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 distractor component, which allows for gradual movement used in rehabilitation. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

AI/ML Overview

The provided document is a 510(k) Summary for a Special 510(k) Device Modification for the EBI® XFIX® DFS® OptiROM® Elbow Fixator. This type of submission is used when a modification to an existing, legally marketed device does not significantly alter its fundamental scientific technology or intended use.

Therefore, the document does not describe a new study to prove the device meets acceptance criteria in the way a new device would. Instead, it argues for substantial equivalence to existing predicate devices based on the lack of significant changes in technological characteristics, materials, and intended use.

Here's an analysis based on the provided text, highlighting that many of the requested items (like acceptance criteria, sample sizes, ground truth establishment, MRMC studies) are not applicable or not present in a 510(k) for a device modification of this nature:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable/Not Provided: This document is a 510(k) for a device modification, not a submission for a new device requiring detailed performance studies against specific acceptance criteria. The modification is for the addition of a distractor component to an already cleared external fixator. The argument is for "substantial equivalence" based on the absence of significant changes. There are no detailed performance metrics or acceptance criteria presented for the modified device in this document, as the FDA typically considers the original device's performance already established.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable/Not Provided: No "test set" in the context of a performance study (like clinical trials or benchmark testing) is mentioned or implied. The substantial equivalence argument relies on comparing the modified device's characteristics (materials, intended use, function) to the predicate device, not on new performance data from a specific test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable/Not Provided: Since there's no "test set" and no new performance study described, there's no mention of experts establishing ground truth. The evaluation is focused on regulatory comparison.

4. Adjudication Method for the Test Set:

Not Applicable/Not Provided: As no performance study with a test set is described, there is no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, not performed/not applicable: MRMC studies are typically for evaluating diagnostic or interpretive tools, often comparing human performance with and without AI assistance. This document describes a mechanical external fixation device. Such a study would not be relevant.

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

No, not performed/not applicable: This is a mechanical device, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used:

Not Applicable/Not Provided: There is no performance study that requires a "ground truth" to be established in the context of this 510(k) submission. For a medical device of this type, a "ground truth" might refer to pathological confirmation or patient outcomes if a clinical trial were conducted, but that's not described here.

8. The Sample Size for the Training Set:

Not Applicable/Not Provided: This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable/Not Provided: As this is not an AI/ML device, there is no training set or ground truth for a training set.

Summary of Device and 510(k) Argument:

Device: EBI® XFIX® DFS® OptiROM® Elbow Fixator
Modification: Addition of a distractor component, allowing for gradual movement in rehabilitation.
Reason for 510(k): Special 510(k) Device Modification, asserting substantial equivalence to the predicate device (EBI® XFIX® DFS® OptiROM® Elbow Fixator K981483, K992515, K020403).
Key Argument for Substantial Equivalence:
- The additional component is made from the same materials as existing components.
- The intended use and fundamental scientific technology have not changed.
- The modified device's applications (fracture dislocation with ligamentous instability, comminuted intra-articular fractures, post-traumatic reconstruction for joint stiffness) are the same as the predicate device.
- Bone screw clamps are designed for fixation of the bar and bone screw, similar to the predicate.
- The device is provided non-sterile, like the predicate.
Conclusion: The submission concludes there are no significant differences, making it substantially equivalent in intended use, materials, and function. The FDA concurred with this assessment, permitting the device to be marketed.

Summary

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021312

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

510(k) Summary

This 510(k) Summary for the EBI® XFIX® DFS® OptiROM® Elbow Fixator is provided as required per Section 513(1)(3) of the Federal Food, Drug and Cosmetic Act.

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

Date Prepared: April 24, 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, ● K0202403)

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:

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Fracture dislocation with ligamentos instability. 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, K020403)

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.
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 evident 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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AY 2 3 2007

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

Re: K021312

K021912
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: April 24, 2002 Received: April 25, 2002

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter will anow you to ought and ing of substantial equivalence of your device to a legally premits to the month. The 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 11 you desire specific acres 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far are 659. Additionally, for questions on the promotion and advertising of Compination at (301) 597-1699 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisocrange jesponsibilities under the Act may be obtained from the Other general information of the mational 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 McMillan

Celia 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

510(k) Number (if known): KON / 310

Device Name: EBI® XFIX® DFS® OptiROM® Elbow Fixator

Indications For Use:

1. Fracture dislocation with ligamentos instability.
1. Comminuted intra-articular fractures.
1. 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)

Marl N. Mllkerson

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

510(k) Number K021312

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.