The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates.

The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrex Low Profile Screws (3.5mm 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 and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, femur, and fibula.

Device Description

The Arthrex Low Profile Screws are titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. The screws range from 2.0mm to 4.0mm in diameter and in length from 8mm to 80mm.

AI/ML Overview

This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws". It details the device, its intended use, and its substantial equivalence to a predicate device. The purpose of the submission is primarily for sterilization method clearance and line extensions, rather than proving performance against acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML or comparative effectiveness, MRMC studies, or standalone algorithm performance, is not available in the provided document.

This document describes a traditional medical device (bone screws) and its regulatory submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data from a new clinical study with acceptance criteria.

However, I can extract information related to the device itself and its regulatory context:

1. A table of acceptance criteria and the reported device performance:
* Not applicable / Not provided. This document is a 510(k) submission based on substantial equivalence, not a clinical trial demonstrating performance against specific acceptance criteria. The "performance" assessment is based on the new device having similar design, materials, and intended use as the predicate device.

2. Sample size used for the test set and the data provenance:
* Not applicable / Not provided. No specific test set or data provenance from a clinical study is included in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable / Not provided. Ground truth establishment, as typically required for AI/ML device studies, is not part of this 510(k) submission for bone screws.

4. Adjudication method for the test set:
* Not applicable / Not provided.

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 / Not provided. This is not a study for an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable / Not provided. This is not an algorithm-only device; it is a physical medical device.

7. The type of ground truth used:
* Not applicable / Not provided. The basis for clearance is substantial equivalence to a predicate device, not empirical ground truth data from a new study.

8. The sample size for the training set:
* Not applicable / Not provided. There is no "training set" in the context of this traditional medical device submission.

9. How the ground truth for the training set was established:
* Not applicable / Not provided.

Information that is present in the document:

Device Name: Arthrex Low Profile Screws
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II
Product Code: HWC, HRS
Predicate Device: K103705: Arthrex Low Profile Screws
Purpose of Submission:
- To obtain FDA clearance for the use of Gamma Irradiation and Ethylene Oxide sterilization for the Arthrex Low Profile Screws (which were previously cleared as non-sterile through K103705).
- To address the addition of 3.75mm Low Profile Screws and Low Profile Variable Angle Locking Screws as line extensions, being similar in design, identical in material, and intended use to the cleared predicate.
Device Description: Titanium or stainless steel, fully or partially threaded, solid or cannulated, self-tapping, headed screws. Range from 2.0mm to 4.0mm in diameter and 8mm to 80mm in length.
Intended Use (summarized): Internal bone fixation for fractures, fusions, osteotomies, and non-unions in various anatomical locations (ankle, foot, hand, wrist for smaller sizes; adding clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula for larger sizes), either as stand-alone screws or in a plate-screw system.
Basis for Substantial Equivalence: The new screws are stated to be substantially equivalent to the predicate device because "the basic design features and intended uses are the same. Any differences... are considered minor and do not raise questions concerning safety and effectiveness." The new sterilization methods and expanded sizes are also deemed to be within acceptable parameters when compared to the predicate.

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 is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.

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

January 16, 2015

Arthrex, Inc. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K143614

Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: December 22, 2014 Received: December 23, 2014

Dear Mr. Rogers:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. David L. Rogers

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 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 vours.

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143614

Device Name

Arthrex Low Profile Screws

Indications for Use (Describe)

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)

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)

FORM FDA 3881 (9/13)

PSC Publishing Services (301) 443-6

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2.6 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Date Summary Prepared	October 8, 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	David L RogersRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@Arthrex.com
Trade Name	Arthrex Low Profile Screws
Common Name	Screw, fixation, bone
Product Code -Classification Name	HWC - Screw, Fixation, BoneHRS - Plate, Fixation, Bone
CFR	21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Predicate Device	K103705: Arthrex Low Profile Screws
Purpose of Submission	This special 510(k) premarket notification is submitted toobtain FDA clearance for the use of Gamma Irradiation andEthylene Oxide sterilization for the Arthrex Low Profile Screwswhich were cleared as non-sterile devices through K103705.This special 510(k) premarket notification is also intended toaddress the addition of 3.75mm Low Profile Screws and LowProfile Variable Angle Locking Screws as line extensions to thecleared predicate, which are similar in design and identical inmaterial and intended use.
Device Description	The Arthrex Low Profile Screws are titanium or stainless steel,fully or partially threaded, solid or cannulated, self-tapping,headed screws. The screws range from 2.0mm to 4.0mm indiameter and in length from 8mm to 80mm.
Intended Use	The Arthrex Low Profile Screws (2.0-3.0mm solid) are intendedto be used as stand-alone bone screws, or in a plate screwsystem for internal bone fixation for bone fractures, fusions,osteotomies, and non-unions in the ankle, foot, hand, andwrist. When used with a plate, the screw may be used with theArthrex Low Profile and Small Fragment Plates.
	The Arthrex Low Profile Screws (2.0-3.0mm cannulated) areintended to be used as stand-alone bone screws for internalbone fixation for bone fractures, fusions, osteotomies, andnon-unions in the ankle, foot, hand, and wrist.
	The Arthrex Low Profile Screws (3.5mm and larger, solid) areintended 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,wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia,calcaneous, femur, and fibula. When used with a plate, thescrews may be used with the Arthrex Low Profile and SmallFragment Plates, Humeral Fracture Plates, and OsteotomyPlates.
	The Arthrex Low Profile Screws (3.5mm and larger,cannulated) are intended to be used as stand-alone bonescrews 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, femur, and fibula.
Substantial Equivalence Summary	The Arthrex Low Profile Screws are substantially equivalent tothe predicate devices in which the basic design features andintended uses are the same. Any differences between theArthrex Low Profile Screws and the predicates are consideredminor and do not raise questions concerning safety andeffectiveness.
	The predicate screws are non-sterile. The proposed plates andscrews will undergo Gamma Irradiation or Ethylene Oxide (EO)sterilization.
	The new 3.75mm Low Profile Screws and Low Profile VariableAngle Locking Screws are within the cleared size range ofpredicate K103705.
	Based on the indications for use, technological characteristics,and the summary of data submitted, Arthrex, Inc. hasdetermined that the Arthrex Low Profile Screws aresubstantially equivalent to the predicates.

2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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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.