The Hoffmann® 30 Degree Pelvic Double Ball Joint is intended to be used 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. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of external fixation devices include:

Bone fracture fixation .
Osteotomy .
. Arthrodesis
. Correction of deformity
Revision procedure where other treatments or devices have been unsuccessful ●
Bone reconstruction procedures .

Device Description

The subject Hoffmann® 30 Degree Pelvic Double Ball Joint is a modification of the Hoffmann® 5 Hole Ball Joint. The modification involves lengthening the clamp, adding an additional ball joint, modifying the pin interface and tilting the pin holding portion of the clamp by 30 degrees.

AI/ML Overview

This document describes a 510(k) premarket notification for the Hoffmann® 30 Degree Pelvic Double Ball Joint, an external fixation frame component. The focus of the submission is on demonstrating its substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint, rather than proving performance against specific clinical acceptance criteria in a study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, MRMC study, training set) are not applicable to this type of device submission. The device is a mechanical component, and its "performance" is assessed through engineering testing to ensure it meets the same standards as the predicate device.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Substantial Equivalence to Hoffmann® 5 Hole Ball Joint	Demonstrated through testing that the device is substantially equivalent to the predicate Hoffmann® 5 Hole Ball Joint.
Equivalent Mechanical Integrity/Function to Predicate Device	(Not explicitly detailed, but implied by "Testing has been conducted... demonstrating substantial equivalence")
Compatibility with specified external fixation systems and pins (Hoffmann®, Hoffmann® II, Monotube Triax™, Apex® Pins)	The device is intended to be used with these components, implying testing confirmed compatibility.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a mechanical device, and "test set" in the context of clinical data or imaging algorithms is not relevant here. The testing would be engineering verification and validation, likely using a sample of the manufactured device. The origin of the data would be laboratory-based engineering 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. "Ground truth" in the context of expert consensus on clinical findings is not relevant.

4. Adjudication Method for the Test Set

Not applicable.

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 medical device, not an AI or imaging diagnostic tool.

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

Not applicable.

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

The "ground truth" for this device would be its mechanical properties and performance against established engineering standards and comparison to the predicate device. For example, torque resistance, fatigue life, strength, etc., as determined by laboratory testing. Not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study (Implied by the 510(k) Summary):

The provided text details a 510(k) submission for a medical device: the Hoffmann® 30 Degree Pelvic Double Ball Joint. The "study" referenced is the testing conducted to demonstrate substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint.

Objective: To show that the modified device (Hoffmann® 30 Degree Pelvic Double Ball Joint) is as safe and effective as the legally marketed predicate device (Hoffmann® 5 Hole Ball Joint).
Methodology (Inferred): This involved comparing the new device to the predicate in terms of:
- Intended Use: Both are external fixation frame components.
- Materials: Implied to be similar ("Equivalency of this device is based on similarities in intended use, materials and design...").
- Design: Acknowledged modification (lengthening clamp, additional ball joint, modified pin interface, 30-degree tilt), but implied that these changes do not alter fundamental safety and effectiveness.
- Performance: "Testing has been conducted on the Hoffmann® 30 Degree Pelvic Double Ball Joint demonstrating substantial equivalence to the predicate Hoffmann® 5 Hole Ball Joint." This testing would typically involve mechanical tests (e.g., fatigue, strength, torsional stability) to ensure the new design performs at least as well as the predicate under simulated physiological loads.
Acceptance Criteria (Inferred): The acceptance criteria for the "study" was the demonstration of substantial equivalence to the predicate device. This means the new device met the same performance standards and exhibited similar characteristics to the predicate, even with design modifications. The specific quantifiable criteria (e.g., "must withstand X N-m of torque," or "fatigue life must exceed Y cycles") are not provided in this summary but would be part of the full 510(k) submission's engineering reports.
Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Summary

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K022651 PAGE 1/1

OCT 1 7 2002

510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness for the Hoffmann® 30 Degree Pelvic Double Ball Joint

Proprietary Name:	Hoffmann® 30 Degree Pelvic Double Ball Joint
Common Name:	External Fixation Frame Component
Classification Name and Reference	Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030
Regulatory Class:	Class II
Device Product Code:	87 LXT
For Information contact:	Karen Ariemma, Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, NJ 07401-1677
	Phone: (201) 831-5718
	Fax: (201) 831-6038
Date Summary Prepared:	August 8, 2002

Intended Use:

This submission describes an external fixation frame component when used together 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, creates an external fixation construct. External fixation frames 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 Hoffmann® 5 Hole Ball Joint. Testing has been conducted on the Hoffmann® 30 Degree Pelvic Double Ball Joint demonstrating substantial equivalence to the predicate Hoffmann® 5 Hole Ball Joint.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CT 1 7 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K022651 Hoffmann® 30 Degree Pelvic Double Ball Joint Trade Name: 21 CFR 888.3030 Regulation Number: Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II LXT Product Code: August 8, 2002 Dated: August 9, 2002 Received:

Dear Ms. Ariemma:

Re:

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. Karen Ariemma

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.

Sincerely yours,

l. Mark N-Millican

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K122651

Device Name: Hoffmann® 30 Degree Pelvic Double Ball Joint

Indications For Use:

Bone fracture fixation .
Osteotomy .
. Arthrodesis
. Correction of deformity
Revision procedure where other treatments or devices have been unsuccessful ●
Bone reconstruction procedures .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

(k) Number	K022657
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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.