The EBI® XFIX® DFS® OptiROM® Elbow Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

Fracture dislocation with ligamentos instability.
Comminuted intra-articular fractures.
Post traumatic reconstruction for joint stiffness.

Device Description

The System consists of external fixation components and implantable bone screws. The EBI XFIX DFS OptiROM Elbow Fixator 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 OptiROM Elbow Fixator is attached to the shanks of the bone screws. This submission is for the addition of a carbon fiber ulnar bar, as well as components to allow for posterior bone screw placement in the humerus. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

AI/ML Overview

This document pertains to a 510(k) submission for a device modification of the EBI® XFIX® DFS® OptiROM® Elbow Fixator. The submission focuses on the addition of specific components (carbon fiber ulnar bar and components for posterior bone screw placement in the humerus) and asserts that the intended use and fundamental scientific technology have not changed from the previously cleared submissions (K992515, K981483).

Therefore, this 510(k) notification represents a "Special 510(k) Device Modification" which primarily relies on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than requiring new clinical studies or detailed performance data against specific acceptance criteria for performance metrics typically seen with novel devices or significant design changes impacting clinical outcomes.

As such, the information you've asked for regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this specific regulatory submission.

Here's why and what information is available based on your request:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. This Special 510(k) emphasizes substantial equivalence to a predicate device based on material changes (addition of carbon fiber) and minor design modifications (posterior bone screw placement components), without altering the fundamental technology or intended use. Performance acceptance criteria and reported device performance, in the sense of clinical effectiveness or safety metrics, are not typically required for such submissions when substantial equivalence is established through comparison to a legally marketed predicate. The "performance" being evaluated here is the device's continued conformity to the predicate's established safety and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. No new clinical or performance test data (test set) is presented in this 510(k) summary for evaluation against specific metrics. The "test" here is the regulatory comparison to the predicate device.

3. 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 clinical ground truth assessment by experts for new performance data was conducted or reported in this submission.

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

Not Applicable. As no new clinical testing generating a test set requiring adjudication was performed or reported.

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 a hardware device (external fixator), not an AI/software device. No MRMC study was conducted.

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

Not Applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

Not Applicable. Ground truth, in the clinical sense, is not relevant for this type of submission. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not Applicable. This is a hardware device, not an AI/machine learning device that would utilize a training set in that context.

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

Not Applicable. See point 8.

Summary of the Regulatory Basis for this Submission:

Device Type: Special 510(k) Device Modification for an External Fixation Device.
Key Modification: Addition of a carbon fiber ulnar bar and components for posterior bone screw placement in the humerus.
Claim for Substantial Equivalence: The submission asserts that the modified device is substantially equivalent to its predicate devices (EBI® XFIX® DFS® OptiROM® Elbow Fixator K981483, K992515) with regard to:
- Intended Use: Remains the same (upper extremity treatment for bone/soft tissue conditions, including fracture dislocation, comminuted intra-articular fractures, and post-traumatic reconstruction for joint stiffness).
- Materials: Same materials as predicate, with the addition of carbon fiber.
- Function: Designed for fixation of bar and bone screw, similar to the predicate.
- Sterility: Both are provided non-sterile.

The "study" in this context is the comparison of the technological characteristics of the modified device to the predicate device, as detailed in section 7 of the 510(k) Summary. The acceptance criterion for this type of submission is demonstrating that "there are no significant differences" between the modified device and the predicate device that would raise new questions of safety or effectiveness. The FDA's letter (K020403) confirms that they "have determined the device is substantially equivalent" to legally marketed predicate devices, thereby meeting this regulatory acceptance criterion.

Summary

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Special 510(k) Device Modification: EBI® XFIX® DFS® OptiROM® Elbow Fixator

K000403
page 1 of 2

510(k) Summary

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

Contact Person: Patricia Flood, RAC 1. Sponsor: (973) 299-9300, ext.3318 Telephone: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Date Prepared: February 6, 2002

2. Proprietary Name:	EBI® XFIX® DFS® OptiROM® Elbow Fixator
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® DFS® OptiROM® Elbow Fixator (K992515, K981483) .

4. Description of Device:

5. Intended Use:

The EBI XFIX DFS OptiROM Elbow Fixator is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

Fracture dislocation with ligamentos instability.

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K020403
page 20fa

Comminuted intra-articular fractures. Post traumatic reconstruction for joint stiffness.

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 DFS OptiROM Elbow Fixator is substantially equivalent to the following predicate device:

EBI XFIX DFS OptiROM Elbow Fixator (K981483, K992515)

The additional EBI XFIX DFS OptiROM Elbow Fixator components . are fabricated from the same materials as the components of the currently marketed EBI XFIX DFS OptiROM Elbow Fixator, with the addition of carbon fiber.
The modified EBI XFIX DFS OptiROM Elbow Fixator and the currently . marketed EBI XFIX DFS OptiROM Elbow Fixator are both intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

Fracture dislocation with ligamentos instability. Comminuted intra-articular fractures. Post traumatic reconstruction for joint stiffness.

The bone screw clamps of the modified EBI XFIX DFS OptiROM Elbow ● Fixator, like the bone screw clamps currently marketed in the EBI XFIX DFS OptiROM Elbow Fixator, are designed for fixation of the bar and bone screw.
The modified EBI XFIX DFS OptiROM Elbow Fixator, like the currently ● marketed EBI XFIX DFS OptiROM Elbow Fixator, is provided nonsterile.

There are no significant differences between the modified EBI XFIX DFS OptiROM Elbow Fixator and the currently marketed EBI XFIX DFS OptiROM Elbow Fixator. 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 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

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

Re: K020403 Trade/Device Name: EBI® XFIX® DFS® OptiROM® Elbow Fixator Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: February 6, 2002 Received: February 7, 2002

Dear Ms. Flood:

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 rommerce 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 oney, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , answer , 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. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wy of a finding of substantial equivalence of your device to a legally promatics noticated. " 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Ouvision 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,

Mark A. Miller

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 l

510(k) Number (if known): KOLL CS /03 EBI® XFIX® DFS® OptiROM® Elbow Fixator Device Name: Indications For Use:

Fracture dislocation with ligamentos instability.
Comminuted intra-articular fractures.
Post traumatic reconstruction for joint stiffness.

(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)

fo Mark N Millam

/ (Division Sign-Off)
Division of General Restorative

510(k) Number K020403

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.