Arthrex 3.5 mm Locking Compression Plates by Arthrex Inc.

The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

Device Description

The Arthrex 3.5 mm Locking Compression Plates consists of a series of varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: Arthrex 3.5 mm Locking Compression Plates (K222244). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered diagnostic device meets specific performance criteria.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, is not present in this document. This is because the device described is a physical implant (bone fixation plates), not an AI/medical imaging diagnostic system.

The document describes material testing and mechanical performance to demonstrate equivalence between the new plates and existing predicate devices.

Here's a breakdown of the relevant information provided in the document:

Device Type: Arthrex 3.5 mm Locking Compression Plates – a physical metallic implant for bone fixation.
Purpose of Submission: To obtain 510(k) clearance for the new plates by demonstrating substantial equivalence to a predicate device (K123241: Arthrex Fracture Plates).
Performance Data: The document mentions physical and mechanical testing, not AI model performance.
- 4-Point Bend Testing (ASTM F382-17): Conducted to demonstrate statistical equivalence in strength to the predicate device.
- MRI Force, Torque, and Image Artifact Testing: Performed in accordance with FDA guidance and ASTM standards (e.g., ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) to evaluate MR compatibility.
- Bacterial Endotoxins Test (BET): Utilizes the Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14) to confirm pyrogen limit specifications for sterile devices.
No AI, Machine Learning, or Diagnostic Study Details: The document does not contain any information about the acceptance criteria or studies typically associated with AI/ML-driven diagnostic devices. There is no mention of:
- Sensitivity, Specificity, AUC, or other diagnostic performance metrics.
- Test/training data sets, their sizes, or provenance.
- Expert involvement in establishing ground truth for diagnostic purposes.
- Adjudication methods.
- MRMC studies.
- Standalone algorithm performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device (bone plates) and therefore does not contain the information required to answer the prompt regarding AI device acceptance criteria and studies.

Summary

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September 30, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K222244

Trade/Device Name: Arthrex 3.5 mm Locking Compression 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: July 25, 2022 Received: July 26, 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 (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 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/cdrl-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, 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)

K222244

Device Name Arthrex 3.5 mm Locking Compression 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)

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510(k) Summary

Date Prepared	September 26, 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 3.5 mm Locking Compression Plates
Common Name	Plate, fixation, bone
Product Code	HRS, HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories (Primary)21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K123241: Arthrex Fracture Plates
Reference Device(s)	K203294: Arthrex Pilon Fusion SystemK151732: Arthrex Fracture Plates
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex 3.5 mm Locking Compression Plates.
Device Description	The Arthrex 3.5 mm Locking Compression Plates consists of a series ofvarying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70mm to 278 mm in length and 3.5 mm in thickness. Each plate provides lockingscrew fixation. The proposed plates are manufactured from Titanium Alloy (ASTMF136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile(Gamma), single-use, and non-sterile, single-use.
Indications for Use	The Arthrex 3.5 mm Locking Compression Plates are intended to be used forinternal bone fixation for bone fractures, fusions, osteotomies and non-unions inthe ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia,calcaneous, fibula.
Performance Data	Arthrex conducted 4-Point Bend (ASTM F382-17) testing to demonstrate that theArthrex 3.5 mm Locking Compression Plates perform statistically equivalent tothe predicate devices cleared under Arthrex Fracture Plates (K123241).MRI force, torque, and image artifact testing were conducted in accordance withFDA guidance Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Force on Medical Devices inthe Magnetic Resonance Environment, ASTM F2119 Standard Test Method forEvaluation of MR Image Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of Radio Frequency InducedHeating Near Passive Implants During Magnetic Resonance Imaging and ASTMF2213 Standard Test Method for Measurement of Magnetically Induced Torqueon Medical Devices in the Magnetic Resonance Environment.Arthrex Plates are tested for Bacterial Endotoxins Test (BET) utilizing the KineticChromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP<161>, USP <85>, EP 2.6.14. The testing conducted demonstrates that the steriledevices within the Arthrex Plates meet pyrogen limit specifications.

	Assessment of physical product attributes including product, design, size, andmaterials has determined that the Arthrex 3.5 mm Locking Compression Platesdo not introduce additional risks or concerns regarding sterilization and shelf-life.
TechnologicalComparison	The Arthrex 3.5 mm Locking Compression Plates are substantially equivalent tothe predicate devices cleared under K123241 in which the basic design features,intended use, fundamental scientific technology, materials (stainless steel only),shelf-life, and sterility are identical.
	The Arthrex 3.5 mm Locking Compression Plates are manufactured from TitaniumAlloy conforming to ASTM F136 and Stainless Steel conforming to ASTM F138.The primary predicate plates cleared under the Arthrex Fracture Plates, K123241are manufactured from CP Grade 4 Titanium conforming to ASTM F67 andStainless Steel conforming to ASTM F138. The proposed Arthrex 3.5 mm LockingCompression Plates are 3.5 mm in thickness and range from 70 mm to 278 mm inlength. The primary predicate plates cleared under the Arthrex Fracture Plates,K123241 are offered in thicknesses ranging from 1.0 mm to 2.0/3.6 mm.
	The sterile Arthrex 3.5 mm Locking Compression Plates are packaged in a doubleNylon/Nylon pouch which is equivalent to the packaging configuration clearedunder reference device Arthrex Pilon Fusion System, K203294. The non-sterileArthrex 3.5 mm Locking Compression Plates are packaged in a Zip-LockPolyethylene Bag or a single Polyethylene Bag. The primary predicate platescleared under Arthrex Fracture Plates, K123241 are packaged in a polyethylenepouch.
	The Arthrex 3.5 mm Locking Compression Plates were evaluated for MRConditional labeling as were the reference predicate devices cleared underK203294.
	The 3.5 mm Locking Compression Plates are substantially equivalent to thepredicate devices cleared under K123241, with minor modifications with nochange to intended use or function. Any differences between the Arthrex 3.5 mmLocking Compression Plates and the predicate devices are considered minor anddo not raise different questions of safety or effectiveness.
Conclusion	The Arthrex 3.5 mm Locking Compression Plates are substantially equivalent tothe predicate devices cleared under K123241 in which the basic design featuresand intended use are the same. Any differences between the Arthrex 3.5 mmLocking Compression Plates and the predicate devices are considered minor anddo not raise different questions of safety or effectiveness.
	The submitted mechanical testing data demonstrates that the 4-Point Bendstrength of the Arthrex 3.5 mm Locking Compression Plates are substantiallyequivalent to that of the predicate devices for the desired indications.
	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 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.