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

AI/ML Overview

This is a 510(k) Premarket Notification for a medical device modification, not an AI/ML device. Therefore, the request for information on acceptance criteria and study details related to device performance in the context of an AI/ML system (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

The document describes a "Special 510(k) Device Modification" for the EBI® XFIX® Vision® Fixation System. This type of submission is typically for minor changes to an already legally marketed device where the modifications do not significantly alter the fundamental scientific technology or intended use.

Here's a breakdown of what the document does provide, structured to address relevant parts of your query, while explicitly stating where AI/ML-specific details are not present:

Acceptance Criteria and Study for K040833: EBI® XFIX® Vision® Fixation System

This submission is for a modification (additional rod sizes) to an existing external fixation system. The primary "acceptance criteria" and "study" for this type of submission revolve around demonstrating substantial equivalence to the predicate device, particularly regarding the modified components not raising new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

For a device modification of this nature, the "acceptance criteria" are implicitly met by demonstrating that the new components (additional rod sizes) do not change the fundamental characteristics, materials, or intended use compared to the predicate device. The "reported device performance" is a demonstration of this equivalency.

Acceptance Criterion (Implicit for device modification)	Reported Device Performance (as per submission)
Materials: Modified components fabricated from the same materials as predicate.	The additional EBI® XFIX® Vision® Fixation System components are fabricated from the same materials (Aluminum Alloy, Stainless Steel, Pyromet® 718, Carbon Fiber, and Titanium Alloy) as the components of the currently marketed EBI® XFIX® Vision® Fixation System. (Page 2)
Intended Use: Modified device maintains the same intended use as predicate.	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 intended use has not changed. (Page 1 & 2)
Function/Design: Modified components function similarly to predicate components.	The bone screw clamps of the modified EBI® XFIX® Vision® Fixation System, like the bone screw clamps currently marketed, are designed for attachment to the bone screws. There are no significant differences between the modified system and the currently marketed system regarding function. (Page 2)
Sterilization: Modified device sterilization status is consistent with predicate.	The modified EBI® XFIX® Vision® Fixation System, like the currently marketed EBI® XFIX® Vision® Fixation System, is provided non-sterile. (Page 2)
Overall Substantial Equivalence: No significant differences in technological characteristics.	"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." (Page 2) FDA Conclusion: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (Page 3)

The following points (2-9) are typically relevant for AI/ML device submissions, but are NOT applicable to this 510(k) for a physical medical device modification. This document does not describe an AI/ML algorithm or its evaluation.

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. This is a physical device modification, not an AI/ML algorithm requiring a dataset for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this submission.

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

Not Applicable. No test set or adjudication process relevant to AI/ML performance 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 is not an AI-assisted diagnostic or therapeutic device.

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

Not Applicable. No algorithm is present.

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

Not Applicable. No ground truth for an AI/ML task is relevant here.

8. The sample size for the training set:

Not Applicable. No training set for an AI/ML algorithm is relevant here.

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

Not Applicable. No training set or ground truth establishment for an AI/ML algorithm is relevant here.

Summary

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K040833
page 1 of 2

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

510(k) Summary

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.

Contact Person: Frederic Testa, RAC 1. Sponsor: (973) 299-9300, ext.2208 Telephone: EBI. L.P. 100 Interpace Parkway Parsippany, NJ 07054

Date Prepared: March 23, 2004

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, K014194, ♥ K033635)

4. Description of Device:

5. Intended Use:

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040833
page 2 of 2

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, K014194, K033635)

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.

* pry 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 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2004

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

Re: K040833 Trade/Device Name: EBI® XFIX® Vision® Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 23, 2004 Received: March 31, 2004

Dear Mr. Testa:

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 complics 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. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device 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 other general mixtimational 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,

Martin A Mulheran

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

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 A. Melkeum

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

510(k) Number

K040833

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.