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 EBI® XFIX® DFS® 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® DFS® System is attached to the shanks of the bone screws. The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a component to the System.

AI/ML Overview

The provided text describes a 510(k) submission for a device modification of the EBI® XFIX® DFS® Fixation System. It explicitly states that "The intended use and fundamental scientific technology have not changed from the previously cleared submission. This submission is only for the addition of a component to the System." This type of submission, a Special 510(k), focuses on demonstrating that the modified device remains substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness.

Therefore, the submission does not contain a new study that establishes acceptance criteria and proves the device meets them from scratch. Instead, it relies on the predicate device's existing clearance and demonstrates that the modification does not alter the fundamental performance or safety profile.

Based on the provided text, I cannot fill out the requested table or answer most of the questions as a new study with explicit acceptance criteria and performance data is not presented or required for this type of 510(k) modification.

However, I can provide information based on what is stated:

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

Not applicable. This 510(k) is for a device modification and asserts substantial equivalence to a predicate device (EBI® XFIX® DFS® System K953406). No new acceptance criteria or performance data for the modified device are presented. The key "performance" reported is its substantial equivalence to the predicate.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (K953406) in terms of:	The modified EBI® XFIX® DFS® System is substantially equivalent to the predicate device.
- Intended Use	Same intended use: 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.
- Materials	Fabricated from the same materials (Aluminum, Stainless Steel, Cobalt Chrome, Carbon Fiber, and Titanium Alloy) as the predicate.
- Function	Functions in the same manner; the additional component still attaches to bone screws, and the system design has no significant differences that would alter performance.

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

Not applicable. No new test set or clinical study data is presented for this modification. The documentation focuses on engineering and material comparisons to establish substantial equivalence.

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):

Not applicable. No new ground truth establishment process is described. The basis for safety and effectiveness relies on the predicate device's clearance.

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

Not applicable. No new test set requiring adjudication 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:

Not applicable. This device is a mechanical external fixation system. It is not an AI-powered diagnostic or therapeutic device, and therefore MRMC studies are not relevant.

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

Not applicable. This device is a mechanical external fixation system, not an algorithm.

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

Not applicable. For this specific 510(k) modification, "ground truth" is primarily based on the demonstrated safety and effectiveness of the predicate device (EBI® XFIX® DFS® System K953406) through its prior clearance, and the engineering assessment that the modification does not introduce new safety or effectiveness concerns.

8. The sample size for the training set:

Not applicable. This device is a mechanical external fixation system and does not involve AI/machine learning requiring a training set.

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

Not applicable. This device is a mechanical external fixation system and does not involve AI/machine learning.

Summary

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K012024

JUL 2 5 2001

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

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® DFS® System is This Jro(k) Baniinary of Section 513(I)(3) of the Federal Food, Drug and Cosmetic Act.

1. Sponsor:

Contact Person: Patricia Flood, RAC (973) 299-9300, ext.3318 Telephone:

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

Date Prepared: June 27, 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 Device:

EBI® XFIX® DFS® System (K953406) .

4. Description of Device:

5. Intended Use:

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.

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6. Materials:

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

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

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

EBI® XFIX® DFS® System (K953406)

The modified EBI® XFIX® DFS® System is fabricated from . the same materials as the components of the currently marketed EBI® XFIX® DFS® Fixation 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 . components of the currently marketed EBI® XFIX® DFS® System, is provided non-sterile.
There are no significant differences between the modified 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.

* 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three abstract human profiles facing right, with flowing lines extending from the bottom profile. The overall design is simple and conveys a sense of unity and service.

JUL 2 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K012024

Trade/Device Name: EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulatory Class: II Product Code: KTT Dated: June 27, 2001 Received: June28, 2001

Dear Ms. Flood:

We have reviewed your Section 510(k) notification of intent to market the device referenced w one reveal your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the energials, to regard ent date of the Medical Device Amendments, or to devices that prior to rial) 20, 1976, 1976, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costilons of the Act. The general controls provisions of the Act include requirements for annual provisions of the Pres. "Proces, 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 regulations ( Femanel I pprovide can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moportunity also 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 - Ms. Patricia Flood, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to begin markening , one device to a legally marketed nouncation. The I Dri Imaling of succion 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 IT you desire specific advice for your actic devices), please contact the Office of Compliance at additionally 807.10 for m True diagnessions on the promotion and advertising of your device, (301) 594-4037. Addinomary, 101 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Misoranuming of Felection to president from the Division of Small mountation on your responsibility and 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,

Rtmhllulm fa

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

of of Page -

510(k) Number (if known):

EBI® XFIX® DFS® System Device Name:

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 (Optional Format 1-2-96)

KmnheeeMD

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative
Productrological Devices (Division of General, Teneral, Tel. Division of Neurological Division of Neurological (2 and Neurological Development

510(k) Numbe

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.