The Hoffmann® II Pelvic Clamp is an external fixation frame component 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

The subject Hoffmann® II Pelvic Clamp is used with the components in the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax™ External Fixation System to stabilize fractures of the pelvis using Apex® Pins. The Hoffmann® II Pelvic Clamp is a modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint and is made from stainless steel and aluminum with threaded locking bolts.

AI/ML Overview

The provided text describes a 510(k) summary for the Hoffmann® II Pelvic Clamp, a mechanical device used for external bone fixation. It is not a report about an AI/ML powered medical device. Therefore, much of the requested information (such as AI performance metrics, ground truth establishment for AI, expert adjudication, MRMC studies, and training/test set details) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device, as this is the basis for its 510(k) clearance.

Here's an interpretation based on the provided text, recognizing the limitations for AI/ML-specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

For mechanical devices like the Hoffmann® II Pelvic Clamp, "acceptance criteria" and "device performance" in the context of a 510(k) typically refer to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through bench testing to show equivalent mechanical properties and functionality.

Acceptance Criteria / Performance Indicator	Reported Device Performance
Mechanical Performance / Equivalence	"Testing has been conducted on the Hoffmann® II Pelvic Clamp demonstrating substantial equivalence to the predicate 30 Degree Pelvic Double Ball Joint."
Material Equivalence	Made from stainless steel and aluminum, similar to other components in the Hoffmann® systems and predicate devices.
Design Equivalence	Described as a "modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint," implying similar design principles.
Intended Use Equivalence	Intended for "stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments," which is consistent with the predicate device's use within the Hoffmann® External Fixation System.

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

Sample Size: Not explicitly stated. For mechanical devices, this would typically involve a certain number of manufactured units subjected to specific mechanical tests (e.g., fatigue, static load). The document only states "Testing has been conducted."
Data Provenance: Not applicable in the context of data (e.g., country of origin, retrospective/prospective). The "data" here refers to the results of mechanical bench tests.

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

Not applicable. This is a mechanical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for a mechanical device is its adherence to engineering specifications and performance benchmarks established through standardized tests.

4. Adjudication method for the test set

Not applicable. This is not an observational or diagnostic AI/ML study.

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 a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical device.

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

For this mechanical device, the "ground truth" or standard for comparison is provided by the performance of the predicate device (Hoffmann® 30 Degree Pelvic Double Ball Joint) and relevant engineering standards or internal specifications for mechanical strength, durability, and functionality. The study aimed to demonstrate that the new device met these established benchmarks, thereby proving substantial equivalence.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML system.

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

Not applicable. This is a mechanical device, not an AI/ML system.

Summary of the Study for Substantial Equivalence:

The study conducted was a bench testing study designed to demonstrate that the Hoffmann® II Pelvic Clamp is substantially equivalent to its predicate device, the Hoffmann® 30 Degree Pelvic Double Ball Joint.

Objective: To show equivalence in intended use, materials, and design.
Methodology: "Testing has been conducted on the Hoffmann® II Pelvic Clamp." While specific test types (e.g., static strength, fatigue testing, torsional rigidity) are not detailed, such tests would typically be performed to compare the mechanical properties of the new clamp against the known properties of the predicate device.
Outcome: The testing demonstrated "substantial equivalence" to the predicate, allowing for FDA clearance. The basis for this equivalence appears to be that the Hoffmann® II Pelvic Clamp is a "modification" of the predicate and utilizes similar materials (stainless steel and aluminum) and is intended for the same clinical application within the same external fixation systems.

Summary

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NOV - 5 2003

510(k) Summary of Safety and Effectiveness for the Hoffmann® II Pelvic Clamp

033145
page 1 of 1

Proprietary Name:	Hoffmann® II Pelvic Clamp
Common Name:	External Fixation Frame Component
Classification Name and Reference	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Device Product Code:	87 LXT
For Information contact:	Vivian Kelly, Regulatory Affairs ConsultantHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677Phone: (201) 831-5581Fax: (201) 831-6038
Date Summary Prepared:	September 29, 2003

Intended Use:

This submission describes an external fixation frame component for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax "External Fixation System and in conjunction with Apex® Pins. External fixation frames are 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.

Description:

Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials and design to the predicate device. Testing has been conducted on the Hoffmann® II Pelvic Clamp demonstrating substantial equivalence to the predicate 30 Degree Pelvic Double Ball Joint.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

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

Re: K033145

Trade/Device Name: Hoffman® II Pelvic Clamp Regulation Number: 21 CFR 3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: LXT Dated: September 29, 2003 Received: September 30, 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,

L. Mark N. Milberson

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 033145

Device Name: Hoffmann® II Pelvic Clamp

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______________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Mark A. Millkerer

estorative

510(k) Number K033145

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.