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 carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.

AI/ML Overview

The provided text is a 510(k) Summary for the EBI® XFIX® DFS® System, an external fixation device. It outlines the device's description, intended use, materials, and comparison to predicate devices, focusing on demonstrating substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for a diagnostic AI/ML device.

The 510(k) process for this type of medical device (external fixation system) primarily relies on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, fundamental scientific technology, and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The "study" here is essentially the comparison and justification of equivalence to predicate devices, rather than a clinical performance study with defined metrics.

Therefore, many of the requested sections about acceptance criteria, performance metrics, ground truth, sample sizes for test/training sets, experts, and adjudication methods are not applicable to this type of submission.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance Study for EBI® XFIX® DFS® System

This 510(k) submission (K040935) seeks marketing clearance for a modified EBI® XFIX® DFS® System by demonstrating substantial equivalence to predicate devices. The "study" to meet this requirement is a comparison of the new device's characteristics to those of predicate devices, asserting that the modifications do not introduce new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical device submission demonstrating substantial equivalence, rather than a diagnostic AI/ML device, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics in the traditional sense. The "acceptance criteria" here implicitly revolve around demonstrating that the modified device's materials, intended use, and function are comparable to the predicate devices.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (as described in 510(k) Summary)
Intended Use: Same as predicate devices.	"The intended use and fundamental scientific technology have not changed from the previously cleared submission.""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."
Material: Same or equivalent engineering materials for intended function.	"This submission is only for the addition of carbon fiber material for the Straight Clamps, modification to the Carbon Ankle Clamp, and modification to the Carbon T-Clamp.""The components of the System may be manufactured from materials such as aluminum, stainless steel, titanium alloy, and carbon fiber.""The modified EBI XFIX DFS System is fabricated from the same materials as the components of the currently marketed EBI XFIX DFS Fixation System (implies similar materials, and specifically lists carbon fiber as an addition)."
Technological Characteristics/Functionality: Similar to predicate devices, with no significant differences impacting safety/effectiveness.	"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.""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."
Sterilization State: Consistent with predicate devices.	"The additional component of the EBI XFIX DFS System, like the components of the currently marketed EBI XFIX DFS System, is provided non-sterile."

2. Sample size used for the test set and the data provenance

Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. The "test" for substantial equivalence is a comparison of specifications and intended use against existing cleared devices.

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

Not applicable. Ground truth as typically understood for diagnostic performance studies is not relevant here. The ground truth for regulatory clearance in this context is the safety and effectiveness of the predicate devices.

4. Adjudication method for the test set

Not applicable. No test set for diagnostic performance.

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 an external fixation system, not a diagnostic imaging or AI algorithm that assists human readers.

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

Not applicable. This is a physical medical device (external fixation system), not an algorithm.

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use. The submission aims to establish that the modified device is equally safe and effective due to substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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040935
page 1 of 2

JUL - 6 2004

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 ParkwayParsippany, NJ 07054	Contact Person:	Frederic Testa
Telephone:	(973) 299-9300, x2208
Date prepared:	April 8, 2004

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) .
EBI® XFIX® DFS® System EBI, L.P. (K031919) .
OrthoFix XCaliber Fixation System .

4. Description of the device:

5. Intended Use:

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K040935
page 2 of 2

6. Materials:

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

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, K031919)

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 of substantial equivalence to any other product is intended only to relate 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 seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three curved lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

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

Re: K040935

Trade/Device Name: EBI® XFIX® DFS® System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, Regulatory Class: II

Product Codes: KTT Dated: April 8, 2004 Received: April 9, 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 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 - Frederic Testa, RAC

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), 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 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,

Miriam C. Provost

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® DF5® 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)

Prescription Use X(Per 21 CFR 801.109)	OR	Over-The-Counter Use
--------------------------------------------	----	----------------------

	Miriam C. Provost (Optional Format 1-2-96)
(Division Sign-Off)
	Division of General, Restorative,and Neurological Devices

510(k) Number	K640935
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510(k) Number

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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.