The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

Device Description

This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Micro "External Fixation System. The subject and predicate Hoffmann® II Micro" External Fixation Systems are both fabricated from stainless steel components and carbon connecting rods.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Hoffmann® II Micro™ External Fixation System Line Extension. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about clinical studies with human participants, expert review, or AI algorithms. Therefore, many of the requested sections about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance, reader studies, and ground truth cannot be extracted from this specific document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria (Mechanical)	Reported Device Performance
Comparable mechanical properties to predicate components.	Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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

Sample Size: Not specified for the mechanical testing.
Data Provenance: Not applicable. The "study" referenced is mechanical testing, not a clinical data study.

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. This was mechanical testing, not a study requiring expert consensus or ground truth in the medical diagnostic sense.

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

Not applicable. This was mechanical 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

No. This document does not pertain to AI or human reader studies.

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

No. This document is about a mechanical external fixation system, not an algorithm.

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

For the mechanical testing: The "ground truth" was compliance with established engineering performance standards, as demonstrated by the predicate device's mechanical properties.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Summary

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Summary of Safety and Effectiveness Hoffmann® II Micro™ External Fixation System Line Extension

Proprietary Name: System

Common Name:

Classification Name and Reference

Device Product Code:

For Information contact:

Hoffmann® II Micro™ External Fixation

External Fixation Frame Component

Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030

87 KTT, 87 LXT & 87 JEC

Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 831-5581 Fax: (201) 831-6038

Date Summary Prepared:

December 5, 2003

Description:

Intended Use:

The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other mcans of internal fixation.

Substantial Equivalence:

The subject Hoffmann® II Micro " External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Micro™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract caduceus symbol, which is a symbol associated with healthcare and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 0 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Stryker Howmedica Osteonics, Corp. 59 Route 17 South Allendale, NJ 07401

Re: K033476

Trade/Device Name: Hoffmann® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastener, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codc: KTT, LXT, JEC Dated: January 6, 2004 Received: January 7, 2004

Dear Ms. Kelly:

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 Amendnients, 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. 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 (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 8,07.97). 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,

l Mark n Wilkerson

elia M. Witten, Ph.D., M.D., M.D 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): K033476

Device Name: Hoffmann® II Micro External Fixation System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

for Mark A. Millman

K033476

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.