The Arthrex Patella SuturePlates are manufactured from titanium alloy conforming to ASTM F136. The plates are 1.6 mm thick in a semi-contoured, mesh-like design. The plates are available in Arrow, Star and Star Pole configurations. Each plate provides locking screw fixation along with suture holes for fixation of the surrounding soft tissue to the plate. The Arthrex Patella SuturePlates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Patella SuturePlates are sold sterile and non-sterile and are single use.

AI/ML Overview

The acceptance criteria and study detailed in the provided document pertain to the Arthrex Patella SuturePlates, a medical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

This document describes the premarket notification for a Class II metallic bone fixation appliance, and the studies focus on demonstrating its substantial equivalence to previously cleared predicate devices through biomechanical, MRI safety, and biocompatibility testing. The "performance" being evaluated is essentially the physical and biological compatibility of the device.

However, I will extract the relevant information that is present in the document.

Acceptance Criteria and Reported Device Performance for Arthrex Patella SuturePlates

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are related to established engineering and biological standards and comparison to a predicate device, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biomechanical Performance	Demonstrate statistical equivalence to predicate devices (K201677, K170547) in:	The submitted mechanical testing data demonstrates that the ultimate tensile strength, stiffness, cyclic fatigue, bending strength, and bending structural stiffness of the proposed device is substantially equivalent to that of the predicate devices for the desired indications.
	- Ultimate Tensile Strength	Met (statistical equivalence shown)
	- Stiffness	Met (statistical equivalence shown)
	- Cyclic Fatigue	Met (statistical equivalence shown)
	- Bending Strength	Met (statistical equivalence shown)
	- Bending Structural Stiffness	Met (statistical equivalence shown)
	Testing methods: Tensile and cyclic testing, static four-point bend (ASTM F382)
MRI Safety and Compatibility	Conform to FDA guidance and ASTM standards for MRI environments:	Demonstrated MR Conditional labeling.
	- Magnetically Induced Displacement Force (ASTM F2052)	Met
	- Evaluation of MR Image Artifacts (ASTM F2119)	Met
	- Radio Frequency Induced Heating (ASTM F2182)	Met
	- Magnetically Induced Torque (ASTM F2213)	Met
Pyrogenicity	Meet pyrogen limit specifications.	The Arthrex Patella SuturePlates meet pyrogen limit specifications.
	Testing method: Bacterial Endotoxins Test (BET) utilizing Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14)
Biocompatibility	Conform to ISO 10993-1:2018 standards for:	All tests conducted (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, Material Characterization). Implies successful results as no issues were raised.
	- Cytotoxicity	Met (implicitly, no issues noted)
	- Sensitization	Met (implicitly, no issues noted)
	- Irritation	Met (implicitly, no issues noted)
	- Genotoxicity	Met (implicitly, no issues noted)
	- Systemic Toxicity	Met (implicitly, no issues noted)
	- Subchronic/Subacute Toxicity	Met (implicitly, no issues noted)
	- Implantation	Met (implicitly, no issues noted)
	- Material Characterization	Met (implicitly, no issues noted)
Sterilization & Shelf-Life	No additional risks/concerns introduced compared to predicate.	Assessment determined no additional risks or concerns.

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

Sample Size: Not explicitly stated in terms of number of devices or test repetitions for each specific test, other than implying sufficient samples were tested to demonstrate statistical equivalence for biomechanical tests.
Data Provenance: Not applicable as this relates to physical device testing, not patient data. The tests are laboratory-based.

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

Not applicable as this is a physical device submission; ground truth is established through standardized testing procedures and engineering/biological principles, not expert interpretation of data.

4. Adjudication method for the test set:

Not applicable. Performance is determined by meeting pre-defined test standards and demonstrating statistical equivalence to predicate devices, not through expert adjudication.

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. This is not an AI/ML device that assists human readers.

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

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

7. The type of ground truth used:

For Biomechanical Testing: Ground truth is established by mechanical engineering principles, established ASTM standards (e.g., ASTM F382), and comparative performance against the predicate device.
For MRI Safety: Ground truth is established by established ASTM standards (e.g., F2052, F2119, F2182, F2213) and FDA guidance for MRI environments.
For Pyrogenicity: Ground truth is established by biological testing standards (e.g., ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14) that define acceptable pyrogen limits.
For Biocompatibility: Ground truth is established by international standard ISO 10993-1:2018 "Biological evaluation of medical devices".

