	Synapse Occipital-Cervical-Thoracic System	Synthes USA	PrimaryPredicate
K083071	VERTEXTM ReconstructionSystem	Medtronic	Reference
K050979	S4 Spinal System	Aesculap®, Inc.	Reference

Table 5-1 Predicate Devices

PERFORMANCE DATA

The proposed line extensions and modified Gibralt® Spine System have been tested in the following test modes:

Static axial compression per ASTM F1717-14
Static axial compression bending per ASTM F1717-14 ●
Dynamic axial compression per ASTM F1717-14 ●
o Dynamic axial compression bending per ASTM F1717-14

The results of this non-clinical testing show that the strength of the Gibralt® Spine System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Gibralt® Spine System and Gibralt® Occipital Spine System are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.