The Arthrex Mini Fragment System is indicated for fracture fixation, replantation, stabilization, reduction, fusions, osteotomies, mal-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Device Description

The proposed Arthrex Mini Fragment System consists of a series of plates and screws of varying lengths and thicknesses. Each plate provides locking screw fixation. The proposed screws are a family of locking and non-locking screws. The proposed plates and screws are manufactured from Titanium Alloy. The proposed plates and screws are sold non-sterile and single-use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Arthrex Mini Fragment System. This document focuses on the mechanical and material performance of the device compared to a predicate device, rather than the performance of an AI/ML-driven diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML device performance (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this submission.

The acceptance criteria and study proving the device meets them are based on bench testing (mechanical and MRI compatibility), demonstrating substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the available information relevant to your request, with an emphasis on why certain sections are not applicable in this context:

Acceptance Criteria and Device Performance (for a Mechanical Fixation System)

The "acceptance criteria" for the Arthrex Mini Fragment System are demonstrated by showing that its mechanical performance is statistically equivalent to the predicate device, and that it meets established MRI safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test and Standard	Reported Device Performance
Mechanical Performance	Static 4-Point Bend (ASTM F382-17)	"demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412."
	4-Point Fatigue Bend (ASTM F382-17)	"demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412."
	Pull-out (ASTM F543-17)	"demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412."
	Failure Torque	"demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412."
	Insertion Torque (ASTM F543-17)	"demonstrates that the Arthrex Mini Fragment System performs statistically equivalent to the predicate Stryker VariAx 2 Mini Fragment System, K191412."
MRI Compatibility	Magnetic Resonance (MR) Environment Testing (FDA Guidance, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) covering:	"MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance..." and "The Arthrex Mini Fragment System was evaluated for MR Conditional labeling..." implying successful completion.
	- Magnetically Induced Displacement Force (ASTM F2052)	Specific numerical results not provided in the summary but indicated as acceptable.
	- MR Image Artifacts (ASTM F2119)	Specific numerical results not provided in the summary but indicated as acceptable.
	- Radio Frequency Induced Heating (ASTM F2182)	Specific numerical results not provided in the summary but indicated as acceptable.
	- Magnetically Induced Torque (ASTM F2213)	Specific numerical results not provided in the summary but indicated as acceptable.

Information Not Applicable or Not Provided for a Mechanical Device:

Sample size used for the test set and the data provenance: Not applicable. This refers to the number of physical test specimens used for bench testing, not a "test set" of patient data for AI/ML. The document does not specify the number of samples tested for each mechanical or MRI test, nor data provenance (as it's bench data, not clinical data).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is established by engineering specifications, material science, and physical testing standards.
Adjudication method for the test set: Not applicable. There is no human interpretation of a test set in this context.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for mechanical implants.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: For mechanical performance, the "ground truth" is defined by the established ASTM standards and the performance of the predicate device. For MRI compatibility, it is defined by the specific ASTM standards and FDA guidance. This is not "expert consensus, pathology, or outcomes data" in the typical sense of medical diagnostics.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established: Not applicable. Since there's no training set, there's no ground truth to establish for it.

Summary

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June 29, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Arthrex Inc. Stacy Valdez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K220937

Trade/Device Name: Arthrex Mini Fragment 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 Dated: March 18, 2022 Received: March 31, 2022

Dear Stacy Valdez:

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

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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) 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 (OS) 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 mediation-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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220937

Device Name Arthrex Mini Fragment System

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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K220937 510(k) Summary

