The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:

Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems; o
Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
Stabilization of non-unions; and 0
Intraoperative temporary stabilization tool to assist with indirect reduction. 0

Device Description

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.

AI/ML Overview

The provided document describes the 510(k) summary for the XtraFix External Fixation System Line Additions, focusing on its substantial equivalence to predicate devices rather than a de novo study with acceptance criteria and performance data. Therefore, many of the requested sections regarding user studies, ground truth, and sample sizes for AI/algorithm performance cannot be extracted directly from this document.

However, based on the information provided, here's what can be stated:

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

Since this is a 510(k) submission for line additions to an existing device, the acceptance criteria are primarily defined by "substantial equivalence" to predicate devices and adherence to relevant industry standards. The performance is demonstrated through mechanical testing.

Acceptance Criteria Type	Acceptance Criteria Description	Reported Device Performance
Substantial Equivalence to Predicate Devices	The new line additions (clamps and half pins) should have similar indications for use and incorporate similar technological characteristics to legally marketed predicate devices.	All evaluations determined that the XtraFix External Fixation System (including the line additions) is substantially equivalent to the predicate devices (XtraFix External Fixation System K091258 and K111155, Synthes Large External Fixation Clamps- MS K031428, and Smith & Nephew Jet-X Unilateral Fixator K994143).
Mechanical Performance (External Fixation Devices)	Characterization and evaluation according to the requirements outlined in ASTM F1541-02 (2007): Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. This typically involves criteria related to strength, stiffness, fatigue, and other biomechanical properties.	The system was characterized and evaluated according to the requirements outlined in the specified ASTM standard and FDA guidance. The document states that the principles of operation are the same as for the predicates, implying that the performance meets the established benchmarks for external fixation devices. Specific performance values (e.g., stiffness values, failure loads) are not provided in this summary.
MR Safety and Compatibility	Characterization and evaluation according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This typically involves assessing magnetic fields, RF heating, and image artifact.	Testing confirmed the devices can be used in an MR environment under predetermined conditions. The term "MR Conditional" can be used to describe the system in accordance with the guidance document, meaning it meets the acceptance criteria for safe use in an MR environment under specific conditions.

Regarding the remaining questions, the provided 510(k) summary does not contain information about:

2. Sample size used for the test set and the data provenance: This document describes mechanical and MR compatibility testing, not clinical or AI/algorithm performance studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical images/data requiring human interpretation for ground truth were part of this 510(k) submission's evidence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical or MR compatibility testing.
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 is a medical device (external fixation system), not an AI algorithm for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical and MR testing, "ground truth" would be established by the physical properties measured against the standard specifications. This is not comparable to clinical ground truth.
8. The sample size for the training set: Not applicable. No AI/algorithm training set was used.
9. How the ground truth for the training set was established: Not applicable. No AI/algorithm training set was used.

Summary of what the document implies for the study:

The study referenced is not a clinical efficacy study involving patient data, but rather benchtop mechanical testing and MR compatibility testing. The primary method for demonstrating "device meets acceptance criteria" is via adherence to established ASTM standards and FDA guidance documents for external fixation devices and MR safety, coupled with successfully proving substantial equivalence to existing predicate devices.

Summary

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JUN 26 2012

XtraFix External Fixation System Line Additions 510(k) Summary

Device Manufacturer:	ExtraOrtho, Inc.8275 Tournament Drive, Suite 160Memphis, TN 38125
Submission Date:	November 16, 2011
Contact Person:	Brian AustinTel: 1-901-748-2581Fax: 1-901-748-2583
Proprietary Name:	XtraFix External Fixation System Line Additions
Common Name:	External Fixation Frame Components
Classification regulation:	888.3030 Single/multiple component metallic bonefixation appliances and accessories, 888.3040 Smooth orthreaded metallic bone fixation fastener
Device Class:	Class II
Product Codes:	KTT and JDW/ Orthopedics/87

Device Description and Intended Use:

The XtraFix External Fixation System includes various elements designed to build a fixator construct. The line additions include new clamps and half pins.

Stabilization of open or closed fractures, typically in the context of polytrauma or o where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems; o
Stabilization of limbs after removal of total joint arthroplasty for infection or other 0 failure;
Stabilization of non-unions; and 0
Intraoperative temporary stabilization tool to assist with indirect reduction. 0

Predicate Devices:

The XtraFix External Fixation System Line Additions are similar to several predicates including the following:

XtraFix External Fixation System (K091258 and K111155); .
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KI) 3383

XtraFix External Fixation System Line Additions 510(k) Summary

Synthes Large External Fixation Clamps- MR S (K031428); and
Smith & Nephew Jet-X Unilateral Fixator (K994143).

Technological Characteristics

The principles of operation of the XtraFix External Fixation System Line Additions are the same as for the predicates. The system was characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007), Standard Specification and Test Methods for External Fixation Devices and the FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. The XtraFix External Fixation System Line Additions were also characterized and evaluated according to the requirements outlined in FDA Guidance document, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." Testing confirmed the devices can be used in an MR environment under predetermined conditions. Therefore, the term "MR Conditional" can be used to describe the system in accordance with the guidance document.

Substantial Equivalence Information:

The XtraFix External Fixation System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the XtraFix External Fixation System is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

Public Health Service

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

JUN 26 2012

Extraortho, Inc. c/o Marcos Velez-Duran President of MSquared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K113383

Trade/Device Name: XtraFix External Fixator 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, JDW Dated: April 6, 2012 Received: April 9, 2012

Dear Mr. Velez-Duran:

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

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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/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.

Sincerely yours,

Eunice Keith

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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K11 33883

Indications for Use Statement

To be assigned 510(k) Number:

XtraFix External Fixation System Device Name:

Indications for Use: The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system i is intended for:

Stabilization of open or closed fractures, typically in the context of polytrauma or O where open or alternative closed treatment is undesirable or otherwise contraindicated;

o Arthrodesis and osteotomies with associated soft tissue problems;
o Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
Stabilization of non-unions; and 0
Intraoperative temporary stabilization tool to assist with indirect reduction. O

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Autsit

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113383

Page 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.