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

Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated;
Stabilization of fractures in the context of polytrauma; .
Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
Arthrodesis and osteotomies with associated soft tissue problems; .
Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
Neutralization of fractures stabilized with limited internal fixation; .
Stabilization of non-unions; and
Intraoperative temporary stabilization tool to assist with indirect reduction.

Device Description

The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Extrafix External Fixation System, focusing on the requested information.

It's important to preface this by stating that the provided document K091258 is a 510(k) summary for a medical device that is not an AI/ML powered device. It's a traditional mechanical medical device (external fixation system). Therefore, several of the requested categories related to AI/ML performance studies, ground truth, experts, and training sets will not be applicable or present in this type of submission.

Acceptance Criteria and Study for Extrafix External Fixation System (K091258)

As the Extrafix External Fixation System is a mechanical device, its "acceptance criteria" are related to its physical and functional performance and safety, rather than diagnostic or prognostic accuracy metrics typical of AI/ML devices. The "study" proving it meets these criteria is a characterization and evaluation against recognized standards and guidance documents for external fixation devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Test Standard	Reported Device Performance	Comments
Mechanical Performance:
ASTM F1541-02 (2007)	Demonstrated compliance	This standard specifies requirements and test methods for external fixation devices, covering aspects like static mechanical properties (e.g., stiffness), cyclic mechanical properties (e.g., fatigue), and material biocompatibility. The summary indicates the device was "characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2007)". No specific numerical performance values are given in this summary document, but compliance implies meeting the standard's thresholds.
Material/Biocompatibility:	Demonstrated compliance	Included implicitly within ASTM F1541-02, which covers material requirements.
Design/Manufacture:	Demonstrated compliance	Follows Good Manufacturing Practices (GMP) implicitly required by FDA.
Intended Use:	Meets stated indications	The device is deemed suitable for the specified indications for use, which are broad and cover various fracture types and scenarios.
Substantial Equivalence:	Substantially Equivalent	The primary "acceptance" for a 510(k) is proving substantial equivalence to predicate devices, meaning it is as safe and effective. This was determined to be met.

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

Sample Size for Test Set: Not applicable in the context of an AI/ML "test set" for performance evaluation. For a mechanical device, the testing is done on physical samples of the device components. The number of samples tested for each part of ASTM F1541-02 is not specified in this summary but would be defined by the standard itself (e.g., n=5 or n=6 for static tests, n=3 for fatigue, etc.).
Data Provenance: Not applicable in the human data sense. The "data" comes from laboratory testing of the manufactured device components.

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

Not applicable. This device is not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from patient data. The "ground truth" for a mechanical device is established by objective physical measurements and adherence to engineering standards. The FDA reviewers are the regulatory experts who assess the submitted data against regulations and standards.

4. Adjudication Method for the Test Set

Not applicable. There is no expert review or adjudication of interpretive results for this type of device. Performance is objectively measured through physical 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 mechanical device, not an AI/ML system. Therefore, no MRMC study, human reader improvement metric, or AI assistance is relevant.

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

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

7. The Type of Ground Truth Used

For a mechanical medical device, the "ground truth" is based on:
- Engineering specifications and design requirements: Does the device meet its blueprints and material specifications?
- Adherence to recognized standards: Does the device perform as required by ASTM F1541-02?
- Safety and Effectiveness: Is the device proven to be as safe and effective as legally marketed predicate devices? This is the ultimate "ground truth" for a 510(k) submission.

8. The Sample Size for the Training Set

Not applicable. There are no "training sets" for mechanical devices as understood in machine learning. The design and manufacturing process involves iterative development and testing, but not in the sense of an AI training set.

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

Not applicable. As there is no training set in the AI/ML sense, this question is irrelevant. The "truth" in manufacturing involves quality control checks and compliance with design specifications throughout the production process.

Summary

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KO91258

Extrafix External Fixation System 510(k) Summary

Device Manufacturer:	QFX Technologies8275 Tournament Drive, Suite 160Memphis, TN 38125
Submission Date:	July 15, 2009
Contact Person:	Steve MillerTel: 1-831-331-5675Fax: 1-831-440-9837
Proprietary Name:	Extrafix External Fixation System
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

Device Description and Intended Use:

The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated;
Stabilization of fractures in the context of polytrauma; .
Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
Arthrodesis and osteotomies with associated soft tissue problems; .
Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
Neutralization of fractures stabilized with limited internal fixation; .
Stabilization of non-unions; and
Intraoperative temporary stabilization tool to assist with indirect reduction.

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Extrafix External Fixation System 510(k) Summary

Predicate Devices:

The Extrafix External Fixation System is similar to several predicates including the following:

Stryker Hoffmann II MRI External Fixation System (K053472); .
Synthes Large External Fixation Clamps- MR S (K031428); and .
Smith & Nephew Jet-X Unilateral Fixator (K994143). .

Technological Characteristics

The Extrafix External Fixation 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.

Substantial Equivalence Information:

The Extrafix 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 Extrafix 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 a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

OFX Technologies, Inc. % M Squared Associates, Inc. Mr. Marcos Velez-Duran President 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K091258

9200 Corporate Boulevard Rockville MD 20850

Food and Drug Administration

JUL 2 4 2009

Trade/Device Name: Extrafix External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JDW Dated: April 28, 2009 Received: April 29, 2009

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.

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 mav 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 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.

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Page 2- Mr. Marcos Velez-Duran

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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Chabare Buehrle

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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K091258

Indications for Use Statement

510(k) Number: To be assigned

Device Name: Extrafix External Fixation System

Indications for Use: The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

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

o Temporary stabilization of open or closed acute fractures with soft tissue injuries;
Definitive stabilization of open or closed fractures where open or alternative closed 0 treatment is undesirable or otherwise contraindicated;
Stabilization of fractures in the context of polytrauma: o
Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries; 0
Arthrodesis and osteotomies with associated soft tissue problems; 0
0 Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure;
Neutralization of fractures stabilized with limited internal fixation: o
Stabilization of non-unions; and 0
o Intraoperative temporary stabilization tool to assist with indirect reduction.

Prescription Use X

AND/OR

Over-The-Counter Use __

(Part 21 CFR 801 Subpart D)

(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)

Smita for mum
(Division Sign-Off)

Division of Surgical, Orthopodic, and Restorative Devices

510(k) Number K091258

Page 1 of

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.