The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.

Device Description

The TrueLok™ EVO system is a modular circular external fixation system based on Ilizarov fixation apparatus principles. The TrueLok™ consists of external supports (rings and footplates), variable length struts and a variety of connection elements that build the external frame. The TrueLok™ external frame is secured by using the Orthofix predicates pin and wires. The Subject external support components (rings, footplates and struts), are made from AISI 316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxy carbon fiber. Application and removal of the TL-EVO can be performed with Orthofix general orthopedic instrumentation. TrueLokTM EVO fixator components are provided in single-use sterile configuration and they are available as single component packaged in double pouches or in multiple components packaged in double rigid blister.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the TrueLok™ Evo, a bone fixation device. However, it does not contain information about acceptance criteria for a device's performance, a study proving it meets such criteria, or any details related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices, primarily through:

Indications for Use: Comparing the intended use of the TrueLok™ Evo to predicate devices.
Technological Characteristics: Highlighting similarities in materials, design, and general principles of operation.
Performance Analysis (Non-Clinical): Detailing specific non-clinical tests conducted, such as MRI compatibility testing and mechanical testing according to ASTM standards.

Here's why the requested information cannot be extracted from this document:

Acceptance Criteria & Reported Performance: The document states that the performance data supports substantial equivalence and that the device performs "as well as or better than the predicate devices." It also lists the standards used for testing (ASTM F2052, F2213, F2182, F2119 for MRI, and ASTM F1541-17 for mechanical testing). However, it does not quantify specific acceptance criteria (e.g., "displacement must be less than X mm") nor does it report the specific measured performance values (e.g., "displacement was Y mm") that would allow for a direct comparison in a table as requested. The "Effectiveness" mentioned refers to the device's ability to achieve its intended function, not a quantifiable performance metric for an algorithm.
Sample Size & Data Provenance (Test Set): This document does not describe a "test set" in the context of an algorithm or AI. The performance analysis refers to physical testing of the device components.
Number of Experts & Qualifications / Adjudication Method (Test Set): This information is relevant for studies involving human interpretation or ground truth establishment for AI. It is not applicable to the non-clinical mechanical and MRI compatibility testing described here.
MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or AI assistance for human readers as the device is a physical bone fixation system, not an AI diagnostic tool.
Standalone Performance Study: No standalone algorithm performance study is mentioned for the same reason as above.
Type of Ground Truth: The ground truth for the non-clinical tests described would be the physical measurements and observations during those tests, compared against the limits defined by the regulatory standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense used for AI.
Sample Size for Training Set: Not applicable as there is no AI/algorithm being trained.
How Ground Truth for Training Set was Established: Not applicable as there is no AI/algorithm being trained.

In summary, the provided document details a 510(k) submission for a physical medical device (bone fixation system) and its non-clinical testing to demonstrate substantial equivalence, not the performance of an AI or algorithm. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from this text.

Summary

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November 5, 2021

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Orthofix SRL % Cheryl Wagoner Consultant Wagoner Consulting LLG PO Box 15729 Wilmington, North Carolina 28408

Re: K212044

Trade/Device Name: TrueLok™ Evo Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, LXT Dated: September 24, 2021 Received: September 28, 2021

Dear Cheryl Wagoner:

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,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K212044

Device Name TrueLok™ EVO

Indications for Use (Describe)

The TrueLokTM EVO is intended to provide bone fixation.

Type of Use (Select one or both, as applicable)
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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.

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Image /page/3/Picture/1 description: The image shows the logo for Orthofix, a medical device company. Below the logo is the text "510(k) Summary" and the code "(21 CFR 807.92)". The logo consists of the word "ORTHOFIX" in bold, black letters, with a blue, curved shape above it.

