Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.

Device Description

CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring). Part of external fixator aiding trophism in the correction of bone deformities/defects. Same physical design as predicate, except aesthetically and tactual more pleasing with improved impression of superior strength and safe mobility. Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%.

AI/ML Overview

The CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) was evaluated against its predicate device, the Ilizarov External Fixation System (K962808). The study focused on demonstrating comparative performance rather than setting specific acceptance criteria for absolute performance.

Here's a breakdown of the information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document describes a comparative study, implying that the "acceptance criteria" were met by demonstrating superiority in certain mechanical tests compared to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (CyberOrthology CIRfix)
Mechanical Performance Equal or Superior to Predicate Device	15%-20% superiority compared to the predicate device in comparative testing. Specific tests mentioned include: Compression Stiffness (ASTM F-1746), 3-Point Bending, Cantilever Bending, and Wire Pull-out Test.
Similar Indication for Use	Same as the predicate device: Part of external fixator aiding trophism in the correction of bone deformities/defects.
Similar Target Population	Same as the predicate device: Human of any gender and at the advanced walking age.
Material Properties	Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%. (Predicate features pre-determined fiber orientations and typically 55% carbon fiber content).
Sterility	Shipped non-sterile & device may be sterilized as required by any method. (Same as predicate).
Biocompatibility	Component is a non-invasive external device, not for implantation or contact with skin/soft tissues. (Same as predicate).
Mechanical Safety	Test procedures and requirements allow for appropriate rigidity and stability. (Same as predicate).
Chemical Safety	Indicated for use in clinical and common patient living environments, not exposed to harmful chemical elements. (Same as predicate).
Compatibility with other Devices	Compatible with all appropriate predicate devices. (Predicate compatible with specially designed frames, clamps, rods, couplings, pins, posts, bolts, washers, nuts, & others).

2. Sample Size and Data Provenance

The document does not specify the precise sample size used for the comparative mechanical tests. It only states "Comparatively tested." The data provenance is not mentioned (e.g., country of origin) nor whether it was retrospective or prospective, but given it's a mechanical performance comparison, it would likely be laboratory-based testing.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the study described is a mechanical performance comparison of a medical device, not a study involving human interpretation of data where expert ground truth would be established (e.g., in medical image analysis).

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. MRMC Comparative Effectiveness Study

An MRMC (Multi Reader Multi Case) comparative effectiveness study was not conducted. The study described is a direct mechanical comparison of a new physical device against an existing physical device, not an evaluation of human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone performance study in the context of patient outcomes or clinical efficacy was not explicitly described for the CyberOrthology CIRfix. The "performance" described is a standalone mechanical performance comparison against a predicate device in a laboratory setting. The document highlights mechanical superiority of the new device (15-20% superiority in various tests) when compared to the predicate device.

7. Type of Ground Truth Used

The "ground truth" for this study was established through mechanical testing standards (e.g., ASTM F-1746 for Compression Stiffness) and direct comparison of measurable physical properties against a predicate device. This is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense.

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

This information is not applicable for the reasons stated above.

Summary

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SEP 2 2 2003

510(K) SUMMARY (as required by 807.92(c))

032169
page 1 of 3

Submitter of 510(k):	Cyber Orthology, Inc.6301 Hughes Dr.Sterling Heights, MI 48312Phone: 586-264-9544Fax: 586-264-9566
Contact Person:	Dr. Djoldas Kuldjanov
Date of Summary:	June 30, 2003
Trade Name:	CyberOrthology Carbon Fiber Composite Circular Fixation(CIRfix) Device (Half Ring)
Classification Name:	APPLIANCE, FIXATION, NAIL/BLADE/PLATECOMBINATION, MULTIPLE COMPONENT
Classification Product Code:	KTT
Predicate Device:	Ilizarov External Fixation System	K962808
	External Fixation System	K870961
Intended Use:

Conclusion:

This device has equivalent intended use, has similar promotional claims, conforms to similar standards, and has equivalent technological characteristics to predicate devices.

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Device Comparison Chart

Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K032169", and the text below reads "page 2 of 3". The handwriting is in black ink and appears to be cursive.

Comparison Items	CyberOrthology CarbonFiber Composite CircularFixation (CIRfix) device	Ilizarov External FixationSystem K962808
Indication for Use	Part of external fixator aidingtrophism in the correction ofbone deformities/defects.	Same
Target population	Human of any gender and atthe advanced walking age	Same
Design	Same physical design, exceptaesthetically and tactual morepleasing with improvedimpression of superiorstrength and safe mobility	Circular half-ring withoverlapping ends to form aperfect ring whenjoined together by bolts andnuts
Material	Radiolucent Carbon FiberComposite utilizingRandomly orientated, pre-impregnated carbonstrands resulting in acarbon fiber content ofbetter than 62%.	Radiolucent Carbon FiberComposite featuringpre-determined fiberorientations and typically 55%carbon fiber content.
Performance	Comparatively tested,indicating 15%-20%superiority.	Compression Stiffness,(ASTM F-1746). 3-PointBending. Cantilever Bending.Wire Pull-out Test.
Sterility	Shipped none-sterile & devicemay be sterilized as requiredby any method.	Same
Biocompatibility	The component is a noneinvasive external device andwill not be used forimplantation or contact withskin or soft tissues.	Same
Mechanical Safety	The test procedure&requirements allow for theappropriate amount of rigidityand stability.	Same
Chemical Safety	The device is indicated for usein clinical and common patientliving environment not beingexposed toharmful chemical elements	Same
Compatibility with otherDevices	Compatible with allappropriate predicate devices	Compatible with speciallydesigned frames, clamps, rods,couplings, pins, posts, bolts,washers, nuts, & others for themanagement of appropriateorthopedic surgeries

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Device Comparison Chart

Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The top line reads 'K032169', with the 'k' being lowercase and the other characters being numbers. The second line reads 'page 3 of 3', indicating that this is the third page of a three-page document.

Where used	The device is being used in hospitals and in patients surroundings and environments
	Same

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Image /page/3/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized lines that resemble a bird in flight. The lines are thick and curved, and they are arranged in a way that suggests movement.

Public Health Service

SEP 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CyberOrthology, Inc. c/o Mr. Arthur Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K032169

Trade/Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 30, 2003 Received: July 21, 2003

Dear Mr. Ward:

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. Lisa M. Boyle

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.

Mark M. Wilkerson

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):

Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkman

(Division of General, Restorative and Neurological I

Number K032169

510(k) Number -

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

(Optional Format 1-2-96)

Regulation Number and Section

N/A