The EBI® XFIX® DFS® System is 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 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 Gradual Swivel Clamp to the System.

AI/ML Overview

This submission is for a modification to an existing external fixation system, not a device that relies on AI or complex algorithms for performance. Therefore, the provided text does not contain any information about acceptance criteria or a study proving a device meets those criteria in the context of AI/algorithm performance.

The document is a 510(k) summary for a medical device (EBI® XFIX® DFS® System) that discusses:

Sponsor and Contact Information
Proprietary and Common Names
Classification
Predicate Device: EBI® XFIX® DFS® System (K953406)
Device Description: The system consists of external fixation components and implantable bone screws. The submission is only for the addition of a Gradual Swivel Clamp.
Intended Use: Treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by external fixation.
Materials: Aluminum, stainless steel, and titanium alloy.
Comparison to Predicate: The modified device is stated to be "substantially equivalent" to the predicate device in terms of materials, intended use, and function, with no significant differences. The added component (Gradual Swivel Clamp) is also non-sterile, like other components.
FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

To directly answer your specific questions based on the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. This document is for a mechanical device modification, not a performance-based algorithm or AI system. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence to a predicate device, which is stated as having been met.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no mention of a test set, data, or a clinical study for performance evaluation in the context of an algorithm. The assessment is based on mechanical and material equivalence.
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 experts were used for ground truth establishment for a test set as described in the context of AI/algorithm evaluation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no test set or adjudication for an algorithm.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's equivalence is being assessed.
The sample size for the training set: Not applicable. There is no training set mentioned for an algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a minor modification to an existing mechanical external fixation system. It relies on a demonstration of "substantial equivalence" to a predicate device rather than performance criteria derived from a study involving algorithms, data, or expert evaluation as you've outlined in your questions.

Summary

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OCT 1 8 2002

K023324
page 1 of 2

510(k) Summary

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

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

September 30, 2002 Date prepared:

2. Proprietary Name:	EBI® XFIX® DFS® System
Common Name:	External Fixation Device
Classification Names:	Single/Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR888.3030

3. Predicate or Legally Marketed Device:

EBI® XFIX® DFS® System EBI, L.P. (K953406) .

4. Description of the device:

5. Intended Use:

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K023324
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6. Materials:

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

1. 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 intended to be 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 shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection. The overall design is simple and monochromatic, conveying a sense of official authority and purpose.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2002

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

Re: K023324

Trade/Device Name: Modification to EBI® XFIX® DFS® System Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: October 3, 2002 Received: October 4, 2002

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. Iisting 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. Frederic Testa

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" (21 CFR 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 yours,

O Mark W. Wilkerson

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® DFS® System

Indications For 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109 (Optional Format 1-2-96) Nes al, Restorative and Neurological Devic 510(k) Number_

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.