HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM by HOWMEDICA CORP.

The Hoffmann® II Compact External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting. And other means of internal fixation.

Device Description

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, recognizing that this document is a 510(k) summary for a medical device and not a detailed study report. Therefore, some information like "sample size for the test set" or specific "effect size" for MRMC studies will not be present as these are not typically found in a 510(k) summary for such a device. This document focuses on demonstrating substantial equivalence through comparison to predicate devices, primarily via material, design, and operational principles, rather than clinical performance studies with acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study. Instead, it asserts substantial equivalence based on similarities to predicate devices. The "acceptance criteria" are implied to be the successful demonstration of equivalence in:

Acceptance Criterion (Implied)	Reported Device Performance (as stated in 510(k))
Intended Use Equivalence	"Intended to be used in conjunction with the Half Pins and Transfixing Pins of the Hoffmann® External Fixation System and may be used with the components of the Hoffmann® II External Fixation System." "Intended to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments." (Same as predicate devices)
Material Equivalence	"Manufactured from Stainless Steel and Aluminum." (Equivalent to Hoffmann® II External Fixation System; Original Hoffmann® Components are Stainless Steel).
Design Equivalence	"The design of the Hoffmann® II Compact Components, the Hoffmann® II Components and the Original Hoffmann® Components are substantially equivalent."
Operational Principles Equivalence	"Basic operational principles... are to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of Pin Clamps, Couplings and Rods." (Equivalent to other named external fixation systems).
Method of Site Preparation/Indications/Contraindications	"The method of site preparation, relative indications and contraindications for all of the external fixation systems are similar."
Mechanical Performance (Implied by testing)	"Testing compares the performance of the new components with the components of the Original Hoffmann® System or the Hoffmann II External Fixation System." (Specific test results or acceptance limits are not provided in this summary, but the assertion is that performance is comparable).

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

Sample Size for Test Set: Not explicitly mentioned. The document states "Testing of the components of this system is presented in this document," but does not detail the number of components tested or the specific test setup quantities.
Data Provenance: Not specified, but standard for 510(k) submissions relies on bench testing data, typically conducted by the manufacturer or a contracted lab. It is not clinical data, so country of origin of data or retrospective/prospective status are not applicable in the clinical sense. This refers to engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for a mechanical device like an external fixator, when establishing substantial equivalence through bench testing, is typically based on engineering specifications, recognized standards (if applicable), and comparison to the predicate device's established performance characteristics. It does not involve expert clinical consensus on "ground truth" labels for a test set in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic or clinical study with human interpretation, there's no "adjudication method" in the sense of resolving conflicting expert opinions. Mechanical testing results are objective measurements against defined criteria.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and it is not relevant for this type of device (mechanical external fixator). MRMC studies are typically performed for diagnostic imaging AI devices to assess the impact of AI on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This device is a mechanical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established mechanical performance characteristics and design specifications of the predicate devices (Original Hoffmann® External Fixation System and Hoffmann® II External Fixation System). The new device's components were likely tested against engineering standards and compared to the performance of these predicate devices to demonstrate equivalence. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a mechanical device.

Summary

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Ka71755 JUL 17 1997

510(k) Summary

Trade Name: Common Name: Classification Name: Hoffmann® II Compact External Fixation System External Fixation Device Smooth or Threaded Metallic Bone Fixation Fastener 888.3040

This submission describes a system of external fixation components consisting of Rodto-Rod Couplings, Pin-to-Rod Couplings, Straight and Angled Posts, a Pin Clamp Assembly, Compression/Distraction Rod-to-Rod Coupling, a Compression/Distraction Rod and Curved and Straight 5mm Rods. These components are intended to be used in conjunction with the Half Pins and Transfixing Pins of the Hoffmann® External Fixation System and may be used with the components of the Hoffmann® II External Fixation System. This device is intended 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 rodding, casting, or other means of internal fixation.

Equivalency of this system is based on similarities in intended use, materials, design and operational principles to the Original Hoffmann® External Fixation System and the Hoffmann® II External Fixation Systems. All of these devices are intended to be used in an external fixation frame for the stabilization of bone fragments.

The Hoffmann® II Compact External Fixation Components and the Hoffmann® II External Fixation System are both manufactured from Stainless Steel and Aluminum. The Original Hoffmann® Components are manufactured from Stainless Steel.

The design of the Hoffmann® II Compact Components, the Hoffmann® II Components and the Original Hoffmann® Components are substantially equivalent.

The basic operational principles for the construction of the Hoffmann® II Compact External Fixation System, as well as the other named external fixation systems, are to provide external stabilization of a fracture by means of percutaneous pins connected to a frame by means of Pin Clamps, Couplings and Rods. The method of site preparation, relative indications and contraindications for all of the external fixation systems are similar.

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K971755

Testing of the components of this system is presented in this document. Testing compares the performance of the new components with the components of the Original Hoffmann® System or the Hoffamnn II External Fixation System.

For information contact:

John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7386 Fax: (201) 507-6870

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John F. Dichiara Group Requlatory Affairs Manager Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

JUL 17 1997

Re : K971755 Hoffmann® II Compact External Fixation System Regulatory Class: II Product Code: JEC Dated: May 8, 1997 Received: May 12, 1997

Dear Mr. Dichiara:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 - Mr. John F. Dichiara

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of general and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Not Known

Device Name: Hoffmann® II Compact External Fixation System

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)
OR
Over-The-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
(Optional Format 1-2-96)
`K971755

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.