The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex" Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX " External Fixation System.

This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.

Device Description

This Special 510(k) submission is a line extension intended to add an alternate style of coupler to the Hoffmann® II External Fixation System.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Hoffmann® II Rod to Wire Coupling, a line extension to an existing external fixation system. The submission aims to demonstrate substantial equivalence to predicate devices through mechanical testing.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Properties Comparable to Predicate Devices	"Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices."
Same Intended Use	"The subject Hoffmann® II Rod to Wire Coupling shares the same intended use... as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System."
Basic Design Concepts	"The subject Hoffmann® II Rod to Wire Coupling shares... basic design concepts as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System."

Study Proving Device Meets Acceptance Criteria:

A study involving "Mechanical testing" was conducted to demonstrate comparable mechanical properties to the predicate components. This testing was used to support the claim of substantial equivalence.

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

The document does not explicitly state the sample size used for the mechanical testing (i.e., the "test set"). It also does not provide details about data provenance (e.g., country of origin, retrospective or prospective).

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

The concept of "experts" to establish ground truth is generally applicable to studies involving human interpretation (e.g., medical imaging). For mechanical testing, the "ground truth" would be established by the physical properties and performance metrics determined through the testing methodology. The document does not mention any human experts establishing ground truth for the mechanical testing.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human readers to resolve discrepancies in assessments. This is not relevant to the mechanical testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a mechanical testing comparison to predicate devices, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical device (an external fixation component), not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the study was established through mechanical testing. This involves objective measurement of physical properties (e.g., strength, stiffness, fatigue resistance) according to established engineering standards or protocols.

8. The Sample Size for the Training Set

The document does not describe a "training set" as this is a mechanical device, not a machine learning model.

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

Not applicable, as there is no "training set" for this type of device and study.

Summary

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K05349 p½

DEC 9 2005

Summary of Safety and Effectiveness Hoffmann® II Rod to Wire Coupling

Proprietary Name:	Hoffmann® II Rod to Wire Coupling
Common Name:	External Fixation Frame Components
Classification Name and Reference	Single/multiple component metallic bonefixation appliances and accessories, 21 CFR§888.3030
Device Product Code:	87 KTT
For Information contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038
Date Summary Prepared:	December 1, 2005

Description:

This Special 510(k) submission is a line extension intended to add an alternate style of coupler to the Hoffmann® II External Fixation System.

Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile and nonsterile external fixation frames intended to provide stabilization of open and/or unstable fractures. The indications for use for the Hoffmann® II Rod to Wire Coupling are provided below.

Indications for Usc:

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Image /page/1/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'K053349 r/2'. The characters are written in a cursive style, and the contrast between the ink and the background is high, making the text easily readable.

Substantial Equivalence:

The subject Hoffmann® II Rod to Wire Coupling shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II External Fixation System and Hoffmann® II Hybrid Frame System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus-like symbol with three parallel lines that curve and converge at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.

DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Francisco Haro Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K053349

K053349
Trade/Device Name: Hoffmann® II Rod to Wire Coupling Regulation Number: 21 CFR 888.3030 Regulation Number: 21 CFR 886.5030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 30, 2005 Received: December 2, 2005

Dear Mr. Haro:

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the indication were and the clearing is substantially equivalent (for the indica We have reviewed your Section > IQK) premaise in substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have deemined the levices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally interest declical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food, Drug, commerce prior to May 28, 1976, the enactions of the Federal Food, Drug, devices that have been reclassified in accounted with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls You may, therefore, market the device, subject or the general registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Incrude requirements of the samally and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito entitle cass if creasur som alleoting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional controls: Listing major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regulations, This 24, 2017
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 Please be advised that FIAA's ssuance of a substantial with other requirements of the Act
that FDA has made a determination that your device complies with other requirements. that FDA has made a determination in a your device complet Federal agencies. You must
or any Federal statutes and regulations administered by registration and listing or any Federal statutes and regulations and united to: registration and listing (21 list.
comply with all the Act's requirements, including, but not ice reguirements as sct comply with all the Act 5 requirements, including, out manufacturing practice requirements as sch
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the d CFR Part 807); labeling (21 CFR Parl 801), good manifacture, policable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, 1050 forth in the quality systems (QS) regulation (21 -51 re reases)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Francisco Haro

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maketing of substantial equivalence of your device to a legally premarket notheation. THC PDA miding of cassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our lateling regulation (11 CFR Part 801), please If you desire specific advice for your do not one one one the regulation entitled, the regulation entitled, the open abtering contact the Office of Comphalled at (210) = 16 = 21 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misbranding by reference to premation notifications in the Act from the Division of Small other gelleral information on your responsive at its toll-fire number (800) 638-2041 or 1988)
Manufacturers, International and Consumer Assistance at in him between worldings Manufacturers, International and Consumer Abstrance arov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOS 3349

Device Name: Hoffmann® II Rod to Wire Coupling

Indications for Use:

The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the The Tionnalir - 11 17 Joria External Fixation System and Kirschner Wires of the Monticelli Pipel "Tall " External Fixation System, and may be used as a Hybrid External Fixation System with the Spinch - External Pixation System, and the Monotube® TRIAX™ External Fixation System.

This device is used to provide stabilization of open and/or unstable fractures and where soft r ms device is used to pro ria ease of other fracture treatments such as IM rods, casts, or other means of internal fixation.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
-------------------------------------------------	---	--------	------------------------------------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K053349
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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.