The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

Device Description

The AREX USA X-FIX is a single use, lightweight, low profile external fixation system designed to treat fractures dislocations of the digits of the hand. The device is designed to help restore proper digit alignment and range of motion while permitting mobilization and normal anatomical movement.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the AREX USA X-FIX, an external PIP joint distraction device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria as might be seen for novel devices. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics against such criteria. The basis for clearance is substantial equivalence to a predicate device, the AREX USA Ligamentotaxor (K094043).

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (AREX USA Ligamentotaxor K094043)	Claimed Substantially Equivalent: The document explicitly states: "The design, materials, and indications for use of the Arex USA X-FIX are equivalent to the Arex USA Ligamentotaxor (K094043) previously approved for market in the United States. No new technology has been employed in the design. The Arex USA X-FIX presents no new issues regarding safety and effectiveness."
Biocompatibility	"The materials employed have an established history of biocompatibility and attached medical literature demonstrates that they are non-irritant and non-toxic."
Safety and Efficacy (due to changes from predicate)	"Performance testing demonstrates that the changes do not affect safety or efficacy." (Note: specific changes or tests are not detailed.)
Risk Assessment Compliance	"Risk Assessment was conducted in compliance with ISO 14971."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission relies on demonstrating substantial equivalence, not a clinical study with a "test set" in the traditional sense of evaluating device performance on patients. The "performance testing" mentioned likely refers to bench testing rather than clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there is no specific "test set" requiring expert adjudication.

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 mechanical external fixation system, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies or AI-related effectiveness are irrelevant to this submission.

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

Not applicable. This device is a mechanical external fixation system, not an algorithm.

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

Not applicable. The submission focuses on substantial equivalence based on material properties, design, and intended use compared to a predicate device. "Ground truth" in a clinical study context is not relevant here.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI model, so there is no training set mentioned or implied.

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

Not applicable. There is no training set.

Summary

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K122415

Page 1 of 2

MAR 1 5 2013

PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: March 21, 2009

External PIP Joint Distraction Device

Applicant:

Arex USA LLC 1709 Hill St. Edgewater, FL 32132

Contact Individual:

Charles Hokanson, Dir. Of Regulatory Affairs 610-715-3263

Trade Name:

X-FIX

Common Name:

Regulation Number: 888.3040

Product Code:

Classification Name: Pin, Fixation, Smooth

Classification:

Class II

HTY

Predicate Device Name:

AREX USA Ligamentotaxor (K094043)

Device Description:

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K122415

The External Fixation System is as follows:

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ReferenceDescriptionA
.TT TITET17 1788 17A=L'AFFAcres of Actively10-40-40-40.014100 AM. (10000) . 1004.00-6.0

Intended Use: The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures of the PIP joint,

Technology Characteristics: The fundamental scientific technology of the X-FIX is substantially equivalent to the predicate device.

Summary of Design Control Activities:

The materials employed have an established history of biocompatibility and attached medical literature demonstrates that they are non-irritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.

Conclusion:

The design, materials, and indications for use of the Arex USA X-FIX are equivalent to the Arex USA Ligamentotaxor (K094043) previously approved for market in the United States. No new technology has been employed in the design. The Arex USA X-FIX presents no new issues regarding safety and effectiveness

Chale-tola

Charles Hokanson Date Director of Regulatory Affairs

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three parallel lines curving upwards and to the right, resembling a stylized human figure.

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

March 15, 2013

Arex USA LLC % Mr. Charles Hokanson Director of Regulatory Affairs 1709 Hill Street Edgewater, Florida 32132

Re: K122415

Trade/Device Name: AREX USA X-FIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: February 8, 2013 Received: February 25, 2013

Dear Mr. Hokanson:

We have reviewed vour 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 - Mr. Charles Hokanson

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/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/ReportalProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and black, with a decorative outline around the "I", "D", and "K". The name appears to be a signature or logo.

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

Enclosure

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Indications for Use

510(k) Number (if known): K122415

AREX USA X-FIX . Device Name:

The X-FIX is an external fixation system intended for use in the Indications for Use: treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.