The Trauma-Fix® External Fixator is offered as both a unilateral (uni-bar) and quadrilateral style (also called multi-plane) external fixation frame. External fixators known as unibar and multi-plane are typical of present industry standard designs. The uni-bar fixator concept is an outgrowth of the multi-plane fixator varying chiefly in the use of half-pins rather than the transfixing pins typical of multi-plane fixation, though occasionally half-pins are used with multi-plane fixators.

The Trauma-Fix® External Fixator line is made up of the following items: Fixator Pin Holder Clamps, 5 & 8 mm diameter Articulation Coupling, 5 & 8 mm diameter Connecting Rods, 5 & 8 mm diameter Adjustable Telescopic Connecting Rods, 5 & 8 mm diameter Small Lengthining Device for Forearm Colles Forearm Frame Half-Pins Full-Pins/Transfixing Pins KTB Wires Uni-Bar Pin Clamp Uni-Bar Smooth Rods Uni-Bar Compression & Distraction Rod Uni-Bar Connector Instruments Drill Brace Chuck, 3, 4, 5, 6, mm T-Wrench Open Wrench Hex Screw Driver Drill Bit Trochar & Sleeve

AI/ML Overview

The provided text is a 510(k) premarket notification for the Trauma-Fix® External Fixator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information cannot be found in this document.

Here's an breakdown of the available and missing information based on the request:

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

This information is not present in the document. The document primarily focuses on a comparison of features to predicate devices to establish substantial equivalence, not on specific performance metrics or acceptance criteria for the Trauma-Fix® External Fixator itself.

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

This information is not present. No specific test set or study data are presented for the Trauma-Fix® External Fixator's performance. The submission relies on the "long standing safety and effectiveness use of the concept" and comparison to predicate devices.

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 information is not present. No test set requiring expert-established ground truth is described.

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

This information is not present. No test set is described.

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 information is not present. The device is an external fixator, not an AI-powered diagnostic tool, so an MRMC study with human readers improving with AI assistance would not be applicable.

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

This information is not present. The device is a physical medical device, not an algorithm, so this type of study is not applicable.

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

This information is not present. No specific ground truth for performance testing is mentioned. The ground for equivalence is based on the "long standing safety and effectiveness use of the concept" and comparison to legally marketed predicate devices.

8. The sample size for the training set

This information is not present. No training set is applicable as this is not a machine learning device.

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

This information is not present. No training set is applicable.

Summary of available information related to equivalence, not performance criteria:

The document demonstrates equivalence to predicate devices based on:

Intended Use: All predicate devices and the Trauma-Fix® External Fixator share the same intended uses for external fixation of long bone fractures, surgical osteotomy stabilization, leg lengthening, arthrodesis, and fixation of septic/aseptic non-unions, and pelvic fixation.
Operating Principles (Features):
- Distraction: Yes for all devices.
- Compression: Yes for all devices.
- Half Pins: Yes for all devices.
- Transfix Pins: Yes for all devices.
- Instruments: Yes for all devices.
- Performance Standards: All meet ASTM - ISO.
Materials: While there are differences (Trauma-Fix® uses Aluminum & Stainless; Zimmer uses Stainless steel; OrthoFrame uses Composite; Ace uses Al, Ti & Stainless), the document implies these differences do not raise new questions of safety or effectiveness.
Design: Trauma-Fix® offers both Uni-lateral & Quadrilateral designs, similar to the range offered by predicate devices (Zimmer: Quadrilateral; OrthoFrame: Uni-lateral; Ace: Uni-lateral & Multi-plane).
Sterilization: All use Steam sterilization, though the Trauma-Fix® is disposable while others are not. The document confirms validation of the recommended steam sterilization cycle for the Trauma-Fix®.

Conclusion from the document:

The FDA’s letter states: "We have reviewed your Section 510(k) notification... 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..." This is the "acceptance" that the device meets the regulatory requirements for market clearance based on substantial equivalence, not performance acceptance criteria from a specific study.

Summary

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JUN - 5 1997

K971272

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Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Trade Name:	Trauma-Fix® External Fixator
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External Fixator Common Name:

Single/multiple component metallic bone fixation appliances and Classification Name: accessories

3. Establishment Name & Registration Number:

Trend Medical, Inc. Name:

Number: Pending

4. Classification:

(a) Identification. Single/multiple component metallic bone fixation appliances and accessories. 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 titanjum, 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.

