The Arthrex Fracture Plates are 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 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, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

Device Description

The Arthrex Fracture Plates are a family of flat and contoured plates and screws. The plates are comprised of stainless steel and come in a variety of configurations. The Arthrex Fracture Plates are intended to be used with solid locking and non-locking Low Profile Screws. The proposed Low Profile Screws, in this submission, are comprised of Stainless Steel and are 2.7mm in diameter and range from 32mm to 60mm in length.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Arthrex Fracture Plates and accompanying screws. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML study description (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this document. The document describes a mechanical performance study to demonstrate substantial equivalence.

Here's the information that can be extracted relevant to acceptance criteria and the "study" conducted for this type of device:

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

The document describes material and mechanical testing to demonstrate substantial equivalence. It implies that the acceptance criteria for these tests were met by being comparable to the predicate devices. The specific raw data or numerical acceptance limits are not provided in this summary, but the conclusion of meeting them is stated.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
4-point bend	Performance comparable to predicate devices	Performance is substantially equivalent to predicate devices
Section modulus comparison	Performance comparable to predicate devices	Performance is substantially equivalent to predicate devices
Torque	Performance comparable to predicate devices	Performance is substantially equivalent to predicate devices

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated for the mechanical tests in this summary. Mechanical tests typically involve a small number of samples of the device and predicate.
Data provenance: The tests were "in-vitro testing" conducted by the manufacturer, Arthrex, Inc., in the USA (Naples, FL).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This pertains to mechanical testing, not expert-based evaluation of medical images.

4. Adjudication method for the test set:

Not applicable. This pertains to mechanical testing.

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:

No. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

Mechanical properties comparison to predicate devices. The "ground truth" here is the established mechanical performance of legally marketed predicate devices, against which the new device's performance is compared.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of what the document does say about the "study":

The study conducted was in-vitro mechanical testing (4-point bend, section modulus comparison, torque) to compare the performance of the Arthrex Fracture Plates and screws to their predicate devices. The conclusion was that the "performance of the proposed devices is substantially equivalent to that of the predicate devices" and that "The mechanical data indicate that the Arthrex Fracture Plates are adequate for their intended use." The document explicitly states: "Clinical data and conclusions are not needed for this device."

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and appear to be connected by flowing lines at the bottom. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

August 28, 2015

Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K151732 Trade/Device Name: Arthrex Fracture Plates 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 Dated: June 20, 2015 Received: July 31, 2015

Dear Ms. Smith:

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,

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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Appendix 1

2.5 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K151732

Device Name

Arthrex Fracture Plates

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
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

PSC Publishing Services (301) 443-6740 EP

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Date Summary Prepared	August 20, 2015
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Courtney SmithManager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext.71720Fax: 239/598.5508Email: Courtney.Smith@Arthrex.com
Trade Name	Arthrex Fracture Plates
Common Name	Plate, fixation, bone
Product Code,Classification Name, CFR	HWC, HRS21 CFR 888.8030: Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Predicate Device	K123241 - Arthrex Fracture PlatesK141478 - Arthrex Fracture Plates and Screws
Purpose of Submission	This special 510(k) premarket notification is submitted to obtainclearance for Arthrex Fracture Plates and the accompanyingscrews.
Device Description	The Arthrex Fracture Plates are a family of flat and contouredplates and screws. The plates are comprised of stainless steel andcome in a variety of configurations. The Arthrex Fracture Plates areintended to be used with solid locking and non-locking Low ProfileScrews. The proposed Low Profile Screws, in this submission, arecomprised of Stainless Steel and are 2.7mm in diameter and rangefrom 32mm to 60mm in length.
Intended Use	The Arthrex Fracture Plates are intended to be used for internal bone
	fixation for bone fractures, fusions, osteotomies and non-unions inthe ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus,radius, ulna, tibia, calcaneous, and fibula.
	The Arthrex Low Profile Screws (2.5mm and larger, solid) areintended to 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, wrist, clavicle,scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femurand fibula. When used with a plate, the screws may be used with theArthrex Low Profile, Small Fragment Plates, Fracture Plates, DistalExtremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
SubstantialEquivalence Summary	The Arthrex Fracture Plates are substantially equivalent to thepredicate devices in which the basic design features and intendeduses are the same. Any differences between the Arthrex FracturePlates and the predicates are considered minor and do not raisequestions concerning safety and effectiveness.
	The proposed devices are substantially equivalent to the predicatedevices in regards to its intended use, design, size range, andmaterial. The submitted in-vitro testing (4-point bend, sectionmodulus comparison, torque) demonstrates that the performanceof the proposed devices is substantially equivalent to that of thepredicate devices. The mechanical data indicate that the ArthrexFracture Plates are adequate for their intended use. Clinical dataand conclusions are not needed for this device.
	Based on the indication for use, technological characteristics, andthe comparison to the predicate device, Arthrex, Inc. hasdetermined that the Arthrex Fracture Plates are substantiallyequivalent to currently marketed predicate devices.

2.5 510K SUMMARY OF 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.