The Orthofix Galaxy Fixation System and is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required.

The indications for use include:

Open or closed fractures in long bones;
Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
Infected and aseptic non-unions;
joint pathologies/injuries of upper and lower limbs such as:
- proximal humeral fractures; .
- intra-articular knee, ankle and wrist fractures; .
- Delayed treatment of dislocated and stiff elbows; .
- Chronic, persistent elbow joint instability; .
- Acute elbow joint instability after complex ligament injuries; .
- Unstable elbow fractures; .
- Additional elbow stabilization of post-operative unstable internal fixation. .

Device Description

The Orthofix Galaxy Fixation System includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use.

The Galaxy Fixation System can be combined to construct different frame configurations that have been shown to be MR conditional in 1.5T and 3T MR environment. The system consists of various modules which are designed to be applied in different anatomical sites of the upper and lower limb as well as the pelvis and allow the surgeon to:

Position screws where the condition of the bone and soft tissues permits
Reduce the fracture in order to restore alignment
Stabilize the fracture safely

AI/ML Overview

The Orthofix Galaxy Fixation System is a medical device and, as such, its acceptance criteria and the study proving it meets these criteria are based on non-clinical laboratory testing rather than human clinical studies with performance metrics like sensitivity, specificity, or reader improvement.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily centered around demonstrating substantial equivalence to predicate devices through mechanical performance and safety in a Magnetic Resonance (MR) environment.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance	The Orthofix Galaxy Fixation System must demonstrate mechanical strength and performance that is equivalent to or better than the predicate devices. This includes: - Static testing on Connector - Static testing on Joint - Static testing on Construct - Static testing on Ring Segment - Multi-cycle testing on Construct (Fatigue tests on Configurations) - Force and Torque Testing	Testing in accordance with ASTM 1541-02 shows the mechanical strength of the Galaxy Fixation system to be equivalent or better than the predicate devices. Specific numerical results are not provided in this summary but the statement confirms the device met this criterion.
MR Environment Safety	The Orthofix Galaxy Fixation System must demonstrate safety and compatibility in a Magnetic Resonance environment, specifically: - Radio Frequency Heating Testing - Artifact Testing The system must be "MR Conditional" in 1.5T and 3T MR environments.	The Galaxy Fixation System can be combined to construct different frame configurations that have been shown to be MR conditional in 1.5T and 3T MR environment. Testing was performed to assess Radio Frequency Heating and Artifacts, with the implication that the results confirmed MR conditional compatibility under predetermined conditions, similar to one of the predicate devices (Hoffmann 3 Modular External Fixation System, K111786).

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

For a medical device like the Orthofix Galaxy Fixation System, the "test set" refers to the specific configurations and components of the device that underwent non-clinical laboratory testing.

Sample Size: The document does not specify an exact numerical sample size for the mechanical and MR environment tests (e.g., "N units tested for static strength"). Instead, it states that "the Orthofix Galaxy Fixation System" underwent testing, implying a representative selection of various frames, bars, clamps, and accessories.
Data Provenance: The testing was "non clinical laboratory testing" performed by the manufacturer, Orthofix Srl, likely at their facilities or a contracted testing lab. The location is Italy (Bussolengo (VR)), as indicated by the submitter's address. This is inherently prospective for the device being submitted, as the tests were conducted specifically to support this 510(k) submission.

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 the context of this 510(k) submission. For mechanical and MR safety testing of a physical medical device, "ground truth" is established by adherence to recognized preclinical testing standards (e.g., ASTM 1541-02) and objective measurements using calibrated equipment, not by human expert consensus or interpretation of images. The performance is objectively measured against engineering specifications and predicate device performance.

4. Adjudication Method for the Test Set

This question is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment (e.g., radiology reads) to resolve discrepancies among experts.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI tools where human readers interpret medical images. The Orthofix Galaxy Fixation System is an external fixation device, and its evaluation focuses on mechanical and safety performance.

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

This question is not applicable. The Orthofix Galaxy Fixation System is a physical medical device, not an algorithm or AI system. Its "performance" is inherently standalone in the sense that the device itself is tested for its physical properties and interactions with an MR environment, without human "in-the-loop" performance as a diagnostic aid.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Orthofix Galaxy Fixation System is established by:

Engineering Specifications and Standardized Test Methods: Adherence to established industry standards like ASTM 1541-02 for mechanical testing.
Objective Measurements: Direct measurement of forces, torques, fatigue cycles, RF heating, and artifact size using specialized testing equipment.
Comparison to Predicate Devices: The measured performance of the device is compared directly against the known performance of legally marketed predicate devices, with the ground truth being "equivalent or better" performance.

8. The Sample Size for the Training Set

This question is not applicable. The Orthofix Galaxy Fixation System is a physical medical device, not a machine learning model that requires a "training set."

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

This question is not applicable for the same reason as point 8.

Summary

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SEP 4 2012

Image /page/0/Picture/1 description: The image shows the Orthofix logo, with the word "ORTHOFIX" in bold, sans-serif font. Below the logo, the text "510(k) Summary" is displayed in a smaller, bold font. The phrase "[as required by 21 CFR 807.92(c)]" is printed below the summary title in a regular, non-bold font.

