The Arthrex Ankle Fusion Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.

Device Description

The Arthrex Ankle Fusion Plating System is a family of implantable titanium plates and screws intended to be used for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, and fibula.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 91.9mm to 133.6mm. The accompanying screws are solid or cannulated, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 4.5mm to 6.7mm in diameter and 16mm to 120mm in length and include the partially threaded cannulated lag screws and 13mm washer previously cleared in K123241.
The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex, Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arthrex Ankle Fusion Plating System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics against ground truth. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can be extracted, and where the requested information is absent:

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

Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission aims to demonstrate "substantial equivalence" to the predicate device.
Reported Device Performance: The document states: "mechanical testing data demonstrates that the four-point bending, pull-out and insertion torque strength of the proposed Arthrex Ankle Fusion Plating System devices are substantially equivalent to or better than the four-point bending, pull-out and insertion torque strength of the predicate devices." No specific numerical values or comparison data are provided in this summary.

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

This information is not present in the provided document. The device is a physical orthopedic implant, and the evaluation mentioned is mechanical testing, not a clinical study involving human patients where "test set" and "data provenance" would be applicable in the sense of patient data.

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)

This information is not present. Ground truth in the context of mechanical testing would refer to established engineering standards or the performance of the predicate device, not expert human assessment.

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

This information is not present. Adjudication methods are typically used in clinical studies where human interpretation of data is involved, which is not the primary focus of this 510(k) summary.

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

This information is not present. This is a medical device for bone fixation, not an AI or imaging diagnostic tool. An MRMC study is irrelevant to this submission.

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

This information is not present. This is a physical implant, not an algorithm.

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

For a 510(k) submission of a bone fixation device, the "ground truth" for demonstrating substantial equivalence is typically based on mechanical testing against established engineering standards or the performance of the predicate device. The document refers to "mechanical testing data" for "four-point bending, pull-out and insertion torque strength."

8. The sample size for the training set

This information is not present. A "training set" is relevant for machine learning algorithms, not for physical medical implants undergoing mechanical testing for substantial equivalence.

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

This information is not present for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a bone fixation device, which focuses on demonstrating substantial equivalence through mechanical testing rather than presenting a clinical study with detailed acceptance criteria, ground truth establishment, or clinical performance metrics as would be seen for a diagnostic or AI-driven device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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

August 15, 2014

Arthrex, Inc. Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K141735

Trade/Device Name: Arthrex Ankle Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, HTN Dated: July 18, 2014 Received: July 22, 2014

Dear Ms. Medlin:

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

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Page 2 – Ms. Laura Medlin

(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 (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/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,

Lori A. Wiggins -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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141735

Device Name Arthrex Ankle Fusion Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 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)

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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Indications for Use

Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141735

Device Name Arthrex Ankle Fusion Plating System

Indications for Use (Describe)

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plating System.

Type of Use (Select one or both, as applicable)

2 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)

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.

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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510(k) Summary of Safety and Effectiveness

Date Summary Prepared	August 12, 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Laura MedlinRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72005Fax: 239/598.5508Email: Laura.Medlin@Arthrex.com
Trade Name	Arthrex Ankle Fusion Plating System
Common Name	Plate, fixation, boneScrew, fixation, bone
Product Code	HWC, HTN, HRS
Classification Name / CFR	21 CFR 888.3030 – Single/multiple component metallicbone fixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener
Predicate Device	K123241: Arthrex Fracture Plates
Purpose of Submission	This special 510(k) premarket notification is submitted toobtain clearance for the Arthrex Ankle Fusion PlatingSystem.
Device Description andIntended Use	The Arthrex Ankle Fusion Plating System is a family ofimplantable titanium plates and screws intended to beused for internal bone fixation for bone fractures, fusions,osteotomies, and non-unions in the ankle, foot, hand,wrist, clavicle, scapula, olecranon, humerus, radius, ulna,tibia, calcaneous, and fibula.The subject plates are contoured and may be available in
	left and right configurations, ranging in length from91.9mm to 133.6mm. The accompanying screws are solidor cannulated, fully or partially threaded, and may belocking or non-locking. The proposed screw offeringsubject of this application are 4.5mm to 6.7mm indiameter and 16mm to 120mm in length and include thepartially threaded cannulated lag screws and 13mmwasher previously cleared in K123241.
	The Arthrex Low Profile Screws (2.5mm and larger, solid)are intended to be used as stand-alone bone screws, or ina plate-screw system for internal bone fixation for bonefractures, fusions, osteotomies, and non-unions in theankle, foot, hand, and wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneous, femur, andfibula. When used with a plate, the screws may be usedwith the Arthrex, Low Profile, Small Fragment Plates,Fracture Plates, Distal Extremity Plates, Humeral FracturePlates, Osteotomy Plates, and Ankle Fusion PlatingSystem.
Substantial Equivalence Summary	Based on the intended use, technological characteristicsand comparison to the predicate devices, Arthrex, Inc.has determined that the Arthrex Ankle Fusion PlatingSystem is substantially equivalent to the currentlymarketed predicate devices, Arthrex Fracture Plates(K123241).
	The implant materials are the same as the predicatedevices. Further, mechanical testing data demonstratesthat the four-point bending, pull-out and insertion torquestrength of the proposed Arthrex Ankle Fusion PlatingSystem devices are substantially equivalent to or betterthan the four-point bending, pull-out and insertiontorque strength of the predicate devices. Any differencesbetween the Arthrex Ankle Fusion Plating System andthe predicates are considered minor and do not raisequestions concerning safety and effectiveness.

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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.