The Gexfix devices, in common with similar devices from other manufacturers, are intended only to assist during the healing process, and so are not intended to replace normal bone structures.

The Gexfix External Fixation devices are intended use a physical mechanism of action to hold bones in positions that aid stability during healing, thus facilitating the normal healing process. Some elements of the system are implantable during the healing process, with the main structural support being provided by external mechanical elements.

the predicate device, as cleared under K052605.

The Gexfix range includes external fixation devices for use in a variety of orthopedic applications. They are supplied non-sterile for single use, although some accessory items can be reused. Users are instructed to sterilize the components before use, using a sterilization cycle validated to achieve a sterilization Assurance Level (SAL) of at least 10-6.

The Gexfix range of external fixation devices comprises three main elements, these being:

Invasive components
. External components
Ancillary components

This submission covers new components of the Gexfix system that are being added to the range of all three of the above types of component when compared with the predicate device. Some new components have an extended range of available dimensions, while other new components are additions to the range, to fulfil user needs for greater variety in the range of surgical applications, such as the introductions of components to allow external fixation of bones in the fingers, feet and shoulder.

Biocompatibility of patient-contacting materials is assured by using materials that meet applicable standards (e.g. for stainless steel and titanium alloy components) or by using materials which have received previous 510(k) clearance (e.g. PEEK).

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Gexfix External Fixation." This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert-established ground truth, adjudication, MRMC study, standalone performance, training set details), and effect sizes cannot be directly extracted from this document, as it describes a different type of regulatory submission.

The document highlights the device's intended use for:

Bone fracture fixation
Osteotomy
Arthrodesis
Correction of deformity
Revision procedures where other devices have been unsuccessful
Bone reconstruction procedures

It also mentions nonclinical testing conducted based on compliance with ASTM F1541-02(2011), 'Standard Specification and Test Methods for External Skeletal Fixation Devices'. The tests included:

Bending
Traction
Compression
Sliding
Torsion
Pin push-out

The document states: "All tests resulted in the components being tested meeting predetermined acceptance criteria." However, it does not specify what those predetermined acceptance criteria were (e.g., specific thresholds for bending strength, torsion resistance, etc.), nor does it provide the detailed results that would form the "reported device performance" in a table. It also does not involve human readers, AI, or ground truth derived from expert consensus or pathology in the way an AI/ML device would.

The document states that the training set for the device's manufacturing (in a very broad sense, covering design and testing) would be the data and specifications from the predicate device (K052605) and current engineering standards. However, this is not a training set in the context of an AI/ML model for which the other questions are relevant.

In summary, the provided text does not contain the detailed information necessary to answer the prompt as extensively as desired for an AI/ML medical device study. It confirms that the device met "predetermined acceptance criteria" through nonclinical mechanical testing, but the specifics of those criteria and the detailed study setup (like sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc., typically associated with AI/ML or diagnostic device evaluations) are not present in this 510(k) summary, as it is a substantial equivalence submission for a mechanical device.

No information regarding acceptance criteria or study details for an AI/ML device (e.g., diagnostic accuracy, reader performance improvement) can be provided as this document pertains to a mechanical external fixation device.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized 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

December 28, 2016

Gexfix International Corp. % Roger Gray VP, Quality and Regulatory Donawa Lifescience Consulting S.R.L. Piazza Albania, 10 Rome, 00153 Italy

Re: K160972 Trade/Device Name: Gexfix External Fixation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 23, 2016 Received: November 28, 2016

Dear Roger Gray:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Caroline Rhim -S

for

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 Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160972

Device Name

Gexfix External Fixation

Indications for Use (Describe)

Bone fracture fixation
Osteotomy
Arthrodesis
Correction of deformity
Revision procedures where other devices have been unsuccessful
Bone reconstruction procedures

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows a logo for a company called "Gexfix". The logo consists of a blue circle with a white "G" inside. The "G" is stylized with a horizontal line extending from the left side of the "G" to the right side, creating a unique design. Below the circle, the word "Gexfix" is written in black, sans-serif font.

APPENDIX E

510(k) Summary in accordance with 21 CFR 807.92(c)

Type of Submission:	Traditional 510(k)
Date of Submission:	21 November 2016
Device Proprietary Name:	Gexfix External Fixation
FDA Product Code:	KTT
FDA Regulation Number:	21 CFR 888.3030
FDA Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories
FDA Identification:	Single/multiple component metallic bone fixation appliances andaccessories are devices intended to be implanted consisting of one ormore metallic components and their metallic fasteners. The devicescontain a plate, a nail/plate combination, or a blade/plate combinationthat are made of alloys, such as cobalt-chromium-molybdenum, stainlesssteel, and titanium, that are intended to be held in position withfasteners, such as screws and nails, or bolts, nuts, and washers. Thesedevices are used for fixation of fractures of the proximal or distal end oflong bones, such as intracapsular, intertrochanteric, intercervical,supracondylar, or condylar fractures of the femur; for fusion of a joint; orfor surgical procedures that involve cutting a bone. The devices may beimplanted or attached through the skin so that a pulling force (traction)may be applied to the skeletal system.
FDA Panel:	Orthopedic
FDA Classification:	Class II
510(k) Owner/Submitter:	Gexfix International Corporation(previously registered as Gexfix USA Inc.)55 NE Avenue, Suite 501Boca Raton, FL 33432USA
FDA Registration Number:	3005112659
Device Manufacturer:	Gexfix S.A.Avenue de la Praille 50CH-1227 CarougeSwitzerland
	Tel: +41 22 308 16 70Fax: +41 22 308 16 79

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Image /page/4/Picture/1 description: The image shows the logo for Gexfix. The logo consists of a blue circle with a white "G" shape inside. Below the circle, the word "Gexfix" is written in black, bold letters. The logo appears to be for a company or organization named Gexfix.

