The OrthoPediatrics Orthex External Fixation System is an external fixator which includes typical components such as rings, partial rings, footplates, monolateral rails, and numerous hardware necessary for the construction of a frame to which tensioned wires and half pins are attached to the bone and to the frame itself. The system has an optional software to assist the user in adjusting the hexapod.

The components included in external fixation systems are made from various types of metal and plastic materials. Half pins and wires are manufactured from implant grade materials and are non-pyrogenic. External fixation components and implants are for single use only and not designed or sold for any use except as indicated.

The web-based Orthex Point and Click (P&C) Software aids the surgeon in the use of the Orthex External Fixation System. The software is optional to use. The Orthex Point and Click (P&C) Software does not control any hardware (such as rings, struts, wires, half pins) directly. The Point and Click (P&C) Software is only compatible with the Orthex External Fixation System. It can be accessed at www.orthex.net. The Pre-Operative planning function of the software aids the surgeon in pre-operative deformity analysis which includes determining where an osteotomy will be made, visualizing corrections, and planning for hexapod construction by positioning rings and calculating the initial strut lengths in preparation for frame application. The Post-Operative planning function of the software aids the surgeon in producing a strut length schedule to achieve the desired correction. The patient or caregiver manually adjusts the struts according to the strut length schedule.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the OrthoPediatrics Orthex External Fixation System. It grants clearance for the device based on its substantial equivalence to a predicate device.

The prompt requires information about acceptance criteria and a study that proves the device meets them, specifically for a software component ("P&C Software"). However, this document primarily discusses the hardware aspects and the software's role as an optional component. It states that the key updates to the software relate to adding a pre-operative planning function, changing schedule output formatting, and improving X-ray page functionality. The most significant software-related change mentioned is the re-addition of the "Rear and Mid-foot Foot Arthrodesis" indication to the software, as the software now includes the necessary modules and icons.

Crucially, this document does not describe any specific clinical study demonstrating accuracy or clinical effectiveness for the software. Instead, it relies on:

Substantial Equivalence: The primary argument is that the device (hardware and updated software) is substantially equivalent to a previously cleared predicate device.
Verification and Validation (V&V) Testing: It broadly states, "The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use."

Given this, I cannot provide detailed answers to many of the sub-questions as they pertain to clinical or performance studies that are not described in this document. The V&V testing mentioned is typically internal engineering testing, not a comparative effectiveness study with human readers or standalone performance data in the way implied by the questions.

Therefore, the following table and explanations reflect what can be inferred or directly stated from the provided text, and where information is not present.

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria	Reported Device Performance (Summary from Document)
Software Functional Performance (Implicitly, that the software performs its intended functions correctly)	"The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use." This includes: - Pre-operative planning function - Changing schedule outputs formatting - Improved X-Ray pages' functionality - Inclusion of foot and ankle modules/icons to support "Rear and Mid-foot Foot Arthrodesis" indication.
Safety (Hardware, MR Environment) (Explicitly for hardware)	"The Orthex External Fixation System is MR unsafe" due to ferromagnetic materials.
Substantial Equivalence (Overall regulatory criterion)	"The Orthex External Fixation System is as safe and effective as the predicate device."

Study Details (As much as can be gleaned from the document):

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "verification and validation testing" but does not detail a test set in terms of patient data or clinical cases. This testing is likely internal engineering and functional testing of the software itself and its algorithms, rather than a clinical study with a patient data test set.
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):
- Not specified. Ground truth establishment, if any, for software function would likely be based on engineering specifications or perhaps orthopedic surgical principles, not necessarily expert adjudication of clinical cases as would be done for an AI diagnostic device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. This pertains to clinical studies often involving AI, which is not detailed here.
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:
- No such study is described. The document indicates the software "aids the surgeon" and "is optional to use." It explicitly states, "The P&C Software is intended to be used as a component of multilateral external fixations listed above," implying an assistive role. However, no MRMC study or data on human reader improvement with or without AI assistance is provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone performance study is explicitly described in terms of clinical accuracy. The "verification and validation testing" would represent internal standalone performance assessments against design requirements, but not typically a stated accuracy metric like AUC or sensitivity/specificity for a diagnostic AI. The software's role is assistive, not a standalone diagnostic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for a clinical ground truth. For the software's functionality, ground truth would be based on engineering specifications, mathematical models for hexapod adjustments, and established orthopedic principles for deformity correction and planning.
The sample size for the training set:
- Not applicable / Not specified. This device's software is described as tool-based (calculating strut lengths, pre-operative planning) rather than a machine learning model that requires a "training set" in the conventional sense of deep learning or AI. It seems to be based on deterministic algorithms.
How the ground truth for the training set was established:
- Not applicable / Not specified. As it does not appear to be an AI/ML model with a "training set," this question is not relevant based on the information provided. Its "ground truth" would be the mathematical correctness of its calculations and the accurate representation of orthopedic planning principles.

Summary

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February 10, 2023

OrthoPediatrics Corp. Yan Li Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582

Re: K223786

Trade/Device Name: Orthex External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: December 16, 2022 Received: December 19, 2022

Dear Yan Li:

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

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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 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,

Ting Song -S

Ting Song, Ph.D. 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

510(k) Number (if known) K223786

Device Name Orthex External Fixation System

Indications for Use (Describe)

The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

· Stabilization of Fractures & Osteotomy
· Rear and Mid-foot Foot Foot Arthrodesis
· Adult and Pediatric Leg Lengthening
· Correction of Bone Deformity in Upper & Lower Extremities

The P&C Software is intended to be used as a component of multilateral external fixations listed above.

