The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella fractures.

Device Description

The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The plates are available in long and short versions ranging from 50 mm to 115 mm in length. The plates are designed for the surgeon to cut to a desired length as needed. The Arthrex Mesh Plates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile and are single use.

AI/ML Overview

The document describes the acceptance criteria and supporting studies for the Arthrex Mesh Plates, a medical device, not an AI/ML product. Therefore, several points in your request related to AI/ML devices (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this submission.

Here's a breakdown of the available information regarding the acceptance criteria and studies for the Arthrex Mesh Plates:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Mechanical Performance (Tensile & Cyclic Testing)	Demonstrates that the Arthrex Mesh Plates perform statistically equivalent to the predicate device cleared under K143702. The ultimate tensile strength, stiffness, and cyclic fatigue of the proposed device are substantially equivalent to that of the predicate device for the desired indications.
MRI Safety (Force, Torque, Image Artifacts, Heating)	Conducted in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213. (Implies satisfactory performance for MR Conditional labeling).
Bacterial Endotoxins Test (BET)	Performed utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. Demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications.
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, and Material Characterization testing conducted in accordance with ISO 10993-1:2018. (Implies satisfactory biocompatibility).
Sterilization & Shelf-Life	Assessment of physical product attributes (design, size, materials, manufacturing conditions, packaging) determined that the Arthrex Mesh Plates do not introduce additional risks or concerns regarding sterilization and shelf-life. (Implies acceptable sterilization and shelf-life).
Substantial Equivalence	The Arthrex Mesh Plates are substantially equivalent to the predicate devices K17057 and K143702. Basic design features, intended use, fundamental scientific technology, materials, sterility, packaging, and shelf-life are identical or have minor differences that do not raise different questions of safety or effectiveness. Supported by mechanical testing and technological comparison.

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

Not Applicable. This information is typically relevant for AI/ML device studies. This submission pertains to a physical medical device (bone fixation plates). The mechanical and other tests would have specific sample sizes as per relevant ASTM/ISO standards, but these details are not provided in this summary.

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

Not Applicable. Ground truth, in the context of expert review, is typically relevant for AI/ML devices where human expert judgment is used to label data. For a physical device, performance is evaluated against engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not Applicable. Adjudication methods are typically used in clinical studies or for setting ground truth in AI/ML performance evaluation based on expert consensus.

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. MRMC studies are specific to AI/ML devices that assist human readers (e.g., radiologists interpreting images). This device is a surgical implant.

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

Not Applicable. This refers to AI/ML algorithm performance without human intervention, which is not relevant for a physical implantable device.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering standards, regulatory guidelines (e.g., FDA guidance for MR safety, ISO 10993 for biocompatibility), and direct mechanical testing against predicate device performance. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic device might be. The goal is to demonstrate equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not Applicable. "Training set" is a concept specific to AI/ML model development.

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

Not Applicable. This is specific to AI/ML model development.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

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

Re: K201677

Trade/Device Name: Arthrex Mesh 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, HTY Dated: June 15, 2020 Received: June 19, 2020

Dear Rebecca 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

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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,

On behalf of 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201677

Device Name Arthrex Mesh 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)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K201677 Page 1 of 2

510(k) Summary

Date Prepared	September 1, 2020
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	Rebecca R. Homan
	Regulatory Affairs Specialist
	1-239-643-5553, ext. 73429
	rebecca.homan@arthrex.com
Name of Device	Arthrex Mesh Plates
Common Name	Plate, fixation, bone
Product Code	HRS, HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances
	and accessories
Regulatory Class	II
Predicate Device	K170547: Arthrex Mesh Plate System (Primary Predicate)
	K143702: Arthrex Blunt Tip Screws with FiberTape (Secondary Predicate)
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance for
	patella fracture indications for the Arthrex Mesh Plates.
Device Description	The Arthrex Mesh Plates are manufactured from either titanium alloy or stainless
	steel. The plates are 1.3 mm thick in a semi-contoured, mesh-like design. The
	plates are available in long and short versions ranging from 50 mm to 115 mm in
	length. The plates are designed for the surgeon to cut to a desired length as
	needed. The Arthrex Mesh Plates are intended to be used with existing FDA
	cleared Arthrex screws. The Arthrex Mesh Plates are sold sterile and non-sterile
	and are single use.
Indications for Use	The Arthrex Mesh Plates are intended for use in stabilization of fresh fractures,
	revision procedures, osteotomies, joint fusion and reconstruction of small bones
	and bone fragments of the hand/wrist, foot/ankle, osteopenic bone and patella
	fractures.
Performance Data	Tensile and cyclic testing was conducted to demonstrate that the Arthrex Mesh
	Plates perform statistically equivalent to the predicate device cleared under
	K143702.
	MRI force, torque, and image artifact testing were conducted in accordance with
	FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic
	Resonance (MR) Environment, ASTM F2052 Standard Test Method for
	Measurement of Magnetically Induced Displacement Force on Medical Devices in
	the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for
	Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard
	Test Method for Measurement of Measurement of Radio Frequency Induced
	Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM
	F2213 Standard Test Method for Measurement of Magnetically Induced Torque
	on Medical Devices in the Magnetic Resonance Environment.
	Bacterial Endotoxins Test (BET) was performed on the Arthrex Mesh Plates
	utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI
	ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducted
	demonstrates that the Arthrex Mesh Plates meet pyrogen limit specifications.
	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterization testingwas conducted on the Arthrex Mesh Plates in accordance with ISO 10993-1:2018.
	Assessment of physical product attributes including product design, size, andmaterials as well as the conditions of manufacture and packaging has determinedthat the Arthrex Mesh Plates do not introduce additional risks or concernsregarding sterilization and shelf-life.
TechnologicalComparison	The Arthrex Mesh Plates are substantially equivalent to the predicate devicescleared under K170547 and K143702 in which the basic design features, intendeduse, fundamental scientific technology, materials, sterility, packaging and shelf-life are identical.
	The Arthrex Mesh Plates are used with existing FDA cleared Arthrex screws(K143614, K150456 and K170547) with the optional use of the Arthrex Blunt TipScrews (K143702) for patella fractures; whereas the predicate Arthrex Blunt TipScrews with FiberTape (K143702) consists of standalone screws used inconjunction with FiberTape Suture for patella fractures.
	The Arthrex Mesh Plates were evaluated for MR Conditional labeling; whereasthe predicate devices cleared under K170547 and K143702 were not evaluatedfor MR Conditional labeling.
	The Arthrex Mesh Plates are substantially equivalent to the predicate devicescleared under K170547 and K143702, with minor dimensional modifications withno change to intended use or function. Any differences between the ArthrexMesh Plates and the predicate devices are considered minor and do not raisedifferent questions of safety or effectiveness.
Conclusion	The Arthrex Mesh Plates are substantially equivalent to the predicate device inwhich the basic design features and intended uses are the same. Any differencesbetween the proposed device and the predicate device are considered minor anddo not raise different questions concerning safety or effectiveness.
	The submitted mechanical testing data demonstrates that the ultimate tensilestrength, stiffness and cyclic fatigue of the proposed device is substantiallyequivalent to that of the predicate device 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 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.