The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

Device Description

The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.

AI/ML Overview

The provided 510(k) summary for the Dyna-EXTOR® II External Fixation System does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy, which are typical for AI/ML-based devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on materials, configuration, indications for use, and through comparative testing to established standards.

Therefore, many of the requested details (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable to this type of submission, which is for a physical medical device (an external fixation system) and not an AI/ML diagnostic or prognostic tool.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Compliance with ASTM F1541-02 requirements for external fixation devices.	Testing was conducted according to ASTM F1541-02. (Implies compliance, as the device received 510(k) clearance).
Material Equivalence: Materials used are substantially equivalent to predicate devices.	Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to materials used."
Configuration Equivalence: Configuration is substantially equivalent to predicate devices.	Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to...configuration."
Indications for Use Equivalence: Indications for Use are substantially equivalent to predicate devices.	Stated as "substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to...indications for use."

Note: For physical devices like this external fixation system, "acceptance criteria" and "device performance" primarily revolve around meeting recognized industry standards (like ASTM F1541-02) and demonstrating equivalence in design and function to devices already on the market. There are no performance metrics like sensitivity or specificity because it's not a diagnostic or AI/ML device.

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

Not applicable. The submission references "testing conducted according to ASTM F1541-02." This typically involves laboratory mechanical testing of device prototypes or production samples, not clinical data sets with "test sets" in the context of AI/ML. The provenance of such mechanical testing data is usually the manufacturer's R&D or an accredited testing lab.

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. "Ground truth" in the context of this device would refer to the physical and mechanical properties of the materials and component designs, which are verified through engineering tests against established standards, not expert clinical consensus on a "test set."

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

Not applicable. As there is no clinical "test set" requiring human interpretation or consensus, no adjudication method is relevant here.

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 an external fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is compliance with mechanical and material specifications as defined by engineering standards (e.g., ASTM F1541-02) and demonstrated equivalence to physically manufactured predicate devices. This is established through laboratory testing and engineering analysis.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an external fixation system.

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

Not applicable. There is no "training set" for this device.

Summary

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K110426 (pg 1/2)

NOV - 2 2011

510(k) Summary

Submitted on behalf of:

Company Name:	BK Meditech Co, Ltd
Address:	215-5 Yodang-Li, Yanggam-MyunHwasung-Si, Kyunggi-DoRepublic of Korea 445-931
Telephone:	82-133529135
Fax:	82-313529134

by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

CONTACT PERSON:
DATE PREPARED:
TRADE NAME:
COMMON NAME:
CLASSIFICATION NAME:
PRO CODE:

Telephone:

Fax:

Elaine Duncan October 12, 2011 Dyna-EXTOR® II External Fixation System External Fixation System bone fixation fastener KTT

SUBSTANTIALLY EQUIVALENT TO:

This system is substantially equivalent to Howmedica Mono-tube system and components, Orthofix Penning system and Orthofix Minirail system and the Stryker-Howmedica Apex Pin according to materials used, configuration, indications for use, and as shown by comparative testing and testing to standards.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

510(k) Submission

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510(k) Summary-Continued

The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extraarticular fractures, corrective osteotomies, and soft tissue deformities.

Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

SUMMARY of TESTING:

Testing was conducted according to ASTM F1541-02.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

BK Meditech Co, Ltd. % Paladin Medical Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Bo 560 Stillwater, Minnesota 55082

NOV - 2 2011

Re: K110426

Trade/Device Name: Dyna-EXTOR II 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 Dated: October 12, 2011 Received: October 14, 2011

Dear Ms. Duncan:

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-interstatecommerce 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

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Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC

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.

Sincerely yours,

Ernst 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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Indications for Use

510(k) Number (if known): K | 0426 (pg |/ |)

Device Name: Dyna-EXTOR II External Fixation System

Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

Prescription Use X (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)

Michael

Page 1 of 1

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

510(k) Number K110426

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.