FDA Registration Number:	3005157180
510(k) Correspondent:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
	Tel: +39 06 578 2665Fax: +39 06 574 3786Email: rgray@donawa.com
Intended Use / Indications for Use:	1) Bone fracture fixation2) Osteotomy3) Arthrodesis4) Correction of deformity5) Revision procedures where other devices have been unsuccessful6) Bone reconstruction procedures

Device Description:

The use of External Fixation devices provides surgeons with a means of bone fixation for the management of fractures and reconstructive surgery.

The Gexfix devices, in common with similar devices from other manufacturers, are intended only to assist during the healing process, and so are not intended to replace normal bone structures.

the predicate device, as cleared under K052605.

The Gexfix range of external fixation devices comprises three main elements, these being:

Invasive components
. External components
Ancillary components

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Image /page/5/Picture/1 description: The image features the logo of Gexfix. The logo consists of a blue circle with a stylized letter 'G' inside. The 'G' is also blue and has a break in the upper left quadrant of the circle. Below the circle is the word 'Gexfix' in a bold, black font.

additions to the range, to fulfil user needs for greater variety in the range of surgical applications, such as the introductions of components to allow external fixation of bones in the fingers, feet and shoulder.

Nonclinical testing:

Testing of the new components has been conducted on the basis of compliance with ASTM F1541-02(2011), 'Standard Specification and Test Methods for External Skeletal Fixation Devices'.

Testing has included, as appropriate to the constructs concerned, mechanical testing in:

. Bending
Traction
Compression
Sliding
Torsion
. Pin push-out

Tests were carried out on the following components/constructs:

Digifix and mini-pins
. K-wires
Lateral entry connections
Shoulder osteosynthesis device (DOS) ●
External fixation
Minibone
Gex-foot
Caslau bar
Pins
Implantable elements

All tests resulted in the components being tested meeting predetermined acceptance criteria.

Labeling

MR Environment labeling has been introduced in accordance with ASTM F2503–13, 'Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment'.

Unique Device Identification labeling has also been introduced.

Substantial equivalence:

The predicate device for comparison with Gexfix External Fixation is the original version of the device, as cleared by FDA in K052605:

Predicate Device:.......................Gexfix External Fixation Sponsor:...................................................................................................................................................................... 510(k) Number: ......................K052605 Clearance Date: .....................................10 November 2005 FDA Product Code: .......................KTT Classification Name: .........Single/multiple component metallic bone fixation appliances and accessories

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Image /page/6/Picture/1 description: The image contains the logo for Gexfix. The logo features a stylized letter 'G' in a blue circle. Below the circle, the word 'Gexfix' is written in a bold, sans-serif font.

Regulation No:...............................21 CFR 888.3030

The subject device and the predicate devices have many identical or similar properties or features and share identical intended uses and indications for use.

The fundamental technology of the original and modified device is unchanged. Both the original and extended range of components in the Gexfix External Fixation comprise various elements that can be assembled by the orthopedic surgeon to help treat a wide variety of bone fractures and associated conditions. The range includes elements which are invasive, including those for temporary implantation; elements which are attached to the invasive components but which themselves are external to the patient; and elements that are required in order to either assemble the invasive and external components together, or to aid in the temporary implantation process.

The technical specifications are identical between the two devices except for the following:

Invasive components:

The introduction of titanium (Ti6Al4V) versions of components alongside the original stainless steel versions
. An extension of the range of available dimensions of certain components

External components:

The introduction of Lateral Entry Connection components ●
. The introduction of the Shoulder Osteosynthesis Device (DOS)
The introduction of Digifix
The introduction of Adynex
The introduction of Gex-finger
The introduction of Caslau Bar
The introduction of Gex-foot
The introduction of Minibone
The introduction of titanium (Ti6Al4V) versions of certain components
An extension of the range of available dimensions of certain components

Ancillary components:

The introduction of two new components: Allen Key, Universal Key, K-wire Finger Implantation ● Guide
An extension of the range of Trays available ●

The original device and the subject device interact with the patient in exactly the same ways.

The original device and the subject device interact with other devices in exactly the same way.

These differences have no significant effect on the safety or effectiveness of the subject device.

Summary:

All of the new range additions detailed in this submission have been reviewed and tested, and none have been identified as having any significant effect on the safety and effectiveness of the device when compared with the predicate.

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Image /page/7/Picture/1 description: The image shows the logo for Gexfix. The logo consists of a blue circle with a white horizontal line through the middle, and a white "G" inside the circle. The text "Gexfix" is written in black below the circle.

Substantial Equivalence Conclusion:

Based on the information contained within this submission, it is concluded that the components that make up the extension to the range of components in the Gexfix External Fixation device are substantially equivalent to the identified predicate device components cleared under K052605, which are already in interstate commerce within the USA.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.