HOFFMANN LIGHT SYSTEM by HOWMEDICA OSTEONICS CORP.

This submission is a line extension to the Hoffmann® II External Fixation System. The components of the Hoffmann® Light System will be based on the component designs of the Hoffmann® II External Fixation System.

AI/ML Overview

The Hoffmann® Light System is an external fixation system that is a line extension to the Hoffmann® II External Fixation System. The device is indicated for use in bone fracture fixation, osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.

The acceptance criteria for the Hoffmann® Light System are based on its substantial equivalence to the Hoffmann® II External Fixation System in terms of intended use, design, materials, and operational principles. The study that proves the device meets the acceptance criteria demonstrates that the subject components of the Hoffmann® Light System are substantially equivalent in strength to the predicate components of the Hoffmann® II External Fixation System.

Here's the detailed breakdown of the information requested:

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

Acceptance Criteria	Reported Device Performance
Substantially equivalent to Hoffmann® II External Fixation System in intended use, design, materials, and operational principles.	The Hoffmann® Light System's components are based on the designs of the Hoffmann® II External Fixation System, indicating equivalence in design and operational principles. Its intended uses are identical to the predicate.
Substantially equivalent in strength to the predicate components (Hoffmann® II External Fixation System components).	The test results demonstrate that the subject components (Hoffmann® Light System) are substantially equivalent in strength to the predicate components (Hoffmann® II External Fixation System).

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

The provided document does not specify the exact sample size used for the strength testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components."

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

This information is not provided in the document. The acceptance criteria are based on direct physical properties (strength) and design/material equivalence, rather than a clinical ground truth established by medical experts for a diagnostic or AI device.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical evaluations involving human interpretation (e.g., image reading) where ground truth might be ambiguous and require expert consensus. The testing here appears to be mechanical/physical.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human readers interpret medical images or data. The Hoffmann® Light System is an external fixation device, not a diagnostic tool, and does not involve human readers interpreting data for diagnosis.

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

A standalone performance study, as understood for AI algorithms, was not done. The device is a mechanical orthopedic device, not an AI algorithm. Its performance is measured through physical and mechanical testing, not algorithmic accuracy.

7. The type of ground truth used

The "ground truth" for this device's acceptance is based on mechanical testing results (demonstrating equivalent strength) and engineering assessment of design, materials, and operational principles against a legally marketed predicate device. This is a comparison against established engineering standards and the performance of an existing, approved device, rather than a clinical ground truth from pathology or patient outcomes.

8. The sample size for the training set

This information is not applicable and not provided. The Hoffmann® Light System is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable. As stated above, the device is not an AI model with a training set.

Summary

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K073076 (pg 1/1)

510(k) Summary of Safety and Effectiveness Hoffmann® Light System

Proprietary Name:	Hoffmann® Light System
Common Name:	External Fixation Frame Components
Classification Name/Reference:	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Device Product Code:	87 KTT
Proposed Regulatory Class:	Class II	5
For Information contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493 Fax: (201) 831-6038
Date Summary Prepared:	January 28, 2008

Description:

Indications:

Bone fracture fixation; .
. Osteotomy;
. Arthodesis;
. Correction of deformity;
Revision procedures where other treatments or devices have been unsuccessful; .
. Bone reconstruction procedures.

Substantial Equivalence:

The Hoffmann® Light System is substantially equivalent to the Hoffmann® II External Fixation System in regards to intended use, design, materials, and operational principles as an external fixation system. The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FED 5 250

Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

Re: K073076 Trade/Device Name: Hoffman® Light System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation Appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: February 5, 2008 Received: February 6, 2008

Dear Mr. Haro:

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 - Mr. Francisco Haro

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson 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

K073076 (pg 1/1)

510(k) Number (if known):

Device Name: Hoffmann® Light System

Indications for Use:

Bone fracture fixation; .
Osteotomy; .
Arthodesis; .
Correction of deformity; .
Revision procedures where other treatments or devices have been unsuccessful; .
Bone reconstruction procedures. .

Prescription Use Over-The-Counter 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)

Page 1 of 1

Mark A. Millerson

(Division Sigt -Off) Division of General. Rest rative, and Neurological Devices

510(k) Number K073076

Regulation Number and Section

N/A