This subject component, when used together with the components of the Hoffmann® II and/or Monotube® TRIAX™ External Fixation Systems and Apex® Pins, creates an external fixation frame construct. The subject device is intended to be used in the construction of external fixation frames 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.

The Hoffmann® II Hybrid External Fixation System is intended to be used in conjunction with the Apex™ Half Pins of the Hoffmann® External Fixation System and Kirschner Wires of the Monticelli Spinelli™ External Fixation System, and may be used as a Hybrid External Fixation System with the components of the Hoffmann® II External Fixation System and the Monotube® TRIAX™ External Fixation System.

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 metallic 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 Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.

AI/ML Overview

This document is a 510(k) Premarket Notification for a modified medical device, the Hoffmann® II Hybrid Ring Clamp. The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (K000197).

Therefore, this type of submission does not typically contain acceptance criteria or a study proving device performance in the way a novel device might. Instead, the "study" is a technological comparison to the predicate device to show that the modifications do not alter the safety or effectiveness of the device.

Here's how to address your numbered points based on the provided text:

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

This information is not provided in the document. For a 510(k) modification demonstrating substantial equivalence, the "acceptance criteria" are typically that the modified device's performance (e.g., mechanical properties, material properties) is comparable to the predicate device and that the modifications do not raise new questions of safety or effectiveness. The reported "performance" would be the results of the comparison testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify a distinct "test set sample size" in terms of number of patients or clinical cases. The "testing" involved a technological comparison of the modified clamp to the predicate device. This would typically involve in-vitro mechanical testing of components or assemblies. The sample size for such tests (e.g., number of clamps tested for strength) is not stated.
Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data would originate from the manufacturer's internal testing facilities, likely in the US (where Howmedica Osteonics Corp is based). The study is essentially a retrospective comparison to the predicate device's established performance and a comparison of the new manufacturing process/design.

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)

This is not applicable as there is no "ground truth" derived from expert consensus on clinical data or images. The "ground truth" in this context is the established performance and safety profile of the predicate device, against which the modified device is compared through engineering analysis and potentially mechanical testing.

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

This is not applicable as there is no clinical test set requiring expert adjudication. The comparison is based on engineering principles and potentially laboratory testing.

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

This is not applicable. This device is a mechanical component (a surgical clamp), not an AI-driven diagnostic or assistive tool for human readers.

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

This is not applicable. This device is a mechanical component.

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

As explained above, there isn't "ground truth" in the typical clinical sense. The "ground truth" for the comparison is the performance and safety established for the predicate device (K000197), primarily through engineering specifications, material properties, and mechanical testing, which the new device aims to match or exceed.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This is not applicable. (See point 8)

Summary of the "Study" from the Document:

The "study" or basis for this 510(k) submission is described as a "Statement of Technological Comparison":

"Analysis demonstrates comparable properties of the subject to the predicate device."

This indicates that the manufacturer performed an engineering analysis, likely involving:

Comparison of materials
Comparison of design specifications (dimensions, geometry)
Comparison of manufacturing processes (to ensure the modifications did not negatively impact performance)
Potentially, mechanical testing (e.g., strength, fatigue, corrosion resistance) to verify that the modified clamp's performance characteristics are equivalent to or better than the predicate device.

The acceptance criteria implicitly would be that the modified device maintains the same level of safety and effectiveness as the predicate device, as demonstrated by these comparable properties. The "device performance" reported is simply that this comparability was achieved.

Summary

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JUL 1 3 2001

K011948

Special 510(k) Premarket Notification

Summary of Safety and Effectiveness Hoffmann® II Hybrid Ring Clamp

Submission Information

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

Contact Person:

Date of Summary Preparation:

Device Identification

Proprietary Name:

Common Name:

Classification Name and Reference:

Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 Karen Ariemma Regulatory Affairs Specialist June 20, 2001

Hoffmann® II Hybrid Ring Clamp External Fixation Frame Component Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030

Predicate Device Identification

The Hoffmann® II Hybrid Ring Clamp was determined substantially equivalent via 510(k) K000197.

Device Description

The Hoffmann® II Hybrid Clamp is being modified to address issues in manufacturing.

Intended Use:

Statement of Technological Comparison:

Analysis demonstrates comparable properties of the subject to the predicate device.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

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

Re: K011948

Trade/Device Name: Hoffmann® II Hybrid Ring Clamp Regulation Number: 888.3030 Regulatory Class: II Product Code: LXT Dated: June 20, 2001 Received: June 21, 2001

Dear Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 N. Melkerson

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): Koj 1948

Device Name: Hoffmann® II Hybrid Frame System

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)

for Mark Milliken (Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K011948
---------------	---------

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.