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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Image /page/3/Picture/1 description: The image shows the logo for OrthoPediatrics. The logo features a cartoon drawing of a child with a smiling face and one arm raised. The company name is written in a playful font, with the "Ortho" in blue and the "Pediatrics" in red.

K223786 Page 1 of 4

510(k) Summary

I. Submitter

Submission:	Traditional 510(k) Premarket Notification
Applicant:	OrthoPediatrics Corp.
Applicant Address:	2850 Frontier Drive, Warsaw, IN 46582
Establishment Registration Number:	3006460162
Contact:	Yan Li
Contact Phone:	(574) 267-0864
Date Prepared:	February 1, 2023

II. Device

Device Trade Name:	Orthex External Fixation System
Regulation Number:	21 CFR 888.3030
Regulation Name:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories
Device Classification:	II
Classification Panel:	Orthopedic
Classification Product Code:	KTT, OSN

III. Predicate Device and Reference Device

Substantial equivalence is claimed to the following predicate device:

. Primary Predicate: X-Fix Line Additions (K151881, OrthoPediatrics Corp.)
This submission includes the following reference device:
Reference Predicate: Orthofix Truelok Hexapod System (TL-HEX) V2.0 (K170650, ● Orthofix srl)

Note:

1. In 2015, Vilex in Tennessee, Inc. submitted K151881 for "X-Fix Line Additions" and received the clearance of additional external fixation components and the Point and Click (P&C) Software for the Orthex External Fixation System.

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Image /page/4/Picture/2 description: The image is a logo for OrthoPediatrics. The logo features a cartoon face with a smile, with the word "Ortho" written in blue next to it. The word "Pediatrics" is written in red to the right of "Ortho". The logo also includes a green cartoon figure with arms that appear to be hugging the word "Ortho".

1. On June 4, 2019, OrthoPediatrics Corp. ("OrthoPediatrics") purchased all of the issued and outstanding shares of stock of Vilex in Tennessee, Inc. ("Vilex"), and Vilex became a wholly owned subsidiary of OrthoPediatrics Corp. According to the purchase agreement, OrthoPediatrics becomes the manufacturer of the Orthex External Fixation System and the owners of the predicate 510(k) for the system.

IV. Device Description

V. Indications for Use

The OrthoPediatrics Orthex External Fixation System is intended for external fixation with the following indications:

Stabilization of Fractures & Osteotomy ●
Rear and Mid-foot Foot Arthrodesis ●
Adult and Pediatric Leg Lengthening
Correction of Bone Deformity in Upper & Lower Extremities ●

The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.

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Image /page/5/Picture/2 description: The image is a logo for a company called "OrthoPediatrics". The logo features a cartoon drawing of a smiling face with a body made of a banana. The word "Ortho" is written in blue and is connected to the cartoon drawing. The word "Pediatrics" is written in red and is to the right of the word "Ortho".

When the hardware of the Orthex External Fixation System was cleared under K052196, K 132820, K 163487, the indication of "Rear and Mid-foot Foot Arthrodesis" was cleared, however this indication was removed when the software v1.1 was initially cleared under K151881, as the software at that time did not yet include the foot and ankle modules and icons to support this indication. The subject software now includes foot and ankle module and icons to support this indication. Since the foot and ankle anatomical modules exists in the subject software, the indication of "Rear and Mid-foot Foot Arthrodesis" is added back to the full set of indications for the Orthex External Fixation Svstem. Adding back this indication provides consistency so that the hardware and software of the Orthex External Fixation System have identical intended use and indications for use.

VI. Comparison of Technological Characteristics

The Orthex External Fixation System and the predicate devices share the same intended use, principle of operation, anatomical sites, and many other fundamental technological characteristics.

Updates made to the software since its initial clearance via K151881 include adding the preoperative planning function, changing the schedule outputs formatting and improving the X-Ray pages' functionality. The safety and effectiveness of all the updates made to the software since its initial clearance have been successfully verified and validated. The software documentation including the verification and validation testing support that the subject software has met applicable design requirements established based on their intended use. Therefore, the updates made to the predicate software cleared via K151881 do not raise new questions of safety or effectiveness.

An evaluation has been done on the hardware of the Orthex External Fixation System to evaluate safety in the MR environment. A magnet was passed over the device ensuring contact is made between the magnet and device. Multiple hardware components exhibit magnetic properties and are supported by the magnet under their own weight. The subject device's labeling was revised to indicate "The Orthex External Fixation System is MR unsafe."

VII. Performance Data

There is no new hardware to be added to the Orthex External Fixation System via this submission. All class II hardware in the Orthex External Fixation System has been cleared in previous 510(k)s. Thus, bench testing or biocompatibility testing on the hardware is not necessary to support the change of MRI safety labeling to "MR unsafe" or to support the safety and effectiveness of the updated software. The Orthex External Fixation System have been evaluated for use in an MR Environment. There are components in the system that contain ferromagnetic materials and thus it is determined that Orthex External Fixation System is MR Unsafe. Successful software verification and validation testing have been conducted to support the safety and effectiveness of the updates made the software since its initial clearance via K151881.

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Image /page/6/Picture/1 description: The image is a logo for OrthoPediatrics. The logo features a cartoon drawing of a child's face with a smile. The word "Ortho" is written in blue, and the word "Pediatrics" is written in red. The logo is designed to be playful and inviting, and it conveys the message that OrthoPediatrics is a company that cares about children.

K223786 Page 4 of 4

VIII. Conclusion

The information provided above supports that the Orthex External Fixation System is as safe and effective as the predicate device. Information and data provided within the submission support the differences between the subject and predicate devices. Therefore, it is concluded that the Orthex External Fixation System is substantially equivalent to the 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.