The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (3.5 mm 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, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

Device Description

The Arthrex VAL KreuLock™ Compression Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and the standard versions range in lengths from 10 mm to 90 mm while the reinforced versions range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.
The Arthrex VAL Screws are fracture fixation devices comprised of titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping, solid, fully threaded, variable angle locking screws that are offered in standard and reinforced configurations. They are offered with a 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The reinforced configurations have a larger minor diameter with the same major diameter as the standard configurations.

AI/ML Overview

The provided text describes the 510(k) summary for the Arthrex VAL and VAL KreuLock™ Compression Screw System. This document outlines the device's technical specifications, indications for use, and a comparison to predicate devices, primarily focusing on demonstrating substantial equivalence through various mechanical and material tests.

However, there is no information within this document that describes a study involving an "AI device" or "algorithm." The document pertains to a medical device for bone fixation (screws), not a diagnostic or AI-powered imaging/analysis tool. Therefore, it does not contain the details typically sought when asking about acceptance criteria and study designs for AI/algorithmic devices, such as:

A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, etc.)
Sample sizes for test sets of AI data
Data provenance for AI training/test sets
Number of experts for ground truth establishment for AI
Adjudication methods for AI ground truth
Multi-reader multi-case (MRMC) studies for AI assistance
Standalone performance of an AI algorithm
Type of ground truth used for AI models
Sample size and ground truth establishment for AI training sets

To directly answer your request based on the provided text, the answer is that the given document does not contain the information you are asking for, as it is not about an AI/algorithmic device.

The "Performance Data" section of the document describes the following types of tests for the mechanical bone screws:

Mechanical Testing:
- Pullout testing
- Cantilever testing
- Pushout testing
- Head locking testing
- Compression testing
- Torque testing
- Axial pullout analysis
- Torsional strength testing
- Driving torque testing
- These tests were conducted in accordance with ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate that the changes do not affect performance and that the proposed devices are substantially equivalent to the primary predicate device.
MRI Compatibility Testing:
- 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 (Measurement of Magnetically Induced Displacement Force)
  - ASTM F2119 (Evaluation of MR Image Artifacts from Passive Implants)
  - ASTM F2182 (Measurement of Radio Frequency Induced Heating near Passive Implants)
  - ASTM F2213 (Measurement of Magnetically Induced Torque on Medical Devices)

The acceptance criteria for these mechanical tests would typically be defined by the relevant ASTM standards and comparative data against the predicate device to demonstrate equivalent or superior performance in the specified mechanical properties. The study "proves" the device meets these criteria by showing that the results of these tests fall within acceptable ranges as compared to the predicate device.

To reiterate, if you're looking for information specific to AI/algorithmic device acceptance criteria and study designs, this document does not provide it because the device described is a physical bone screw system.

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). 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 31, 2024

Arthrex, Inc. Konrad Wolfmeyer Regulatory Affairs Senior Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K241592

Trade/Device Name: Arthrex VAL and VAL KreuLock™ Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HRS Dated: May 31, 2024 Received: June 3, 2024

Dear Konrad Wolfmeyer:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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,

Christopher Ferreira -S

Christopher Ferreria, M.S. 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

Submission Number (if known)

K241592

Device Name

Arthrex VAL and VAL KreuLock™ Compression Screw System

Indications for Use (Describe)

The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, pelvis, acetabulum, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (3.5 mm 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, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

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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K241592 510(k) Summary

