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 components to the existing System. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

AI/ML Overview

Here's an analysis of the provided text regarding the EBI® XFIX® Vision™ Fixation System, focusing on acceptance criteria and supporting studies.

Based on the provided document, there is NO information regarding acceptance criteria or a study proving the device meets them.

This 510(k) submission (K011711) is a Special 510(k) Device Modification for the EBI® XFIX® Vision® Fixation System. This type of submission is used when changes are made to a previously cleared device that do not affect its fundamental scientific technology or intended use. The primary purpose of such a submission is to demonstrate that the modified device remains substantially equivalent to the predicate device.

Therefore, the document focuses on comparing the modified device to its predicate (EBI® XFIX® Vision® Fixation System K993886) in terms of materials, intended use, and function, rather than establishing new performance criteria or presenting a new clinical study.

Here's a breakdown of why the requested information is absent:

A table of acceptance criteria and the reported device performance: Not present. The document asserts substantial equivalence, meaning it relies on the predicate device's established performance without defining new criteria for the modified components.
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 clinical study for this modification is reported.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a mechanical fixation device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does state and imply is relevant to its intended purpose:

Predicate Device: EBI® XFIX® Vision® Fixation System (K993886)
Key Argument for Substantial Equivalence:
- Same materials (e.g., stainless steel, titanium alloy).
- Same intended use (treatment of bone conditions like leg lengthening, osteotomies, arthrodesis, fracture fixation).
- Similar design elements (bone screw clamps designed for attachment to bone screws).
- Same non-sterile provision.
Conclusion by FDA: The FDA determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information provided in the 510(k) notification, which emphasizes the lack of significant differences from the previously cleared predicate.

In summary, this document is a regulatory filing focused on demonstrating substantial equivalence for a device modification, not on presenting novel performance data or acceptance criteria for a new device.

Summary

{0}------------------------------------------------

11711 Special 510(k) Device Modification: EBI® XFIX® Vision™ Fixation System

6/29/01

510(k) Summary of Safety and Effectiveness

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

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

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

June 1, 2001 Date Prepared:

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)

4. Description of Device:

5. Intended Use:

{1}------------------------------------------------

6. Materials:

The components of the System may be manufactured from materials such as The components of the System may be manager, 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)

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® YFIX® 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 " Ally statement made in confinent and servilly marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infingement litigation. [Establishment Registration and Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2001

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

Re: K011711

Trade Name: Modification to EBI® EFIX® Vision Fixation System Regulatory Number: 888.3030 Regulatory Class: II Product Code: KTT Dated: June 1, 2001 Received: June 4, 2001

Dear Ms. Flood:

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 control provisions of the Act. The general control 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 regulations 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 current Good Manufacturing Practice requirement, 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 comply with the GMP 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.

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.

{3}------------------------------------------------

Page 2 - Ms. Patricia Flood

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for invitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (201) 594-4639. Addinesian) (201) 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Dmitchell runs

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

ದಿ

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

11711 510(k) Number (if known): C EBI® XFIX® Vision® Fixation 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)

ర్ర

Page

Mitchell Ref for cuuu

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

510(k) Number K010711

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.