The Construx External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.

Device Description

The Construx External Fixation System consists of a central body, and several other components that can be used to create an external fixation frame. These components include:

Male Stem Assembly
Aluminum Ankle Assembly
Carbon Ankle Assembly
Carbon Straight Clamp Assembly
Aluminum Male Straight Clamp
Aluminum Female Straight Clamp
Aluminum T-clamp
Aluminum Angular Hinge Clamp
Aluminum Ring Adapter
These components can be used with the DFS Bone Screws, and other components of the DFS Standard Fixator, DFS Ring and Vision External Fixation Systems.

AI/ML Overview

The presented document is a 510(k) Summary for the Construx External Fixation System, which is a medical device for bone fixation. The document details the device description, indications for use, and a summary of performance data. However, the available text does not contain the specific acceptance criteria or an in-depth study report that would allow for a detailed answer to all parts of your request regarding AI/algorithm performance.

Here's what can be extracted and inferred from the provided text regarding the device's performance assessment, along with the information that is not present:

Acceptance Criteria and Study for Construx External Fixation System (Non-AI Device)

The Construx External Fixation System is a mechanical device, not an AI/algorithm. Therefore, the questions related to AI performance, such as human reader improvement with AI, standalone algorithm performance, training data, and expert ground truth for AI models, are not applicable to this document. The "Performance Data" section solely discusses mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Established by Predicate Devices)	Reported Device Performance
Met for Static Testing (Assumed, based on text)	New Construx components met the established acceptance criteria set by the predicate devices.
Met for Fatigue Testing (Assumed, based on text)	New Construx components met the established acceptance criteria set by the predicate devices.

Note: The specific numerical values or qualitative descriptions of the acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the exact performance results are not detailed in this summary document. The document only states that the new components met the established criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Mechanical testing was performed on the Construx External Fixation System. Static and fatigue testing was performed on the new Construx components assembled as external fixation constructs."

Sample Size for Test Set: Not specified. The number of constructs or individual components tested is not provided.
Data Provenance: The nature of mechanical testing generally means the "data" is generated in a lab setting, not typically originating from a country or being retrospective/prospective in the way clinical data would be.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This question is not applicable to mechanical testing of a physical device. Ground truth for mechanical testing is based on engineering specifications and physical measurements, rather than expert clinical consensus.

4. Adjudication Method for the Test Set

This question is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation or clinical data, not for objective mechanical performance.

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

This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI or imaging diagnostic tool.

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

This question is not applicable. The Construx External Fixation System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Engineering specifications and established performance benchmarks derived from the predicate devices. For mechanical testing, this typically involves stress, strain, displacement, and cycle count measurements against pre-defined limits.

8. The Sample Size for the Training Set

This question is not applicable. Mechanical testing does not typically involve a "training set" in the context of machine learning or algorithms. The "training" for such a device would be the design and manufacturing process, optimized based on engineering principles and prior device data.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reasons as #8. The "ground truth" for the design and manufacturing would be based on biomechanical principles, material science, and regulatory requirements, informed by the performance of predicate devices.

Summary of Missing Information:

The provided 510(k) summary is a high-level overview. For a comprehensive understanding of the acceptance criteria and study, one would typically need access to the full test report, which would detail:

Specific test methods (e.g., ASTM standards referenced).
Exact load conditions, displacement limits, and cycle counts for static and fatigue tests.
The number of samples tested for each configuration.
The actual measured performance values compared against the criteria.
Detailed information about the predicate device's performance data that established these criteria.

Summary

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KIII376 (pg 1/2)

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AUG - 3 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	May 12, 2011
Applicant/Sponsor:	EBI, LLC100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Margaret F. CrowePhone: 973-299-9300 x2260Fax: 973-257-0232
Trade name:	Construx External Fixation System
Common Name:	External fixation system
Classification Name(Product Code):	KTT/Single/multiple component metallic bone fixationappliances and accessories
Device Panel - Regulation No .:	Orthopedic - 21 CFR 888.3030

The purpose of this submission is to clear for marketing components of the Construx External Fixation System.

Device Description

The Construx External Fixation System consists of a central body, and several other components that can be used to create an external fixation frame. These components include:

Male Stem Assembly
. Aluminum Ankle Assembly
Carbon Ankle Assembly .
. Carbon Straight Clamp Assembly
Aluminum Male Straight Clamp .
Aluminum Female Straight Clamp
Aluminum T-clamp .
. Aluminum Angular Hinge Clamp
Aluminum Ring Adapter .

These components can be used with the DFS Bone Screws, and other components of the DFS Standard Fixator, DFS Ring and Vision External Fixation Systems.

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Indications for Use

Summarv of Technologies

The technological characteristics (material, design and sizing) of the Construx External Fixation System is the same as, or similar to, the predicate devices. Examples of predicate devices include:

(K953406)

. Construx External Fixation System (K953406/K021695/K023324)
DFS Aluminum Ankle Assembly .
- DFS Carbon Ankle Assembly (K031919)
. DFS Carbon Fixator Straight Clamp (K040935)
. DFS Left and Right Telescoping Arms (K953406)
DFS Angular Hinge Clamp (K953406) �
DFS Ring to Fixator Connector (K953406) .

All of the named predicate systems were subsequently cleared for use in children in K081244.

Performance Data

Mechanical testing was performed on the Construx External Fixation System. Static and fatigue testing was performed on the new Construx components assembled as external fixation constructs. The new components met the established acceptance criteria set by the predicate devices.

Substantial Equivalence

The Construx External Fixation System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. The predicates listed above are distributed for similar indications, and have similar design features.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

EBI, LLC % Margaret F. Crowe 100 Internace Pkwy. Parsippany, NJ 07054

AUG - 3 2011

Re: K111376

Trade/Device Name: Construx External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: May 13, 2011 Received: May 16, 2011

Dear Ms. Crowe:

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. 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

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Page - 2 - Ms. Margaret F. Crowe

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KU1376 (pg 1/1)

Device Name: Construx External Fixation System

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Temperature

Jor M. Meckerson

(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices

510(k) Number K111376

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.