HOFFMANN II COMPACT BALTIMORE COUPLING by HOWMEDICA OSTEONICS CORP.

The Hoffmann® II Compact™ Baltimore Coupling is intended to be used with the components of the Hoffmann® II Compact™ External Fixation System and in conjunction with the half pins or transfixing pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, or other means of internal fixation.

Device Description

This Special 510(k) submission is intended to address the introduction of a supplemental component to the predicate Hoffmann® II Compact External Fixation System. The subject device, named the Hoffmann® II Compact™ Baltimore Coupling, is a line extension of the Hoffmann® II Compact "Rod to Rod Coupling. The predicate Hoffmann® II Compact™ Rod Coupling is fabricated from stainless steel and aluminum. The subject Hoffmann® II Compact™ Baltimore Clamp is also fabricated from stainless steel and aluminum. The Hoffmann® II Compact™ Baltimore Coupling is a modification of the Hoffmann® II Compact" Rod to Rod Coupling. The modification involves a change to the rod to clamp interface which includes a change in profile, an added lip to provide resistance to rod slippage and chamfered edges to aid in rod insertion. Both the predicate Hoffmann® II Compact™ Rod to Rod Coupling and the subject Hoffmann® II Compact™ Baltimore Coupling will be made available to provide surgeons with a choice of couplings for use with the Hoffman® II Compact™ External Fixation System.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called the Hoffmann® II Compact™ Baltimore Coupling, which is a line extension to an existing external fixation system. This is a submission demonstrating substantial equivalence to a predicate device, not a study showcasing device performance against specific acceptance criteria in the way a clinical trial or algorithm validation would.

Therefore, many of the requested elements for a study proving device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) are not applicable to this type of regulatory submission. This document focuses on mechanical testing to demonstrate comparable properties to an existing, cleared device, rather than a clinical study evaluating diagnostic accuracy or a similar performance metric.

Here's a breakdown based on the information available:

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

The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate component."

Acceptance Criteria	Reported Device Performance
Comparable mechanical properties to predicate device (Hoffmann® II Compact™ Rod to Rod Coupling)	Mechanical testing demonstrated comparable mechanical properties.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in this summary document.
Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the "mechanical testing" implies a laboratory setting, likely conducted by the manufacturer (Howmedica Osteonics Corp in Allendale, NJ, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not expert consensus (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews. Mechanical testing results are objective measurements.

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-assisted device, nor is it a diagnostic imaging device subject to MRMC studies.

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

Not applicable. This is a physical coupling component for an external fixation system, not an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" would be established engineering standards, material properties, and benchmark performance of the predicate device under specific test conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

Not applicable. This is a physical device, not an algorithm that requires a training set.

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

Not applicable. (See #8)

Summary

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Line Extension to the Hoffmann® II Compact External Fixation System Hoffmann® II Compact™ Baltimore Coupling

pecial 510(k) Premarket Notification

JUL 2 4 2003

K031941
page 1 of 1

Summary of Safety and Effectiveness Line Extension to the Hoffmann® II Compact™ External Fixation System -Hoffmann® II Compact™ Baltimore Coupling

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677
Contact Person:	Vivian KellyRegulatory Affairs ConsultantPhone: 201-831-5581Fax: 201-831-6038
Date of Summary Preparation:	June 20, 2003
Device Identification
Proprietary Name:	Hoffmann® II Compact™ Baltimore Coupling
Common Name:	External Fixation Frame Component

Classification Name and Reference: Smooth or threaded metallic bone fixation fastener, 21 CFR §888.3040

The subject Hoffmann® II Compact™ Baltimore Coupling has the same intended use and basic design concepts as the currently available Hoffmann® II Compact™ External Fixation System Rod to Rod Coupling. Mechanical testing demonstrated comparable mechanical properties to the predicate component.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031941

Trade/Device Name: Hoffmann® II Compact™ Baltimore Coupling Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: June 20, 2003 Received: June 24, 2003

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 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 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 - 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" (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 A. Millman

Celia M. Witten, Ph.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): K 031941

Device Name: Hoffmann® II Compact™ Baltimore Coupling

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 Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for Mark n Mckinion
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K031941

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.