The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.

The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screws may be used with the Arthrex Low Profile Plates, Small Fragment Plates and MaxForce MTP Compression Plates.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plates, Small Fragment Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.

Device Description

The Arthrex MaxForce MTP Compression Plates and Screws consists of a series of plates and screws of varying lengths and diameters. The plates are contoured to fit the various aspects of the metatarsals including Petite, Standard, Long, X-Long and Revision with 0° and 5° Valgus and Dorsiflex in left and right configurations. The plates are manufactured from titanium alloy conforming to ASTM F136. The plates are attached to bone with 3.0 mm cortical, 3.0 mm cortical, hybrid and 3.0 mm variable locking screws. The screws range from 3.0 mm to 3.5 mm in diameter and from 10 mm to 26 mm in length. The screws are manufactured from titanium alloy conforming to ASTM F136. 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, specifically the Arthrex MaxForce MTP Compression Plates and Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device safety and effectiveness through clinical studies with acceptance criteria in the traditional sense (e.g., diagnostic accuracy metrics like sensitivity/specificity).

Instead, "acceptance criteria" for such a device would typically refer to meeting engineering and mechanical performance benchmarks, demonstrating that the new device is as safe and effective as its predicate. The "study" proving this largely consists of bench testing.

Here's a breakdown of the information based on the provided text, aligning it with your request where applicable, and highlighting what's not present (which is common for this type of device submission):

Acceptance Criteria and Device Performance Study for Arthrex MaxForce MTP Compression Plates and Screws

For implantable orthopedic hardware like the Arthrex MaxForce MTP Compression Plates and Screws, the "acceptance criteria" are primarily established through direct comparison to legally marketed predicate devices and by meeting engineering and mechanical performance standards outlined in relevant ASTM (American Society for Testing and Materials) standards. The "study" consists of a series of bench tests.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance
Mechanical Performance	Static Four-Point Bend (ASTM F382)	Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705).
	Four-Point Bend Fatigue (ASTM F382)	Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705).
	Plate/Instrument Compression Testing (Compression Force, Compression Distance)	Performed. Demonstrates statistical equivalence to predicate devices.
	Screw Pull-out strength testing (ASTM F543)	Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705).
	Screw Torsional strength testing (ASTM F543)	Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705).
	Screw Insertion Torque testing	Performed. Demonstrates statistical equivalence to predicate devices.
MRI Compatibility	MRI force (ASTM F2052)	Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates.
	Magnetically Induced Torque (ASTM F2213)	Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates.
	Image Artifacts (ASTM F2119)	Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates.
	Radio Frequency Induced Heating (ASTM F2182)	Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates.
Material Equivalence	Comparison of material (Titanium alloy conforming to ASTM F136 vs. stainless steel for one predicate, titanium alloy for another)	The titanium alloy used is identical to the titanium alloy cleared for a predicate (K111253), addressing the difference with the stainless steel predicate. Differences are considered minor and do not raise different questions concerning safety or effectiveness.
Design/Intended Use	Comparison of basic design features, intended use, fundamental scientific technology, indications for use, sterility, packaging, and shelf-life to predicate devices. Dimensions (lengths, diameters, contours) are compared to predicates where relevant.	Overall, the device is substantially equivalent to predicate devices. Minor differences in plate contours (e.g., Petite, Standard, Long, X-Long vs. Square, Linear, T-configurations or Petite, Standard, Long) and material (stainless steel in one predicate vs. titanium in the proposed device and another predicate) are noted but found not to raise different questions of safety or effectiveness. Indications for use are consistent with or encompass those of the predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in terms of "test set" as this refers to physical samples (e.g., plates and screws) subjected to mechanical and MRI testing. The tests are typically performed on a sufficient number of samples to ensure statistical validity for the properties being measured. The specific number of physical units tested for each mechanical or MRI compatibility test is not detailed in this summary.
Data Provenance: The data is generated from bench testing (laboratory experiments) conducted by the manufacturer (Arthrex Inc.). This is prospective in the sense that the tests were specifically performed for this submission. Country of origin for the data generation would be the location of the manufacturing and testing facilities, implied to be in the USA (Naples, FL).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. There is no "ground truth" expert review in the sense of clinical image interpretation or diagnosis. The "ground truth" for these tests is based on established engineering principles, ASTM standards, physics of materials, and comparison to the performance of predicate devices. The "experts" involved are likely engineers and scientists performing the tests and analyzing the results against these established benchmarks and predicate data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to clinical studies involving human interpretation or diagnosis where discrepancies need to be resolved. Bench tests do not involve this type of 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 device is an orthopedic implant, not an AI-based diagnostic tool. MRMC studies are used for evaluating diagnostic performance, often with AI assistance, which is not relevant here.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Adherence to well-defined engineering standards (e.g., ASTM F382, ASTM F543, ASTM F2052, F2119, F2182, F2213).
Performance data from legally marketed predicate devices (K130510, K111253, K103705), which themselves have established safety and effectiveness.
Material specifications (ASTM F136 for titanium alloy).
Physical laws (for MRI compatibility testing).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires training data.

