The EBI® XFIX® DFS® 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 fixation components and implantable bone screws. The bone screws are inserted through the patient's skin and soft tissue, and into the bone. The fixator frame of the EBI XFIX® DFS® System is attached to the shanks of the bone screws. This submission is for the availability of a Central Body Variable Clamp.

AI/ML Overview

This submission is a 510(k) premarket notification for a medical device, the EBI® XFIX® DFS® System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness. Therefore, the information typically gathered from such studies (like detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) is not present in this document for the new device.

The document focuses on comparing the new device to a predicate device (EBI® XFIX® DFS® System, K953406) based on materials, intended use, and function.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" for the new device are typically met by demonstrating that it is substantially equivalent to a predicate device that has already met its own safety and effectiveness criteria. The document explicitly states:

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

Therefore, the performance of the new device is assumed to be equivalent to the predicate, and no new performance data or specific acceptance criteria are presented for it.

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

This information is not applicable and not provided. This 510(k) submission is not based on a clinical study of the new device that would involve a test set. It relies on a comparison to an existing predicate device.

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

This information is not applicable and not provided. As no new clinical study was conducted for this 510(k) anlaysis, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This 510(k) submission is for an external fixation system, not a device typically evaluated with MRMC studies (which are common for imaging and diagnostic AI).

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

No, a standalone study was not done. This device is a mechanical external fixation system and does not involve algorithms or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable and not provided for the new device. The "ground truth" for a 510(k) submission of this type is essentially the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

Summary of Device and 510(k) approach:

The EBI® XFIX® DFS® System is an external fixation device. This 510(k) submission (K013739) is for a modification to an existing, legally marketed device (K953406) by introducing a "Central Body Variable Clamp."

The basis for regulatory clearance (510(k)) is by demonstrating "substantial equivalence" to the predicate device, not by conducting new clinical trials for safety and effectiveness that would generate performance data against specific acceptance criteria. The submission explicitly states equivalence in "intended use, materials, and function."

Therefore, the document does not contain the detailed study information you've requested as would be found in a submission requiring de novo clearance or a premarket approval (PMA) based on extensive clinical data.

Summary

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013739
page 1 of 2

DEC 1 3 2001

510(k) Summary

This 510(k) summary for the EBI® XFIX® DFS® System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

Sponsor: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Contact Person: Frederic Testa (973) 299-9300, ext.2208 Telephone:

Date Prepared: November 12, 2001

2. Proprietary Name:	EBI® XFIX® DFS® 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 Devices:

EBI® XFIX® DFS® System (K953406) ●

4. Description of Device:

The system consists of fixation components and implantable bone screws. The EBI® The system consists of inculibed 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 EBIT XFIX® DFS® System is attached to the shanks of the bone screws. This submission is for the availability of a Central Body Variable Clamp.

Intended Use: 5.

The EBI® XFIX® DFS® System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, corrective use in the ucation of bone fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

6. Materials:

The components of the System may be manufactured from materials such as titanium alloy, stainless steel, aluminum, and carbon fiber.

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KC13739
Page 2 of 2

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

devices:

The modified EBI XFIX DFS System is fabricated from the same . The mounted as the components of the currently marketed EBI XFIX DFS System.
The modified EBI XFIX DFS System and the currently marketed EBI . XFIX DFS 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 DFS System, like ● the bone screw clamps currently marketed in the EBI XFIX DFS System, are designed for attachment to the bone screws.
The additional component of the EBI XFIX DFS System, like the . The addination of the currently marketed EBI XFIX DFS System, is provided non-sterile.
There are no significant differences between the proposed EBI® . There are no significant and the currently marketed EBI® XFIX® DFS® 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 substantial equivalence to any other * Any statement made in conjunction will this submission regions of evidence in patch in the market approval or product is intended only to relate to be an amission of evidence in patent in patent infringencer reclassification and is not interpreted & an annussion of ally cation of the Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending from the body, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Testa Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

DEC 1 3 2001

Re: K013739 Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: November 12, 2001 Received: November 13, 2001

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we nave reviewed your becaon 310(x) premiented is substantially equivalent (for the indications felerenced above and nave december and are and and and one marketed in interstate for use stated in the enclosure) to regarly annual date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug, devices that have been i cclassified in accessfired in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, books of the more in the manual registration, listing of general controls provisions of the rice 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 If your device is classified (soc above) ans. Existing major regulations affecting your device can may be subject to such additions, 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 r lease be advised that 1 Dr. 3 rosaultes complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I coclar statutes and registeriances, including, but not limited to: registration and listing (21 Comply with an the Fet 8 requirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN Fatt 807), adomig (21 OF R Part 820), and if applicable, the electronic forth in the quality by tions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,

Sincerely, yours,

Mark McMillan

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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Page / of /

510(k) Number (if known): KO/ 3739

Device Name: EBI® XFIX® DFS®System

Indications For Use:

Mark N Milberson

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Kol 3739 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.