The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).

The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mimi Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).

Device Description

The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module consists of a series of plates and screws of varying lengths and thickness. The plates are contoured to fit the various aspects of the hand, wrist, foot and ankle including Straight, T-, Y-, V-, Cage, Triangular and Bridge. The plates are attached to bone with 2.0 mm and 2.4 mm cortical and variable locking screws. The screws range from 2.0 mm to 2.4 mm in diameter and from 6 mm to 40 mm in length. The plates and screws are manufactured from titanium. The plates and screws are sold non-sterile and single-use.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the "Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module." This device is a bone fixation system, consisting of plates and screws, intended for treating fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments.

The study presented in this document is a mechanical performance study designed to demonstrate substantial equivalence to a predicate device, not a study involving human subjects or AI-assisted interpretation of medical images. Therefore, many of the requested criteria (like sample size for test set, number of experts, reader studies, ground truth establishment for training, etc.) are not applicable in this context.

Here's a breakdown of the acceptance criteria and study as described in the document, focusing on what is relevant for a mechanical device submission:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence in mechanical performance to a legally marketed predicate device (K063049: Synthes (USA) Modular Mini Fragment LCP System). The performance data presented are for the mechanical properties of the device components (plates and screws).

Acceptance Criterion (Type of Test)	Reported Device Performance
Pull-out strength (ASTM F543)	"statistically equivalent to the predicate"
Insertion torque/failure torque	"statistically equivalent to the predicate"
Static four-point bend (ASTM F382)	"statistically equivalent to the predicate"
Four-point bend fatigue testing (ASTM F382)	"statistically equivalent to the predicate"

Summary of Conclusion: "The submitted mechanical testing data demonstrates that the pull-out, torque, bending strength and the fatigue strength of the proposed devices are substantially equivalent to that of the predicate device for the desired indications."

Details of the Study

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for each mechanical test. Mechanical tests typically involve a certain n number of samples per test type and comparison group (new device vs. predicate).
- Data Provenance: The data is generated from in vitro mechanical testing. The document does not specify the country of origin of the data beyond "Arthrex Inc." being located in Naples, Florida, USA. Since it's a mechanical test, the concept of "retrospective or prospective" as applied to clinical data is not directly applicable; it's a controlled laboratory study.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a mechanical device, and "ground truth" is established by direct physical measurement according to established ASTM standards, not by expert interpretation of images or clinical outcomes.
Adjudication Method for the Test Set:
- Not Applicable. As a mechanical test, there is no expert adjudication in the classic sense. The comparison to the predicate device would be based on statistical analysis of the measured mechanical properties.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is relevant for AI or imaging devices where human readers interpret medical images. This document describes mechanical testing of a bone fixation system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The Type of Ground Truth Used:
- The "ground truth" for this type of submission is the measured physical properties of the device and the predicate device according to standardized testing protocols (ASTM F543, ASTM F382). The goal is to show these physical properties are "substantially equivalent."
The Sample Size for the Training Set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
How the Ground Truth for the Training Set was Established:
- Not Applicable. As mentioned, this is not an AI/machine learning device.

In summary, this 510(k) submission relies on demonstrating the mechanical and material equivalence of the new bone fixation system to a predicate device through standardized in vitro laboratory testing, rather than clinical trials or AI performance evaluations.

Summary

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October 3, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.

Arthrex Inc. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K191344

Trade/Device Name: Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module 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: August 29, 2019 Received: August 30, 2019

Dear Rebecca R. Homan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191344

Device Name

Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary or 510(k) Statement

Date Prepared	August 29, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanSenior Regulatory Affairs Associate1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module
Common Name	Single/multiple component metallic bone fixation appliances and accessoriesSmooth or threaded metallic bone fixation fastener
Product Code	HRS; HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K063049: Synthes (USA) Modular Mini Fragment LCP System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module.
Device Description	The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Moduleconsists of a series of plates and screws of varying lengths and thickness. Theplates are contoured to fit the various aspects of the hand, wrist, foot and ankleincluding Straight, T-, Y-, V-, Cage, Triangular and Bridge. The plates are attachedto bone with 2.0 mm and 2.4 mm cortical and variable locking screws. Thescrews range from 2.0 mm to 2.4 mm in diameter and from 6 mm to 40 mm inlength. The plates and screws are manufactured from titanium. The plates andscrews are sold non-sterile and single-use.
Indications for Use	The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) areintended for fixation of fractures, osteotomies, nonunions, replantations, andfusions of small bones and small bone fragments, particularly in osteopenic bone.Examples include, but are not limited to, the hand, wrist, foot, and ankle. TheArthrex Mini Comprehensive Fixation System Plates are to be used with theArthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid).The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) areintended for fixation of fractures, osteotomies, nonunions, replantations, andfusions of small bones and small bone fragments, particularly in osteopenic bone.Examples include, but are not limited to, the hand, wrist, foot, and ankle. TheArthrex Mini Comprehensive Fixation System Screws are to be used with theArthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).
Performance Data	Pull-out (ASTM F543), insertion torque/failure torque, static four-point bend(ASTM F382) and four-point bend fatigue testing (ASTM F382) was conducted todemonstrate that the proposed Arthrex Mini Comprehensive Fixation System -2.0mm & 2.4mm Module performs statistically equivalent to the predicate.
Conclusion	The Arthrex Mini Comprehensive Fixation System - 2.0mm & 2.4mm Module issubstantially equivalent to the predicate device in which the basic design featuresand intended uses are the same. Any differences between the proposed deviceand the predicate device are considered minor and do not raise different
questions concerning safety or effectiveness.
The submitted mechanical testing data demonstrates that the pull-out, torque,bending strength and the fatigue strength of the proposed devices aresubstantially equivalent to that of the predicate device for the desiredindications.
Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device.

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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.