Unknown Product Code:

Class II Device Class:

Orthopaedic and Rehabilitation Devices Classification Panel:

Contact Person: 5.

Mr. Gordon Tao Trend Medical, Inc. 14433 Catalina Street San Leandro, CA 94577

6. Special Controls:

Special controls have not been established for this device.

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7. Description of the Device:

Background: The Trauma-Fix® External Fixator is offered as both a unilateral (uni-bar) and quadrilateral style (also called multi-plane) external fixation frame. External fixators known as unibar and multi-plane are typical of present industry standard designs. The uni-bar fixator concept is an outgrowth of the multi-plane fixator varying chiefly in the use of half-pins rather than the transfixing pins typical of multi-plane fixation, though occasionally half-pins are used with multi-plane fixators.

Unilateral frames using half plane fixators using half pins and transfixing pins were developed and popularized by Dr. Hoffmann near the turn of the century with the devices' seeing much use in Germany during the First World War. At the time the external fixation concept was not much appreciated in this country. Doctor Hoffmann used his device in the management of gun shot wounds involving significant tissue and bone loss of the extremities. In the era prior to antibiatic therapy, such injuries frequently led to sepsis, amputation or death if primary wound closure or casting alone were attempted. Limb salvage under these conditions required the ability to immobilize the bony and soft injury and to irrigate or debride the soft tissue injury daily for an extended period of time. Casting and wound closure could be eliminated or delayed as needed to manage infection, granulation healing and fracture healing. An added benefit was the fact that some weight bearing was possible and limb shortening could be reduced or eliminated.

Uni-bar fixation using half-pins for the treatment of various long bone fractures and trauma was an outgrowth of the multi-plane transfixing pin concept. The chief benefit of uni-bar fixat it is generally a less complex method of fracture fixation and open wound management than is treatment with the multi-plane fixator. As a result, the uni-bar technique is usually easier. The limitation of the uni-bar technique is that it provides less adjustment or significant rotational deformities or weight bearing. Also, when large axial compressive or distractive forces are encountered there can be a tendency for the axis of the long bone to the lack of bilateral or multi-plane support provided by the additional connection rods of a multi-plane fixator construct.

The functional basis for the Trauma-Fix® External Fixator line is to provide fixators that allow the practitioner the option to use the appropriate fixator for the presenting fracture injury type. Open wound orthopaedic management without significant weight bearing or high fracture site compression requirements may be addressed in a simple cost effective manner.

The Trauma-Fix® External Fixator line is made up of the following items:

Fixator

Pin Holder Clamps, 5 & 8 mm diameter Articulation Coupling, 5 & 8 mm diameter Connecting Rods, 5 & 8 mm diameter Adjustable Telescopic Connecting Rods, 5 & 8 mm diameter Small Lengthining Device for Forearm Colles Forearm Frame Half-Pins Full-Pins/Transfixing Pins KTB Wires Uni-Bar Pin Clamp Uni-Bar Smooth Rods Uni-Bar Compression & Distraction Rod Uni-Bar Connector

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Instruments

Drill Brace Chuck, 3, 4, 5, 6, mm T-Wrench Open Wrench Hex Screw Driver Drill Bit Trochar & Sleeve

In summary, uni-bar-type fixators offer simple design, ease of use and rapid stable fixation. Quadrilateral frames provide a more complex structure but also offer maximum flexibility and will allow for complex fracture reduction in all three planes, anterior, posterior and axial rotation. Both frame types are designed to be disposable and are not recommended for reuse.

8. Comparison to Predicate Device(s):

Four currently available external fixation devices have been selected for comparison.

OrthoFrame™ by Thera-Kinetics, Inc. Comparison based on design and indications for use. 1.
Hoffman-Type External Fixation by Zimmer, Inc. Comparison based on design, and 2. indications for use.
ACE-Fischer™ Fixator by DePuyACE. Comparison based on design, materials and indications ന് for use.
ACE-Align Fixator™ by DePuyACE. Comparison based on design, materials and indications for র্ব use.

The OrthoFrame™ is an example of a unilateral external fixator. This particular device is made from composite materials.

The Zimmer brand Hoffman-Type External Fixation is an example of an essentially unchanged Hoffmann-type external fixator. This device is essentially identical to Dr. Hoffmanns original devices. Made from certified stainless steel.

