The Hoffmann Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:

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

Device Description

This Special 510(k) submission is intended to addition of 500mm (length)/15mm (diameter) connecting tubes to the predicate Hoffmann Light System, now known as Hoffmann Xpress System.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Hoffmann Xpress Line Extension." This device is an extension of an existing external fixation system, and the submission focuses on adding new connecting tube sizes.

Based on the content, the study conducted is a mechanical and functional testing study to demonstrate that the new components (500mm (length)/15mm (diameter) connecting tubes) are comparable to the predicate device. This is not a study assessing AI performance or human reader performance.

Therefore, most of the requested information (related to AI, human readers, ground truth establishment, training sets, etc.) is not applicable to this type of device and submission.

Here's a breakdown of the relevant information from the document:

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

Acceptance Criteria	Reported Device Performance
Mechanical properties comparable to predicate device	Demonstrated comparable mechanical properties to the predicate device Hoffmann Xpress (Light) System K073076.
Functional properties comparable to predicate device	Demonstrated comparable functional properties to the predicate device Hoffmann Xpress (Light) System K073076.

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 explicitly stated in the provided 510(k) summary. For mechanical tests, this typically refers to the number of components tested under various conditions (e.g., fatigue, static strength).
Data Provenance: Not specified. It's safe to assume the testing was conducted in a controlled laboratory environment. Retrospective or prospective designations are not applicable to this type of mechanical testing.

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. Ground truth in this context would be defined by engineering specifications and standards for mechanical testing, not expert clinical interpretation.

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

Not applicable. Adjudication methods are relevant for subjective interpretations (like medical imaging diagnoses). Mechanical testing relies on objective measurements and comparison to predefined acceptance limits.

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, not applicable. This is not an AI-assisted device.

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

No, not applicable. This is not an software/AI algorithm.

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

For mechanical testing, the "ground truth" is typically established by:
- Engineering specifications and standards: These define the required performance characteristics (e.g., strength, durability, material properties).
- Predicate device performance: The performance of the previously cleared device (Hoffmann Xpress (Light) System K073076) serves as the benchmark against which the new components are compared.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or training sets.

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

Not applicable.

Summary

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Special 510(k)

X092834

510(k) Summary of Safety and Effectiveness: HOFFMANN XPRESS LINE EXTENSION

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:

For Information contact:

Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

OCT - 8 2009

Melissa A. Matarese, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5116 Fax: (201) 831-4116

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name: Classification Name and Reference:

Device Product Code:

September 14, 2009

Hoffmann Xpress Line Extension

External fixation frame components Single/multiple component metallic bone fixation appliances and accessories, 21 CFR §888.3030 KTT

Description:

This Special 510(k) submission is intended to addition of 500mm (length)/15mm (diameter) connecting tubes to the predicate Hoffmann Light System, now known as Hoffmann Xpress System.

Intended Use:

The Hoffmann Xpress Line Extension does not alter the intended use of the predicate systems as cleared in their respective premarket notifications for use for the subject tubes are provided below.

Indications for Use:

The Hoffmann® Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:

Bone fracture fixation; .
:":": ● Osteotomny;
Arthodesis; .
Correction of deformity; .

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Revision procedures where other treatments or devices have been unsuccessful; .
. Bone reconstruction procedures.

Statement of Technological Comparison:

The subject and predicate devices are made from an aluminum alloy (AlMgSi) and Linear Low Density Polyethylene (LLDPE). Functional and mechanical testing demonstrates the comparable mechanical and functional properties of the subject Hoffmann Xpress Line Extension to the predicate device Hoffmann Xpress (Light) System K073076.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp. % Ms. Melissa A. Matarese Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

OCT - 8 2009

Re: K092834

Trade/Device Name: Hoffmann Xpress 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: September 14, 2009 Received: September 15, 2009

Dear Ms. Matarese:

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Melissa A. Matarese

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K092834

510(k) Number (if known): #

Device Name: Hofmann Xpress Linc Extension

Indications For Use:

The Hoffmann Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

AND/OR

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Doneta der MXN

vision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092834

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.