Orthofix Galaxy Fixation System

510(k) K113770

1.	Submitted by:	Orthofix SrlVia delle Nazioni 937012 Bussolengo (VR)Italy
	Registration number	9680825
	Contact Person	Elvira TaccarelliRegulatory Affairs
	Telephone:	+39 (045) 671 9000
	Facsimile:	+39 (045) 671 9380
	Date Prepared	July 30, 2012

2. Device Name:

Trade/Proprietary Name	Orthofix Galaxy Fixation System
Common Name	External Fixation Device and Accessories
Device Classification	87KTT (21 CFR 888.3030)

3. Predicate Device:

The Orthofix Galaxy Fixation System is substantially equivalent in intended use, materials and technological characteristics to the following external fixation systems:

· Synthes External Fixation Systems, cleared under K082650 and K090658
· Orthofix Dynamic Axial Fixation System, cleared under K955848
· Additional Accessories for the Orthofix System, cleared under K944092
· Smith & Nephew Jet-X® Bar System Clamps, Bars and Posts MR Conditional, cleared under K072212
· Hoffmann 3 Modular External Fixation System, cleared under K111786

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K113770

4. Intended Use:

The indications for use include:

Open or closed fractures in long bones;
Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
Infected and aseptic non-unions;
joint pathologies/injuries of upper and lower limbs such as:
- proximal humeral fractures; .
- intra-articular knee, ankle and wrist fractures; .
- Delayed treatment of dislocated and stiff elbows; .
- Chronic, persistent elbow joint instability; .
- Acute elbow joint instability after complex ligament injuries; .
- Unstable elbow fractures; .
- Additional elbow stabilization of post-operative unstable internal fixation. .

5. Description:

This Traditional 510(k) is being supplied to the U.S. FDA to provide authorization to market the device "Orthofix Galaxy Fixation System" for interstate commerce.

Position screws where the condition of the bone and soft tissues permits
Reduce the fracture in order to restore alignment
Stabilize the fracture safely

Substantial equivalence: 6.

Documentation is provided which demonstrates the Orthofix Galaxy Fixation System to be substantially equivalent to other legally marketed devices. Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the legally marketed predicate devices, the Synthes External Fixation Systems, cleared under 510(k)

f. 2.63

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K11370

K082650 and K090658, the Orthofix Dynamic Axial Fixation System (marketed as the Orthofix Procallus, Minirail System, Limb Reconstruction System, XCaliber Fixator, etc.) cleared under 510(k) K955848, Orthofix Dynamic Axial Fixation System additional accessories (marketed as the Fragment Fixation System, etc.) cleared under 510(k) K944092, the Smith & Nephew Jet-X® Bar System Clamps, Bars and Posts - MR Conditional, cleared under K072212 and testing in a Magnetic Resonance Environment safely used in Magnetic Resonance Imaging, under predetermined conditions cleared in K111786 of Hoffmann 3 Modular External Fixation System.

The components included in the Orthofix Galaxy Fixation system and the predicate devices are all external fracture fixation systems as defined in 21 CFR 888.3030, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices. Testing in accordance with ASTM 1541-02 shows the mechanical strength of the Galaxy Fixation system to be equivalent or better than the predicate devices.

6. Non Clinical testing:

Non clinical laboratory testing was performed on the Orthofix Galaxy Fixation System to determine substantial equivalence. The following testing was performed:

Mechanical performance: Static on Connector Static on Joint Static on Construct Static on Ring Segment Multi-cycle on Construct Fatique tests on Configurations Magnetic Resonance Environment Testing Radio Frequency Heating Testing Force and Torque Testing Artifact Testing

7. Conclusion:

Based upon the similarities in design, materials and intended uses, the Orthofix Galaxy Fixation System is substantially equivalent to the predicate devices.

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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 features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

Orthofix SRL % Ms. Candace Cederman Consultant 22423 Skyview Drive West Linn, Oregon 97068

4 2012 SEP

Re: K113770

Trade/Device Name: OrthoFix Galaxy Fixation System 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: August 3, 2012

Dear Ms. Cederman:

Received: August 6, 2012

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 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.

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Page 2 - Ms. Candace Cederman

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,

Evin L. Keith

ForMark 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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Indications for Use

K113770 510(k) Number (if known):

Orthofix Galaxy Fixation System Device Name:

Indications for Use:

The Orthofix Galaxy Fixation System and is intended to be used for bone The Ortholix Octably Pillers and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required.

The indications for use include:

Open or closed fractures in long bones;
Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
Infected and aseptic non-unions;
joint pathologies/injuries of upper and lower limbs such as:
- proximal humeral fractures; .
- intra-articular knee, ankle and wrist fractures; .
- Delayed treatment of dislocated and stiff elbows; ●
- Chronic, persistent elbow joint instability; .
- Acute elbow joint instability after complex ligament injuries; .
- Unstable elbow fractures; .
- Additional elbow stabilization of post-operative unstable internal fixation. .

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asit

(Division Sign-Off) Divilion of Surgical, Orthopedic, and Restorative Devices

KI 3770 510(k) Number _

Page 1 of 1

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.