The ACE-Fischer™ Fixator is an example of a more modern design multi-plane fixator. The multiplane fixator is analogous to the quadrilateral multi-plane fixator. The device is made from titanium alloy (6AI, 4V, ti) and aluminum.

The ACE-Align Fixator™ is also an example of a unilateral fixator. This particular device is made from titanium alloy (6Al, 4V, ti) and aluminum.

9. Packaging:

Plastic bags, peel pouches, and clear tubes are used to contain the individual device components and or pins. The packaging selected for use is sufficient to identify, protect and transport the devices safely. Shipper materials are standard, paper fiber industry typical bulk box-type shipper packaging.

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10. Sterilization/Re-sterilization:

All fixation pins, instruments and external fixation compression and distraction components are supplied Non-Sterile. Non-Sterile implants are packaged in "clean only" condition but are free of manufacturing debris and residue. Each component is inspected after processing to evaluate and document the removal of manufacturing residue and debris. However, it is recommended that all pins, frames and clamps be removed from their shipping and packing materials and washed and rinsed thoroughly before storage and or sterilization.

The recommended sterilization method, time and temperature for the implants is gravity steam sterilization for 15 minutes at 134° C (270° F). The Sterility Assurance Level (SAL) of this recommended sterilization cycle is 10° (SAL 10°). Validation of the recommended cycle has been conducted by a qualified commercial laboratory. The validation method used is known as the overkill method. Other steam sterilization cycle time and temperature conditions may also render the device sterile.

The recommended sterilization method is based on Health Industry Manufacturers Association (HIMA) & the Association of Operating Room Nurses (AORN) protocols. Some health care facilities may wish to use other variations of the HIMA & AORN sterilization recommendations. However, individuals or hospitals not using the recommended method, temperature and time should validate any alternative sterility processing method using appropriate laboratory techniques.

12. Conclusion:

Based on the materials, intended uses, design, long standing safety and effectiveness use of the concept, the Uni-bar" External Fixator unit is equivalent to the referenced legally marketed comparison external fixation devices. The feature comparison chart below graphically demonstrates this equivalence.

FEATURE	Trauma-Fix®External Fixator	ZimmerHoffmann	OrthoFrame	Ace	SE?
Intended Use:	External fixation of longbone fractures. Externalfixation and stabilization ofsurgical osteotomy sites.Leg lengthening procedures.Knee, hip and anklearthrodesis. External fixationof septic and aseptic non-union of long bones Pelvicfixation	Same	Same	Same	Yes
Distraction	Yes	Yes	Yes	Yes	Yes
Compression:	Yes	Yes	Yes	Yes	Yes
Materials:	Aluminum & Stainless	Stainless steel	Composite	Al, Ti & Stainless	Yes
Design:	Uni-lateral &Quadrilateral	Quadrilateral	Uni-lateral	Uni-lateral &Multi-plane	Yes
Half Pins:	Yes	Yes	Yes	Yes	Yes
Transfix Pins:	Yes	Yes	Yes	Yes	Yes
Instruments:	Yes	Yes	Yes	Yes	Yes
Per. Standards:	ASTM - ISO	ASTM - ISO	ASTM - ISO	ASTM - ISO	Yes
Disposable:	Yes	No	No	No	No
Sterilization:	Steam	Steam	Steam	Steam	Yes
Manufacturer:	Trend Medical	Zimmer	Thera-Kenitics	DePuy/ACE	Yes

13. Comparison Table:

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 1997

Mr. David W. Schlerf Buckman Company, Inc. Representing Trend Medical, Inc. 1000 Burnett Avenue, Suite 450 Concord, California 94520

Re : K971272 Trauma-Fix® External Fixator Regulatory Class: II Product Code: KTW Dated: March 17, 1997 Received: April 4, 1997

Dear Mr. Schlerf :

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, 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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. David W. Schlerf

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 requlation (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,

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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K971272

510(k) Number (if known):

Device Name:

Indications For Use:

- 1. External fixation of long bone fractures.
  - 1. External fixation and stabilization of surgical osteotomy sites.
  - 1. Leg lengthening procedures.
  - 1. Knee, hip and ankle arthrodesis.
  - 1. External fixation of septic and aseptic non-union of long bones
  - 1. Pelvic fixation

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices/K971272
510(k) Number

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

exfix.doc

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.