EBI XFIX DFS RAIL SYSTEM by ELECTRO-BIOLOGY, INC.

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 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "EBI XFIX DFS® Rail System," an external fixation device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that the new device meets specific performance acceptance criteria through a clinical study or a standalone algorithm study in the way modern AI/ML devices do.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this 1999 510(k) submission for a physical medical device. These elements are typically associated with performance studies for software as a medical device (SaMD) or AI-powered diagnostics.

Here's a breakdown of what can be extracted and what is not applicable based on the provided document:

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

Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence to predicate devices, not a report of performance against specific acceptance criteria in a study for a new device type (like an AI/ML product). The FDA's determination of substantial equivalence means the device is as safe and effective as a legally marketed predicate device.

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

Not Applicable. No test set or associated data provenance is described in this 510(k) summary. The submission relies on a comparison of technological characteristics to predicate devices.

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. There is no mention of a test set, ground truth, or expert involvement for performance evaluation described in this 510(k) summary.

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

Not Applicable. No test set or adjudication method is described.

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 a physical external fixation system, not an AI or diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant and not mentioned.

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

Not Applicable. This is a physical medical device, not a standalone algorithm.

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

Not Applicable. Ground truth is not established or used as part of this 510(k) submission, which is based on demonstrating substantial equivalence to existing devices.

8. The sample size for the training set

Not Applicable. There is no training set for an algorithm mentioned in this submission.

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

Not Applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided document is a regulatory submission demonstrating the substantial equivalence of a physical medical device (EBI XFIX DFS® Rail System) to existing predicate devices based on its intended use, materials, and technological characteristics. It does not describe performance studies involving acceptance criteria, test sets, ground truth, or AI/ML evaluations.

Summary

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K99/94)
10Fa

510(k) Summary of Safety & Effectiveness

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

Electro-Biology, Inc. Contact Person: Jonas Wilf 1. Sponsor: 100 Interpace Parkway Telephone: (973) 299-9022 Parsippany, NJ 07054

Date prepared: June 8, 1999

2. Proprietary Name:	EBI XFIX DFS® Rail System
Common Name:	External Fixation Device
Classification Names:	Single Multiple Component Metallic BoneFixation Appliances and Accessories, 21 CFR 888.3030.

1. Predicate or legally marketed devices that are substantially equivalent:
으 EBI XFIX DynaFix Fixation System - Electro-Biology, Inc.
The Adult Limb Reconstruction System Orthofix. Inc. t
Heidelberg External Fixator Smith and Nephew, Inc. .
Description of the device: The system consists of fixation components and 4. implantable bone screws. The EBI XFIX DFS Rail System is utilized in the following manner: bone screws are inserted through the patient 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.
Intended Use: The EBI XFIX DFS® Rail System is a unilateral external fixation ડ. 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.
Materials: The components of the system may be manufactured from materials such 6. as Aluminum, Stainless Steel, Pyromet® 718, and Ti-6Al-4V ELI,
1. Comparison of the technological characteristics of the device to predicate devices:

The EBI XFIX DFS Rail System is substantially equivalent to the following predicate EBI and competitive devices. The components of the EBI XFIX DFS

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K 99 1941
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Rail System are fabricated from the same materials as the components of the currently marketed EBI XFIX DynaFix Fixation System.

The bone screw clamps of the EBI XFIX DFS Rail System, like the bone screw . clamps currently marketed competitive Adult Limb Reconstruction System -Orthofix, Inc. and EBI XFIX DynaFix Fixation System, are designed for attachment
to the bone screws. In addition the bone screw clamps of the EBI XFIX DFS Rail System and the competitive Adult Limb Reconstruction System - Orthofix, Inc are designed to track along the length of the rail.
The Compression Distraction Clicker of the design of the EBI XFIX DFS Rail . System, like the currently marketed competitive Adult Limb Reconstruction System - Orthofix, Inc. and Heidelberg External Fixator-Smith & Nephew, is designed to provide the surgeon the ability to compress or distract the bone of the patient postoperatively for optimal treatment.
The EBI XFIX DFS Rail System like the currently marketed EBI XFIX DynaFix Fixation System and competitive Adult Limb Reconstruction System - Orthofix, Inc. and Heidelberg External Fixator-Smith & Nephew, is provided non-sterile. There are no significant differences between the EBI SpineLink™ System and other currently marketed spinal systems. It is substantially equivalent* to the predicate devices in regards 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 the product can be lawfully market 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 Premation 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure in profile, with the lines representing the head, body, and legs. The overall design is simple and conveys a sense of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1999

Mr. Jon Caparotta Manager, Regulatory Affairs Electro-Biology, Incorporated 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K991941

Trade Name: EBI XFIX DFS® Rail System Regulatory Class: II Product Code: KTT Dated: June 8, 1999 Received: June 9, 1999

Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, EDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jon Caparotta

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell S. Rogers

Sa~Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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×991941

Statement of Indications for Use:

Russell H. Vayner Su, Jr.

ivision Sign-Off) of General icos 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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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.