Date Prepared	June 28, 2022
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Stacy ValdezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 72010Stacy.valdez@arthrex.com
Name of Device	Arthrex Mini Fragment System
Common Name	Plate, fixation, bone
Product Code	HRS (Primary), HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixationappliances and accessories (Primary)21 CFR 888.3040: Smooth or threaded metallic bone fastener
Regulatory Class	II
Primary Predicate Device	K191412: VariAx 2 Mini Fragment System
Additional Predicate Device	K191344: Arthrex Mini Comprehensive Fixation System - 2.0 & 2.4 ModuleK140814: Smith & Nephew EVOS Mini-Fragment Plating System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtainclearance for the Arthrex Mini Fragment System.
Device Description	The proposed Arthrex Mini Fragment System consists of a series of platesand screws of varying lengths and thicknesses. Each plate provides lockingscrew fixation. The proposed screws are a family of locking and non-locking screws. The proposed plates and screws are manufactured fromTitanium Alloy. The proposed plates and screws are sold non-sterile andsingle-use.
Indications for Use	The Arthrex Mini Fragment System is indicated for fracture fixation,reconstruction, replantation, stabilization, reduction, fusions, osteotomies,mal-unions, and non-unions of small bones and small bone fragmentsincluding normal and osteopenic bones in adult and adolescent (12-21years) patients. The system is also indicated for non-load bearingstabilization and reduction of bone fragments in long bones.
Performance Data	Arthrex conducted Static 4-Point Bend (ASTM F382-17), 4-Point FatigueBend (ASTM F382-17), Pull-out (ASTM F543-17), Failure Torque, InsertionTorque (ASTM F543-17) and testing to demonstrate that the Arthrex MiniFragment System performs statistically equivalent to the predicate StrykerVariAx 2 Mini Fragment System, K191412.MRI force, torque, and image artifact testing were conducted inaccordance with FDA guidance Testing and Labeling Medical Devices forSafety in the Magnetic Resonance (MR) Environment, ASTM F2052Standard Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the Magnetic ResonanceEnvironment, ASTM F2119 Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants, ASTM F2182 Standard Test Methodfor Measurement of Measurement of Radio Frequency Induced HeatingNear Passive Implants During Magnetic Resonance Imaging and ASTMF2213 Standard Test Method for Measurement of Magnetically Induced
	Torque on Medical Devices in the Magnetic Resonance Environment.
Technological Comparison	The Arthrex Mini Fragment System is substantially equivalent to thepredicate devices cleared under K191412 in which the basic designfeatures, intended use, fundamental scientific technology, shelf-life, andsterility are identical.The Arthrex Mini Fragment System is manufactured from Titanium Alloyconforming to ASTM F136 (for Plates) and ASTM F136/F1472 (for Screws).The primary predicate plates and screws cleared under the Stryker VariAx2 Mini Fragment System, K191412 are manufactured from titanium alloyand unalloyed titanium (standards unknown). The proposed Arthrex MiniFragment System plates are offered in lengths ranging from 35.2 – 141.1mm. The primary predicate plates cleared under the Stryker VariAx 2 MiniFragment System, K191412 are offered in lengths ranging from 22 – 176mm. The proposed Arthrex Mini Fragment System screws are offered indiameters of 2.0 mm, 2.4mm, and 2.7 mm. The primary predicate screwscleared under the Stryker VariAx 2 Mini Fragment System, K191412 areoffered in diameters of 2.0 mm, 2.4 mm, and 2.7 mm.The Arthrex Mini Fragment System was evaluated for MR Conditionallabeling as were the predicate device cleared under K191412.The Arthrex Mini Fragment is substantially equivalent to the predicatedevices cleared under K191412, with minor modifications with no changeto intended use or function. Any differences between the Arthrex MiniFragment System and the predicate devices are considered minor and donot raise different questions of safety or effectiveness.
Conclusion	The Arthrex Mini Fragment System is substantially equivalent to thepredicate devices cleared under K191412 in which the basic designfeatures and intended use are the same. Any differences between theArthrex Mini Fragment System and the predicate devices are consideredminor and do not raise different questions of safety or effectiveness.The submitted mechanical testing data demonstrates that the Static 4-Point Bend Strength, 4-Point Bend strength, Pull-Out and FailureTorque/Insertion Torque of the Arthrex Mini Fragment System issubstantially equivalent to that of the predicate device for the desiredindications.Based on the indications for use, technological characteristics, and thesummary of data submitted, Arthrex Inc. has determined that theproposed device is substantially equivalent to the currently marketedpredicate devices.

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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.