8. The sample size for the training set:

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

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

Not applicable. This is a physical device, not an AI/ML algorithm.

Summary

{0}------------------------------------------------

March 25, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. Rebecca Homan Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945

Re: K203834

Trade/Device Name: Arthrex Patella SuturePlates 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: December 23, 2020 Received: December 30, 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 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

{1}------------------------------------------------

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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K203834

Device Name

Arthrex Patella SuturePlates

Indications for Use (Describe)

The Arthrex Patella SuturePlates are intended for use in stabilization of patella fractures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Date Prepared	February 26, 2021
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanSenior Regulatory Affairs Specialist1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex Patella SuturePlates
Common Name	Plate, fixation, bone
Product Code	HRS, HWC, HTY
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K201677: Arthrex Mesh Plates
Reference Device	K170547: Arthrex Mesh Plate System
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Patella SuturePlates.
Device Description	The Arthrex Patella SuturePlates are manufactured from titanium alloyconforming to ASTM F136. The plates are 1.6 mm thick in a semi-contoured,mesh-like design. The plates are available in Arrow, Star and Star Poleconfigurations. Each plate provides locking screw fixation along with suture holesfor fixation of the surrounding soft tissue to the plate. The Arthrex PatellaSuturePlates are intended to be used with existing FDA cleared Arthrex screws.The Arthrex Patella SuturePlates are sold sterile and non-sterile and are singleuse.
Indications for Use	The Arthrex Patella SuturePlates are intended for use in stabilization of patellafractures.
Performance Data	Biomechanical (tensile and cyclic) and static four-point bend (ASTM F382) testingwas conducted to demonstrate that the Arthrex Patella SuturePlates performstatistically equivalent to the predicate devices cleared under K201677 andK170547.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.Bacterial Endotoxins Test (BET) was performed on the Arthrex PatellaSuturePlates utilizing the Kinetic Chromogenic Method in accordance withANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing
	conducted demonstrates that the Arthrex Patella SuturePlates meet pyrogen
	limit specifications.
	Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,
	Subchronic/Subacute Toxicity, Implantation and Material Characterization testing
	was conducted on the Arthrex Patella SuturePlates in accordance with ISO 10993-
	1:2018.
	Assessment of physical product attributes including product design, size, and
	materials as well as the conditions of manufacture and packaging has determined
	that the Arthrex Patella SuturePlates do not introduce additional risks orconcerns regarding sterilization and shelf-life.
TechnologicalComparison	The Arthrex Patella SuturePlates are substantially equivalent to the predicatedevices cleared under K201677and K170547 in which the basic design features,intended use, fundamental scientific technology, materials, sterility, packagingand shelf-life are identical.
	The Arthrex Patella SuturePlates are intended to be used with existing FDAcleared Arthrex screws (K103705, K111253, K123241, K143614, and K150456)with the optional use of the 4.0 mm Titanium Cannulated Screw (cleared underK103705 and K143614) to augment the patella fracture repair; whereas thepredicate Arthrex Mesh Plates and Arthrex Mesh Plate System are used withexisting FDA cleared Arthrex screws (K143614, K150456 and K170547) with theoptional use of the Arthrex Blunt Tip Screws (K143702) for patella fractures.
	The Arthrex Patella SuturePlates were evaluated for MR Conditional labeling aswere the predicate devices cleared under K201677.
	The Arthrex Patella SuturePlates are substantially equivalent to the predicatedevices cleared under K201677 and K170547, with minor dimensionalmodifications with no change to intended use or function. Any differencesbetween the Arthrex Patella SuturePlates and the predicate devices areconsidered minor and do not raise different questions of safety or effectiveness.
Conclusion	The Arthrex Patella SuturePlates are substantially equivalent to the predicatedevices in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise different questions concerning safety oreffectiveness.
	The submitted mechanical testing data demonstrates that the ultimate tensilestrength, stiffness, cyclic fatigue, bending strength and bending structuralstiffness of the proposed device is substantially equivalent to that of thepredicate 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 device.

{4}------------------------------------------------

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.