The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction 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 Rail 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 Rail System is attached to the shanks of the bone screws. This submission is for the addition of a carbon fiber (radiolucent) Rail to the System.

AI/ML Overview

This document is a 510(k) Premarket Notification for the EBI XFIX DFS Rail System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily for the addition of a carbon fiber (radiolucent) Rail. This type of submission, for a physical medical device, does not typically involve the kinds of studies and data points (like AI performance metrics, expert ground truth, training/test set sizes) that would be relevant for an AI/ML-based device.

Therefore, many of the requested details about acceptance criteria for AI performance, study methodology, expert consensus, and data provenance are not applicable to this 510(k) submission.

Here's a breakdown of what can be extracted from the provided text, aligning with the request where possible, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for AI Performance)	Reported Device Performance (as demonstrated for substantial equivalence)
Substantial Equivalence to Predicate Devices:	- Indicated for the same bone conditions (limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute/gradual multiplanar correction, etc.).
- Intended Use	- Provided non-sterile.
- Sterility/Provision	- Fabricated from the same materials (titanium alloy, stainless steel, aluminum, carbon fiber reinforced epoxy, Pyromet® 718).
- Materials	- No significant differences in function or mechanical integrity compared to the predicate EBI XFIX DFS Rail System (K991941, K000083, K010437) and EBI XFIX Vision Fixation System (K993886, K014194, K020141).
- Function and Mechanical Integrity

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

Not Applicable. This submission is for a physical medical device (an external fixation system), not an AI/ML diagnostic device that would typically have test sets of data. The "testing" referred to for this device would be mechanical and material testing to ensure structural integrity and biocompatibility, not performance evaluation against a dataset for diagnostic accuracy.

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

Not Applicable. As this is not an AI/ML diagnostic device, there is no "ground truth" establishment in the context of expert consensus on image interpretation or similar. The "experts" involved would be engineers and material scientists for device design and testing, and potentially orthopedic surgeons for clinical input on device use.

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

Not Applicable. No test set adjudication method for AI performance is relevant to this device.

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. MRMC studies are used for evaluating diagnostic performance with AI assistance. This device is not an AI diagnostic tool and does not involve human "readers" or AI assistance in that context.

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

Not Applicable. This is not an algorithm.

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

Not Applicable. For this device, "ground truth" would relate to accepted engineering standards for device strength, material properties, and biocompatibility, as well as established clinical efficacy for external fixation devices. It's not typically a "ground truth" in the diagnostic data sense.

8. The sample size for the training set:

Not Applicable. This device does not use an AI training set.

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

Not Applicable. This device does not use an AI training set, so no ground truth for it was established.

Summary of What This Document Does Provide:

The provided 510(k) summary explicitly states that the submission is for the "addition of a carbon fiber (radiolucent) Rail to the System." The core of the justification for market clearance (substantial equivalence) relies on:

Identical Intended Use: The proposed device and predicate devices are used for the same general orthopedic conditions requiring external fixation.
Similar Materials: The new component uses carbon fiber, which is explicitly listed as a material that can be used in the system, alongside other materials common to the predicate devices.
Comparable Function and Mechanical Integrity: The submission asserts that there are "no significant differences" in these aspects, implying that mechanical testing (which is standard for all medical devices but not detailed here) would have been performed to support this claim.
Non-sterile Provision: Both the proposed and predicate devices are provided non-sterile, indicating a consistent approach to sterilization (likely by the end-user or facility).

The FDA's letter (K021031) confirms that a substantial equivalence determination was made based on these comparisons to predicate devices.

Summary

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Traditional 510(k) Premarket Notification EBI® XFIX® DFS® Rail System

510(k) Summary

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

1. Sponsor:	Contact Person:
EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Patricia Flood, RAC
	Telephone: (973) 299-9300, ext.3318
Date Prepared:	March 28, 2002
2. Proprietary Name:	EBI XFIX DFS Rail 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 Devices:

EBI XFIX DFS Rail System (K991941, K000083, K010437) .
EBI XFIX Vision Fixation System (K993886, K014194, K020141) .

4. Description of Device:

5. Intended Use:

The EBI XFIX DFS Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction, and other bone conditions amenable to treatment by use of the external fixation modality.

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K021031

6. Materials:

The components of the System may be manufactured from materials such as titanium alloy, stainless steel, aluminum, carbon fiber reinforced epoxy, and Pyromet® 718.

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

The proposed EBI XFIX DFS Rail System is substantially equivalent to the following predicate EBI devices:

EBI XFIX DFS Rail System (K991941, K000083, K010437) EBI XFIX Vision Fixation System (K993886, K014194, K020141)

The proposed EBI XFIX DFS Rail System and the currently marketed EBI . XFIX DFS Rail System are both indicated for the treatment of bone conditions, including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.
The proposed EBI XFIX DFS Rail System, like the currently marketed ● EBI XFIX DFS Rail System and the EBI XFIX Vision Fixation System, is provided non-sterile.
The components of the proposed EBI XFIX DFS Rail System are . fabricated from the same materials as the components of the currently marketed EBI XFIX DFS Rail System and the EBI XFIX Vision Fixation System.
There are no significant differences between the proposed EBI XFIX DFS . Rail System and the currently marketed EBI XFIX DFS Rail System. It is substantially equivalent* to the predicate device with regard to intended use, materials, function, and mechanical integrity.

* 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 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract, curved shapes stacked on top of each other, possibly representing human figures or a stylized eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2002

Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K021031

Trade/Device Name: EBI® XFIX® DFS® Rail System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 28, 2002 Received: March 29, 2002

Dear Mr. Caparotta:

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 - Mr. Jon Caparotta

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,

iriam C. Provost

for 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

510(k) Number (if known): K02103 |

Device Name: EBI® XFIX® DFS® Rail 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 X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Miriam C. Provost

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

510(k) Number K 02103/

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.