Date Prepared	August 29, 2024
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Konrad WolfmeyerTitle: Senior Regulatory Affairs Specialist Phone: 1-317-607-4265Email: Konrad.Wolfmeyer@arthrex.com
Trade Name	Arthrex VAL and VAL KreuLock™ Compression ScrewSystem
Common Name	Arthrex VAL and VAL KreuLock™ Compression ScrewSystem
Product Code	HWC
Classification Name	21 CFR 888.3040 Screw, Fixation, Bone
Regulatory Class	II
Primary Predicate Device	K201132 Arthrex Compression Screws
Additional Predicate Device(s)	K103705 Arthrex Low Profile ScrewsK143614 Arthrex Low Profile VAL Screw
Reference Device	K082516 Smith & Nephew PERI-LOC Hexalobular BoneScrews
Purpose of Submission	This Traditional 510(k) premarket notification is submitted toobtain clearance for the Arthrex VAL andVAL KreuLock™ Compression Screw System
Device Description	The Arthrex VAL KreuLock™ Compression Screws are fracturefixation devices comprised of titanium (Titanium Ti-6AL-4Vper ASTM F1472) self-tapping, solid, fully threaded, variableangle locking screws that are offered in standard andreinforced configurations. They are offered with a 3.5 mmdiameter and the standard versions range in lengths from 10mm to 90 mm while the reinforced versions range in lengthsfrom 10 mm to 110 mm. The reinforced configurations have alarger minor diameter with the same major diameter as thestandard configurations.The Arthrex VAL Screws are fracture fixation devices comprisedof titanium (Titanium Ti-6AL-4V per ASTM F1472) self-tapping,solid, fully threaded, variable angle locking screws that areoffered in standard and reinforced configurations. They areoffered with a 3.5mm diameter and range in lengths from 10 mm to 110mm. The reinforced configurations have a larger minor
	diameter with the same major diameter as the standardconfigurations.
Indications for Use	The Arthrex VAL KreuLock™ Compression Screws (3.5mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bonefractures, fusions, Osteotomies and non-unions in theankle, foot, hand, wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneus, pelvis,acetabulum, metacarpals, metatarsals, femur and fibula.When used with a plate, the screws may be used with theArthrex Low Profile Plate, Small Fragment Plates,Fracture Plates, Distal Extremity Plates, Distal RadiusPlates, Humeral Fracture Plates, Osteotomy Plates, andAnkle Fusion Plates.
	The Arthrex VAL Screws (3.5 mm and larger, solid) areintended to be used as stand-alone bone screws, or in aplate-screw system for internal bone fixation for bonefractures, fusions, osteotomies and non-unions in theankle, foot, hand, wrist, clavicle, scapula, olecranon,humerus, radius, ulna, tibia, calcaneus, pelvis,acetabulum, metacarpals, metatarsals, femur and fibula.When used with a plate, the screws may be used with theArthrex Low Profile Plate, Small Fragment Plates,Fracture Plates, Distal Extremity Plates, Distal RadiusPlates, Humeral Fracture Plates, Osteotomy Plates, andAnkle Fusion Plates.
Performance Data	Arthrex conducted pullout testing, cantilever testing,pushout testing, head locking testing, compressiontesting, torque testing, axial pullout analysis, torsionalstrength testing, and driving torque testing wasconducted in accordance with ASTM F543 StandardSpecification and Test Methods for Metallic MedicalBone Screws on the proposed Arthrex VAL and VALKreuLock™ Compression Screw Systems to demonstratethat the change do not affect performance and theproposed devices are substantially equivalent to theprimary predicate device.MRI force, torque, and image artifact testing wereconducted in accordance with FDA guidance Testingand Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 Standard
	Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the Magnetic
	Resonance Environment, ASTM F2119 Standard TestMethod for Evaluation of MR Image Artifacts fromPassive Implants, ASTM F2182 Standard Test Methodfor Measurement of Measurement of Radio FrequencyInduced Heating Near Passive Implants During MagneticResonance Imaging and ASTM F2213 Standard TestMethod for Measurement of Magnetically InducedTorque on Medical Devices in the Magnetic ResonanceEnvironment.
Technological Comparison	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem is substantially equivalent to the predicatedevices cleared under K201132 in which the basic designfeatures, fundamental scientific technology, materials,shelf-life (non-sterile only), and sterility (non-sterileonly) are identical.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem is manufactured from titanium, which is thesame material as the primary predicate device clearedunder K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices have the same sterility, non-sterile, asthe primary predicate cleared under K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices have the same packaging as the primarypredicate cleared under K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices have the same shelf-life, unlimited, asthe primary predicate cleared under K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices have the same fundamental scientifictechnology as the primary predicate cleared underK201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices were evaluated for MRI Conditionallabeling, which is the same as the primary predicatecleared under K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices have an indications for use that differsfrom the primary predicate cleared under K201132.
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem devices are offered in longer lengths than theprimary predicate cleared under K201132.	K241592 - Page 3 of 4
	The Arthrex VAL and VAL KreuLock™ Compression ScrewSystem is substantially equivalent to the predicate devicescleared under K201132. Any differences between theArthrex VAL and VAL KreuLock™ Compression ScrewSystem and the predicate device cleared under K201132are considered minor and do not raise different questionsof safety or effectiveness.
Conclusion	Based on the intended use, fundamental scientifictechnology, and the data provided in this thisTraditional 510(k), Arthrex has determined that theArthrex VAL and VAL KreuLock™ Compression ScrewSystem is substantially equivalent to the predicatedevices. Any differences between the proposed andpredicate devices are considered minor and do not raisedifferent questions concerning safety and effectiveness.

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.