The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

Device Description

The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixation as an aid to fusion. The Gibralt Spine System Facet Screw components are available in a variety of sizes and are manufactured from titanium alloy per ASTM F136.

The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.

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

AI/ML Overview

The provided text describes a medical device, the Exactech® Gibralt™ Spine System Facet Screw, for which a 510(k) premarket notification was submitted. The approval is based on substantial equivalence to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, the study conducted focused on biomechanical assessment.

Therefore, many of the requested categories related to clinical study design, ground truth, expert adjudication, and multi-reader effectiveness are not applicable to the information provided.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) application in this context is substantial equivalence to existing legally marketed devices. For a mechanical device like a facet screw, this often means demonstrating comparable mechanical performance.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (from "510(k) Summary")
Mechanical Performance	Comparable mechanical properties to predicate devices.	"The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates."
Material Composition	Biocompatible, recognized medical-grade materials.	"manufactured from titanium alloy per ASTM F136."
Sterilization	Capable of being sterilized to ensure patient safety.	"The products must be steam sterilized by the hospital prior to use."
Indications for Use	Consistent with predicate devices.	"posterior surgical treatment at C2-S1 (inclusive) spinal levels for ... DDD, spondylolisthesis, spondylolysis, fracture, or failed previous fusion." (This matches the scope of predicate devices for similar spinal fixation).

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

Sample Size for Test Set: Not explicitly stated as this was a biomechanical study, not a clinical trial or AI evaluation. It would involve a sufficient number of devices for mechanical testing.
Data Provenance: The study was a "biomechanical assessment," implying laboratory testing. The country of origin for the data is not specified, but it would presumably be performed by or for the manufacturer (Exactech®, Inc. in Gainesville, FL, USA). It is a retrospective comparison to previously established performance data of predicate devices.

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

Not Applicable. For a biomechanical study, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical opinion. The "experts" would be engineers and biomechanical scientists.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication is relevant for subjective assessments (e.g., image interpretation). Biomechanical testing results are objective measurements.

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

No. This type of study is for evaluating human performance, often in conjunction with AI for diagnostic tasks. The provided information describes a mechanical device assessment.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

For the biomechanical assessment, the "ground truth" is based on accepted engineering standards and physical laws for material strength, fatigue, and structural integrity, as applied to spinal implants. This includes compliance with standards like ASTM F136 for materials.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of a 510(k) biomechanical assessment for a mechanical device. This concept applies to machine learning or AI algorithm development.

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

Not Applicable. No training set was used.

Summary

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KIL2097

NOV 2 1 2011

Exactech® Gibralt" Spine System Facet Screw Traditional 510(k)

510(k) Summary

Company:	Exactech ®, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	October 5, 2011
Contact Person:	Vladislava ZaitsevaRegulatory Affairs SpecialistPhone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Gibralt™ Spine System Facet Screw
Common Name:	Facet screw spinal device
Classification Name:	Unclassified
Product Code:	MRW

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

TranS1 Facet Screw (K073515) .
Spartan S3 Facet System (K092568) ●
Corridor Fixation System (K083442) .
. US Spine Facet Fixation System (K061041)
DePuy AcroMed Discovery Facet Screw (K012773)
SpineFrontier Chameleon Fixation System (K071420) .

Device Description

The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.

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

Indications for Use

The Gibralt Spine System Facet Screw is indicated for posterior surgical treatment at C2-$1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with

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Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)

A biomechanical assessment comparing Gibralt Facet Screw mechanical . performance to cited predicate devices.
The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates.

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

NOV 2 1 2011

Exactech, Inc. % Ms. Vladislava Zaitseva 2320 N.W. 66th Court Gainesville, Florida 32653

Rc: K112097

Trade/Device Name: Gibralt Spine Systems Facet Screw Regulatory Class: Unclassified Product Code: MR W Dated: October 05, 2011 Received: October 12, 2011

Dear Ms. Zaitseva:

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

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Page 2 - Ms. Vladislava Zaitseva

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.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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erin S. Keith

for 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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Exactech® Gibralt™ Spine System Facet Screw Traditional 510(k)

Indications for Use Statement

510(k) Number:

KII2097

Device Name: Exactech® Gibralt™ Spine System Facet Screw

INDICATIONS FOR USE:

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

and/or

Over-The-Counter Use
(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)

(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K112097 510(k) Number_

Regulation Number and Section

N/A