The EBI® XFIX® Vision® Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The System consists of external fixation components and implantable bone screws. The EBI® XFIX® Vision® Fixation System is utilized in the following manner: bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI® XFIX® Vision® Fixation System is attached to the shanks of the bone screws. This submission is for the addition of "adapters" to the existing System, which allow connection to various EBI® XFIX® System Fixators. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

AI/ML Overview

The provided text is a 510(k) summary for a medical device modification, specifically the EBI® XFIX® Vision® Fixation System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the safety and effectiveness of a novel device through clinical performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's why the requested information is absent and what the document does provide:

Acceptance Criteria and Reported Device Performance: Not applicable for a 510(k) modification where substantial equivalence is claimed. The submission focuses on comparing the modified device's characteristics to a predicate device.
Sample sizes for test set and data provenance: No test sets or clinical performance data are presented.
Number of experts used to establish ground truth & qualifications: No ground truth establishment occurred as no performance study was conducted.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not present. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k).
Standalone (algorithm only) performance: Not applicable as this is a mechanical fixation system, not an algorithm.
Type of ground truth used: Not applicable as no performance study was conducted.
Sample size for the training set: Not applicable as there is no algorithm or machine learning model in this device.
How the ground truth for the training set was established: Not applicable.

What the document does discuss:

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence between a modified EBI® XFIX® Vision® Fixation System and its predicate devices (K993886, K011711). The modification involves the addition of "adapters" to the existing system.

The comparison focuses on:

Materials: Stating that the additional components are fabricated from the same materials as the currently marketed system (Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy).
Intended Use: Confirming that the modified device has the same indications for use as the predicate: "treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality."
Function/Design: Highlighting that the bone screw clamps of the modified system are designed for attachment to the bone screws, similar to the currently marketed system.
Sterility: Both are provided non-sterile.

The conclusion is that "There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent to the predicate device with regard to intended use, materials, and function."

Summary

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FEB 0 5 2002

Special 510(k) Device Modification: EBI® XFIX® Vision® Fixation System

510(k) Summary

020141

This 510(k) Summary for the EBI® XFIX® Vision® Fixation System is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.

1. Sponsor: Contact Person: Patricia Flood, RAC EBI, L.P. Telephone: (973) 299-9300, ext.3318 100 Interpace Parkway Parsippany, NJ 07054
  Date Prepared: January 15, 2002

2. Proprietary Name:	EBI® XFIX® Vision® Fixation System
Common Name:	External Fixation Device
Classification Name:	Single Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030.

3. Predicate or Legally Marketed Device:

EBI® XFIX® Vision® Fixation System (K993886, K011711) ●

4. Description of Device:

5. Intended Use:

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6. Materials:

The components of the System may be manufactured from materials such as Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy.

7. Comparison of the technological characteristics of the device to predicate devices:

The modified EBI® XFIX® Vision® Fixation System is substantially equivalent to the following predicate device:

EBI® XFIX® Vision® Fixation System (K993886, K011711)

The additional EBI® XFIX® Vision® Fixation System components are . fabricated from the same materials as the components of the currently marketed EBI® XFIX® Vision® Fixation System.
The modified EBI XFIX® Vision® Fixation System and the currently . marketed EBI® XFIX® Vision® Fixation System are both indicated for the treatment of bone conditions, including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
The bone screw clamps of the modified EBI® XFIX® Vision® Fixation . System, like the bone screw clamps currently marketed in the EBI® XFIX® Vision® Fixation System, are designed for attachment to the bone screws.
The modified EBI® XFIX® Vision® Fixation System like the currently ● marketed EBI® XFIX® Vision® Fixation System, is provided non-sterile.

There are no significant differences between the modified EBI® XFIX® Vision® Fixation System and the currently marketed EBI® XFIX® Vision® Fixation System. It is substantially equivalent* to the predicate device with regard to intended use, materials, and function.

* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K020141 Trade/Device Name: EBI EFIX Vision Fixation System Regulatory Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: January 15, 2002 Received: January 16, 2002

Dear Mr. Caparotta:

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 - Mr. Jon Caparotta

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally premarket notification. The Pro Print and ssification 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 additionally 21 OF IC For Car (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 091-1009 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 Oiner general mistmational 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 vours,

Sincerely yours,

Q. Mark N. Millenn

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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STATEMENT OF INDICATIONS FOR USE

Page 1 of 1 -

62014 510(k) Number (if known):

Device Name: EBI® XFIX® Vision® 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)

Over-The-Counter Use (Optional Format 1-2-96)

Mark N Millikin

of General, Restorative and Neurological Devices

510(k) Number K020141

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.