The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX™ External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Device Description

This Special 510(k) submission is intended to add additional components to the predicate Hoffmann® II MRI External Fixation System.

AI/ML Overview

This document is a 510(k) premarket notification for Hoffmann® II MRI External Fixation System components. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way a clinical study for an AI/ML device would.

Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of this submission:

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

No acceptance criteria or device performance metrics (e.g., sensitivity, specificity, AUC) are presented in the document. This is a 510(k) for external fixation components, not an AI/ML device, so these types of performance metrics are not applicable in this context. The closest equivalent is stating that "Mechanical testing demonstrated comparable mechanical properties to the predicate components and testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions." However, specific criteria for "comparable" or "safely used" are not detailed.

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. There is no test set in the context of an AI/ML device's performance evaluation. The "testing" mentioned is likely mechanical and MRI compatibility testing of the physical device components, not a dataset of patient images.

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. There is no "ground truth" in the AI/ML sense, as this is a physical medical device.

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

Not applicable. No test set or adjudication method is described.

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 not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would be relevant.

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

Not applicable. This is not an algorithm or an AI/ML device.

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

Not applicable. There is no ground truth, as this is a physical medical device. The "truth" in this context would be governed by engineering standards for mechanical strength and MRI safety.

8. The sample size for the training set

Not applicable. There is no "training set" for physical medical device components.

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

Not applicable. There is no training set or ground truth in the context of this device.

Summary based on the provided document:

The document describes a 510(k) submission for new components to an existing external fixation system. The primary "study" mentioned is mechanical testing and MRI compatibility testing. These tests were conducted to demonstrate that the new components possess "comparable mechanical properties to the predicate components" and can be "safely used in Magnetic Resonance Imaging under predetermined conditions." The document does not provide specific acceptance criteria or detailed results of these tests, which is typical for a 510(k) summary relying on substantial equivalence to a predicate device. This type of submission does not involve clinical studies with human "readers" or "ground truth" as would be required for AI/ML-driven devices.

Summary

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K053472 小

JAN 1 1 2006

Summary of Safety and Effectiveness Hoffmann® II MRI Components

Proprietary Name:	Hoffmann® II MRI External Fixation System
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:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038
Date Summary Prepared:	December 13, 2005

Description:

This Special 510(k) submission is intended to add additional components to the predicate Hoffmann® II MRI External Fixation System.

Intended Use:

The modifications do not alter the intended use of the predicate systems as cleared in its respective premarket notifications. The subject and predicate devices are external fixation frames intended to provide stabilization of open and/or unstable fractures of the upper and lower extremities as well as the pelvic disruptions. The indications for use for the Hoffmann® II MRI External Fixation System are provided below.

Indications for Use:

The Hoffmann II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube * TRIAX * External Fixation Svstem and in comjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injurv precludes the use of other fracture treatments such as 1M rodding or casting.

Substantial Equivalence:

The subject Hoffmann II MRI components share the same intended use, and basic design concepts as that of the currently available Hoffmann® II MRI External Fixation System and Hoffmann II External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and testing in a Magnetic Resonance Environment established that the components could be safely used in Magnetic Resonance Imaging under predetermined conditions.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2006

Ms. Vivian Kelly Howmedica Osteonics Corp. 325 Corporate Dr. Mahwah, New Jersey 07430

Re: K053472

Trade/Device Name: Hoffmann II MRI 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: December 13, 2005 Received: December 14, 2005

Dear Ms. Kelly:

We have reviewed your Scction 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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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- Vivian Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use

510(k) Number (if known):

K053472

Device Name: Hoffmann® II MRI External Fixation System

Indications for Use:

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

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K053472

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.