The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAME™ External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.

AI/ML Overview

The provided documentation describes a 510(k) submission for the SIDEKICK® EZ FRAME™ External Fixation System, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical studies to prove effectiveness against predefined acceptance criteria for a novel device.

Therefore, many of the requested details regarding acceptance criteria, extensive study design, ground truth, and reader studies are not applicable or explicitly stated in this type of submission for this device.

Here's an analysis based on the information provided:

Analysis of Acceptance Criteria and Study for SIDEKICK® EZ FRAME™ External Fixation System

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for an external fixation system, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device through mechanical and design comparisons, rather than clinical performance metrics like sensitivity, specificity, or accuracy.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence: Does the new device perform mechanically at least as well as the predicate device, without representing a new worst-case scenario?	The submission states: "Through mechanical component analysis and comparison the subject system does not represent a new worst-case." This indicates that mechanical performance was evaluated against the predicate and deemed equivalent or better.
Design and Materials Equivalence: Are the design characteristics, materials, and method of operation similar enough to the predicate device?	The submission states: "The subject device operates in the same method as the predicate" and "The design characteristics of the subject system do not raise new types of questions of safety or effectiveness." This implies that the design and method of operation are demonstrably similar to the predicate.
Intended Use Equivalence: Does the new device have the same or similar intended uses as the predicate device?	The intended uses listed for the SIDEKICK® EZ FRAME™ (Triple arthrodesis, Isolated rearfoot arthrodesis, Midfoot arthrodesis, Comminuted trauma, Diabetic Charcot reconstruction, Most foot pathology not requiring fixation above the ankle) are implicitly considered equivalent or acceptable in scope compared to the predicate device, as FDA cleared the device for these indications.
Safety and Effectiveness: Does the device perform at least as well as the predicate systems without raising new questions of safety or effectiveness?	The submission concludes: "From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems." The FDA's clearance letter confirms this conclusion regarding substantial equivalence.

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

Not Applicable. This submission relies on substantial equivalence through mechanical and design comparison, not a "test set" of patient data in the typical sense of a clinical trial for a novel diagnostic or therapeutic device. The "test set" would primarily consist of the device components themselves undergoing mechanical testing. The document does not specify a sample size for such mechanical tests, nor does it detail data provenance in terms of patient population or origin.

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

Not Applicable. Ground truth, in the context of clinical studies involving expert interpretation, is not relevant here. The evaluation is against the performance and characteristics of a predicate device, which itself has established safety and effectiveness.

4. Adjudication Method for the Test Set:

Not Applicable. As there is no "test set" involving human interpretation or clinical endpoints requiring adjudication, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

No. This device is an external fixation system (a hardware medical device), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant and was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used:

Not Applicable / Predicate Device Performance. For this type of submission, the "ground truth" is effectively the established safety and effectiveness profile, mechanical performance, and design characteristics of the legally marketed predicate device. The new device's performance is gauged against this established benchmark.

8. The Sample Size for the Training Set:

Not Applicable. As this is not an AI/ML device, there is no "training set" of data as understood in that context. The device's design and manufacturing rely on established engineering principles and materials science, not machine learning algorithms trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. Since there is no training set, there is no ground truth to establish for it.

Summary

{0}------------------------------------------------

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

APR 0 5 2013

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SIDEKICK® EZ FRAME™ External Fixation System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.5677 Airline RoadArlington, TN 38002
Date:	January 4, 2013
Contact Person:	Ryan BormannRegulatory Affairs Specialist II(901) 867-4409
(a)(2). Proprietary Name:	SIDEKICK® EZ FRAME™ External FixationSystem
Common Name:	External Fixation Device
Classification Name and Reference:	21 CFR 888.3030 - Class II
Device Product Code, Device Panel:	KTT, Appliance, Fixation, Nail/Blade/PlateCombination, Multiple Component
(a)(3). Predicate Device:	K043289 E-Z FRAME EXTERNAL SURGICALSUPPORT BOOT

(a)(4). Device Description

(a)(5). INTENDED USE

· Triple arthrodesis
· Isolated rearfoot arthrodesis
· Midfoot arthrodesis
· Comminuted trauma
· Diabetic Charcot reconstruction
· Most foot pathology not requiring fixation above the ankle

{1}------------------------------------------------

(a)(6). Technological Characteristics Comparison

The subject device operates in the same method as the predicate.

(b)(1). Substantial Equivalence – Non-Clinical Evidence ·

Through mechanical component analysis and comparison the subject system does not represent a new worst-case.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter dated: April 5, 2013

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

Wright Medical Technology, Inc. % Mr. Ryan Bormann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K130044

Trade/Device Name: SIDEKICK® EZ FRAME™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT, HTY, JEC Dated: January 4, 2013 Received: January 8, 2013

Dear Mr. Bormann:

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 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 (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Ryan Bormann

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N.Melkerson -S

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K130044

Device Name: SIDEKICK® EZ FRAME™ External Fixation System

Indications For Use:

Triple arthrodesis .
lsolated rearfoot arthrodesis .
Midfoot arthrodesis
. Comminuted trauma
. Diabetic Charcot reconstruction
Most foot pathology not requiring fixation above the ankle .

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Casey LTHanley Division Devices

Concurrence of CDRH, Office of Device Evaluation (ODE) 1 of 1

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.