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 FRAMETM 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

This document is a 510(k) premarket notification for a medical device called the SIDEKICK® EZ FRAME™ External Fixation System. It asserts substantial equivalence to a predicate device, rather than providing a study demonstrating its own performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies for the device in question cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance in terms of metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Not applicable. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance criteria for the new device.	Not applicable. Device performance metrics against specific acceptance criteria are not presented.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission states "Substantial Equivalence - Non-Clinical Evidence" and "Through technological comparison, the subject system does not represent a new worst-case." and "Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical or performance test set was used for the sidekick EZ FRAME in this submission. The evaluation is based on technological comparison and material/design similarities to a predicate device.

3. 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 applicable. No test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set was used.

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

Not applicable. This device is a mechanical external fixation system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical external fixation system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. Ground truth is not relevant in a substantial equivalence filing for a mechanical device based on technological comparison.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or ground truth for it.

Summary based on the document:

The document asserts that the SIDEKICK® EZ FRAME™ External Fixation System is substantially equivalent to a legally marketed predicate device (K130044: SIDEKICK® EZ FRAME™ External Fixation System) based on technological characteristics comparison. The submission explicitly states:

Non-Clinical Evidence: "Through technological comparison, the subject system does not represent a new worst-case."
Clinical Evidence: "N/A" (Not Applicable)
Conclusion: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device."

This means that the "study" proving the device meets criteria is primarily a comparative analysis of its design, materials, and intended use against an already approved predicate device, demonstrating that it does not introduce new safety or effectiveness concerns. No new performance studies with acceptance criteria, test sets, or ground truth establishment were conducted or reported for this 510(k) submission.

Summary

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

January 8, 2015

Wright Medical Technology, Incorporated Ms. Leslie Fitch Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K143220

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: Class II Product Code: KTT Dated: November 6, 2014 Received: November 10, 2014

Dear Ms. Fitch:

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

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Page 2 - Ms. Leslie Fitch

(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 (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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Lori A. Wiggins -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143220

Device Name

SIDEKICK® EZ FRAME™ External Fixation System

Indications for Use (Describe) Wright's SIDEKICK® EZ FRAME™ External Fixation System is intended for:

· Triple Arthrodesis
· Isolated Rearfoot Arthrodesis
· Midfoot Arthrodesis
Comminuted Trauma
· Diabetic Charcot Reconstruction
· Most foot pathology not requiring fixation above the ankle

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

01 867 9971 mt.com

510(K) SUMMARY

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. 1023 Cherry Road Memphis, TN 38117
Date:	November 6, 2014
Contact Person:	Leslie Fitch, PhD Senior Regulatory Affairs Specialist Office: (901) 867-4120 Fax: (901) 867-4190
(a)(2). Proprietary Name:	SIDEKICK® EZ FRAME™ External Fixation System
Common Name:	External Fixation System
Classification Name and Reference:	21 CFR 888.3030 – Class II
Device Product Code, Device Panel:	KTT, Orthopedic
(a)(3). Predicate Devices:	K130044: SIDEKICK® EZ FRAME™ External Fixation System

(a)(4). Device Description

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(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

(a)(6). Technological Characteristics Comparison

The SIDEKICK® EZ FRAMETM External Fixation System is technologically substantially equivalent to predicate devices in material and design,

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

Through technological 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 any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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.