Submitter information

Submitter Name	Orthofix Srl
Address	Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380

Contact Person	Gianluca RicadonaSr. Quality & Regulatory Affairs Manager
Address	Via delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719 000
Fax	+ 39 045 6719 380
Email address	GianlucaRicadona@orthofix.it
Date of preparation	September 14, 2021

Trade Name, Common Name, Classification

Trade Name	TrueLok™ EVO
Device	Appliance, Fixation, Nail/Blade/Plate Combination, MultipleComponent
Primary Product code	KTT, LXT
Panel Code	Orthopedic
Class	Class II
Regulation Number	21 CFR 888.3030
Regulation description	Single/multiple component metallic bone fixation appliancesand accessories

Predicate devices and reference devices

Primary Predicate Devices	510(k) Number	Manufacturer
TRUE LOK MONOLATERAL/BILATERAL FIXATOR	K941048	Orthofix S.r.l.
Reference Device
Orthofix TL-HEX True Lok Hexapod System (TL-HEX)	K152171	Orthofix S.r.l.
ORTHOFIX MODULAR SYSTEM	K944092/K955848/K974186	Orthofix S.r.l.
DePuy Synthes MAXFRAME Multi-Axial Correction System	K161417	Synthes USA, LLC

Device description	The TrueLok™ EVO system is a modular circular external fixation
	system based on Ilizarov fixation apparatus principles.
	The TrueLok™ consists of external supports (rings and
	footplates), variable length struts and a variety of connection
	elements that build the external frame.
	The TrueLok™ external frame is secured by using the Orthofix
	predicates pin and wires. The Subject external support
	components (rings, footplates and struts), are made from AISI316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxycarbon fiber.
	Application and removal of the TL-EVO can be performed withOrthofix general orthopedic instrumentation.
	TrueLokTM EVO fixator components are provided in single-usesterile configuration and they are available as single componentpackaged in double pouches or in multiple componentspackaged in double rigid blister.
Indications for use	The TrueLok™ EVO is intended to provide bone fixation.
	The TrueLok ™ EVO is indicated for fractures, pseudarthrosis /non-unions, lengthening, joint arthrodesis and correction of bonyor soft tissue deformities and defects (e.g. bone transport) in longbones and in the foot.
TechnologicalCharacteristics andIntended Use	The Subject device fundamental scientific principles andtechnological characteristic, including: the intended use, materialand general design, are the same as, or similar to, the chosenpredicate devices.
	Summary of the technological characteristics and Intended Use:
	✓ Intended use: identical for bone fixation.
	✓ Indications for Use, Anatomical sites, operating principlesand conditions of use: are substantially equivalent to themore extensive application of indications of the predicates;no new risks associated to the Subject device compared tothose of the Primary predicates and the additional predicatedevice which have same indications for use, anatomical sitesand conditions of use. Verification activities on Subjectdevices demonstrated the same safety and effectivenessperforms equivalent to the predicate devices.
	✓ Geometry and size: similar sizes and geometry of thepredicates external components; similar sizes and geometryof the predicate bone screws.
	✓ Sterilization, same method as the predicates.The technological characteristics of the TrueLok™ EVO aresubstantially equivalent to the predicate devices.
PerformanceAnalysis	Subject device has similar configuration, sizes and design as thepredicate devices.Performance data was provided in support of the substantialequivalence determination for Magnetic Resonance Imaging(MRI) with respect to the reference predicate device.MRI compatibility testing/assessment was conducted as per theFDA's guidance"Establishing Safety and Compatibility of Passive Implants inthe Magnetic Resonance (MR) Environment", December 11,2014 and the standards listed below:1. Magnetically induced displacement force (ASTM F2052)2 Magnetically induced torque (ASTM F2213)
	3. Radiofrequency (RF) induced heating (ASTM F2182)4. MR image artifact (ASTM F2119)In summary, MR safety testing/assessment supports theappropriate MR parameters and symbols found in the subjectdevice labeling.
	Performance mechanical testing on Subject components itemhave been performed according to: ASTM F1541-17 StandardSpecification and Test Methods for External Skeletal FixationDevices.
	Results to support the determination of substantial equivalencefrom testing and engineering assessments on worst cases ofSubject device and corresponding predicate devices and othersimilar devices, confirm that Subject device, as safe, aseffective, and performs as well as or better than the predicatedevices.Any potential hazards have been evaluated and controlledthrough Risk Management activities, and any relevantinformation, have been addressed in the labelling, after allcontrol measures have been implemented.The review of the current clinical literature on the predicates andon other similar devices have been conducted to support theclinical indications of TrueLok™ EVO without requiring furtherclinical data.
Conclusion	Based upon equivalences in: intended use, site of application,conditions of use, operating principles, and the non-clinicalperformance data, the TrueLok™ EVO has been shown to besafe and effective, and to perform equivalently as compared tothe legally marketed predicate devices.Therefore, the Subject device is substantially equivalent to thelegally 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.