The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:

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

Device Description

The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities.

The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.

AI/ML Overview

The provided text describes the Correx Software (K212552), intended for use with the Vilex External Fixation System. However, it does not contain specific acceptance criteria or reported device performance metrics in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance studies with acceptance criteria and statistical results.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

The 510(k) summary states:

"Software verification and validation testing was undertaken to ensure that the product requirements and specifications were met."

This indicates that internal testing was performed, but the details of this testing (acceptance criteria, specific performance metrics, study design, sample sizes, etc.) are not provided in this public document.

Missing Information:

A table of acceptance criteria and the reported device performance: This is the primary missing piece. The document merely confirms that "Software verification and validation testing was undertaken."
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The focus is on the software's ability to compute strut lengths, not on human reader performance with or without AI assistance.
If a standalone study was done: The description implies standalone testing as it focuses on software verification and validation, but specific study details are absent.
The type of ground truth used: Not specified.
The sample size for the training set: Not specified, as this appears to be a software tool for calculation/visualization, not an AI/ML model that typically requires a large training set in the conventional sense.
How the ground truth for the training set was established: Not specified.

What can be inferred from the document:

Device Function: The Correx Software is an "optional-use computational environment" that helps determine the orientation of bone segments and external fixator elements, and computes strut lengths. It takes "Surgeon Inputs based on X-Ray positioning" as input and outputs a "Daily schedule of strut lengths."
Intended Use: As a component of a multilateral external fixation system for specific orthopedic indications (fractures, osteotomy, arthrodesis, leg lengthening, deformity correction).
Comparison to Predicate: The document claims "The subject and predicate device share the same intended use and technological characteristics." This implies that the performance expectations would be similar to the predicate (X-Fix Line Additions, K151881), which is also software for diagnosis/treatment in external fixation.

Conclusion based on the provided text:

The provided 510(k) summary for Correx Software (K212552) indicates that verification and validation testing was performed to meet product requirements. However, it does not include the specific details of acceptance criteria, reported performance, study designs, sample sizes, or ground truth establishment that would typically be found in a detailed study report. The document's purpose is a regulatory submission for substantial equivalence, not a publication of a detailed performance study.

Summary

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October 12, 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 image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vilex LLC % Roshana Ahmed Sr. Regulatory Affairs Specialist TELOS Partners LLC 571 Christina Lake Drive Lakeland, Florida 33813

Re: K212552

Trade/Device Name: Correx Software Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW, OSN Dated: August 13, 2021 Received: August 13, 2021

Dear Roshana Ahmed:

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

510(k) Number (if known)

K212552

Device Name

Correx Software

Indications for Use (Describe)

The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:

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

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)

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510(k) Summary

I. Submitter

Vilex, LLC 111 Moffitt Street McMinnville, TN 37110

Contact Person: Brock Johnson, Vice President Phone: (435)-659-1880 Date Prepared: October 12, 2021

II. Device

Device Proprietary Name:	Correx Software
Common or Usual Name:	Software for Diagnosis/TreatmentExternal Fixation System
Classification Name:	Single/Multiple Component Metallic Bone Fixation Appliancesand Accessories
Regulation Number:	21 CFR 888.3030
Product Code:	KTT/JDW/OSN
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

X-Fix Line Additions, K151881, Vilex in Tennessee, Incorporated ●

IV. Device Description

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rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.

V. Indications for Use

The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below:

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

VI. Comparison of Technological Characteristics

The subject and predicate device share the same intended use and technological characteristics.

A comparison of products technological characteristics is provided in the table below.

	Correx Software	P&C Software
		K151881
Intended User	Healthcare Professional	Same
Software Use	Optional	Same
Principles ofOperation	The Software can be used to visualize theposition of a moving bone segment and tocompute the strut lengths necessary toimplement any desired translation orrotation.	Same
Inputs	Surgeon Inputs based on X-Raypositioning	Same
ImageRequirements	A/P and M/L radiographs after ExternalFrame attached to bone segments	Same
System Fields(Data Inputs)	Ring Size, Struts, Preference Side,Deformity, Correction, Bone Alignment,Separation Rate	Same
Output	Daily schedule of strut lengths necessaryto adjust the frame so that the bonesegments are aligned as desired andtranslated to the desired position within aminimum number of days	Same

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VII. Performance Data

Software verification and validation testing was undertaken to ensure that the product requirements and specifications were met.

VIII. Conclusion

Based on the information provided above and within this submission, the Correx Software 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.

Indications for Use

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510(k) Summary

I. Submitter

II. Device

III. Predicate Device

IV. Device Description

V. Indications for Use

VI. Comparison of Technological Characteristics

VII. Performance Data

VIII. Conclusion

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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