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

Not applicable, as there is no training set for this type of device.

Summary

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

Re: K201235

Trade/Device Name: Arthrex MaxForce MTP Compression Plates and Screws 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: May 4, 2020 Received: May 7, 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

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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/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

Shumava 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) K201235

Device Name

Arthrex MaxForce MTP Compression Plates and Screws

Indications for Use (Describe)

The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.

The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a platescrew system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screws may be used with the Arthrex Low Profile Plates and MaxForce MTP Compression Plates.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and with a plate, the screws may be used with the Arthrex Low Profile Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.

Type of Use (Select one or both, as applicable)
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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	July 6, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanRegulatory Affairs Specialist1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex MaxForce MTP Compression Plates and Screws
Common Name	Plate, fixation, boneScrew, fixation, bone
Product Code	HRS; HWC
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories (Primary Classification);21 CFR 888.3040: Smooth or Threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Devices	K130510: Arthrex Compression Plates (Primary Predicate)K111253: Arthrex Distal Extremity Plate SystemK103705: Arthrex Low Profile Screws
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex MaxForce MTP Compression Plates and Screws.
Device Description	The Arthrex MaxForce MTP Compression Plates and Screws consists of a series ofplates and screws of varying lengths and diameters. The plates are contoured tofit the various aspects of the metatarsals including Petite, Standard, Long, X-Longand Revision with 0° and 5° Valgus and Dorsiflex in left and right configurations.The plates are manufactured from titanium alloy conforming to ASTM F136. Theplates are attached to bone with 3.0 mm cortical, 3.0 mm cortical, hybrid and 3.0mm variable locking screws. The screws range from 3.0 mm to 3.5 mm indiameter and from 10 mm to 26 mm in length. The screws are manufacturedfrom titanium alloy conforming to ASTM F136. The plates and screws are soldnon-sterile and single-use.
Indications for Use	The Arthrex MaxForce MTP Compression Plates are intended to be used forinternal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used asstand-alone bone screws, or in a plate-screw system for internal bone fixation forbone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, andwrist. When used with a plate, the screws may be used with the Arthrex LowProfile Plates, Small Fragment Plates and MaxForce MTP Compression Plates.The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be usedas stand-alone bone screws, or in a plate-screw system for internal bone fixationfor bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand,wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femurand fibula. When used with a plate, the screws may be used with the ArthrexLow Profile Plates, Small Fragment Plates, Humeral Fracture Plates, OsteotomyPlates, and MaxForce MTP Compression Plates.

Performance Data	Engineering analysis, Static Four-Point Bend (ASTM F382), Four-Point BendFatigue (ASTM F382), and plate/instrument compression testing were conductedon the subject plates. Pull-out strength testing (ASTM F543), torsional strengthtesting (ASTM F543) and Insertion Torque testing were conducted on the subjectscrews. The testing demonstrates that the Arthrex MaxForce MTP CompressionPlates and Screws performs statistically equivalent to the predicate devicescleared under K130510, K111253 and K103705.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.
TechnologicalComparison	The Arthrex MaxForce MTP Compression Plates and Screws are substantiallyequivalent to the predicate devices in which the basic design features, intendeduse, fundamental scientific technology, indications for use, sterility, packaging,and shelf-life are identical.The Arthrex MaxForce MTP Compression Plates are contoured to fit the variousaspects of the metatarsals including Petite, Standard, Long, X-Long and Revisionwith 0° and 5° Valgus and Dorsiflex in left and right configurations. Thepredicate Arthrex Compression Plates cleared under K130510 arecontoured to fit the various aspects of the foot, ankle, hand and wristincluding Square, Linear, T- configurations. The predicate ArthrexContoured Plates cleared under K111253 are contoured to fit the metatarsalsincluding Petite, Standard, and Long in left and right configurations.The Arthrex MaxForce MTP Compression Plates and Screws are manufacturedfrom titanium; whereas the predicate Arthrex Compression Plates cleared underK130510 are manufactured from stainless steel. However, the titanium alloyused to manufacture the Arthrex MaxForce MTP Compression Plates and Screwsis identical is identical to the titanium alloy cleared for the Arthrex ContouredPlates cleared under K111253.The Arthrex MaxForce MTP Compression Plates and Screws were evaluated forMR Conditional labeling; whereas the predicate devices were not evaluated forMR Conditional labeling.
Conclusion	The Arthrex MaxForce MTP Compression Plates and Screws are substantiallyequivalent to the predicate devices in which the basic design features andintended uses are the same. Any differences between the proposed devices andthe predicate devices are considered minor and do not raise different questionsconcerning safety or effectiveness.
The Arthrex MaxForce MTP Compression Plates and Screws MR compatibilitytesting supports the devices MR Conditional labeling. There is no increased riskfrom this difference in technology.
The submitted mechanical testing data demonstrates that the Static Four-PointBend, Four-Point Bend Fatigue, Compression Force, Compression Distance, Pull-out and Torque strength of the Arthrex MaxForce MTP Compression Plates andScrews is substantially equivalent to that of the predicate devices for the desiredindications.
Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed devices aresubstantially 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.