The EBI XFIX® DFS® Metaphyseal Correction 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 EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction 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® Metaphyseal Correction System is attached to the shanks of the bone screws. This submission is for additional components.

AI/ML Overview

The provided text is a 510(k) Summary for the EBI XFIX® DFS® Metaphyseal Correction System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like a novel device would. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.

Here's what can be inferred and what is explicitly not mentioned in the document based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Substantial Equivalence to predicate device	"There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction System and other currently marketed external fixation systems. It is substantially equivalent to the predicate devices in regards to intended use, materials, and function."	The primary "acceptance criterion" for a 510(k) submission like this is substantial equivalence to a legally marketed predicate device. The document explicitly states this is met. Specific performance metrics like accuracy, sensitivity, or specificity are not part of this type of submission for this device.

Study Details (Based on the 510(k) Summary)

Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a performance study with a test set. It relies on demonstrating substantial equivalence to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study with a test set requiring expert ground truth is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No performance study requiring adjudication is described.
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 not an AI-assisted device, and no MRMC study is described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical external fixation device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for a physical device demonstrating substantial equivalence. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable. As above, this is not an AI/ML device.

Summary of Device and 510(k) Content:

The EBI XFIX® DFS® Metaphyseal Correction System is an external fixation device used for conditions like leg lengthening, osteotomies, arthrodesis, and fracture fixation. The 510(k) submission (K001358) states that it has not changed the Indications for Use or fundamental scientific technology of the previously cleared system (EBI XFIX® DFS® System). The primary argument for clearance is that the device is substantially equivalent to its predicate device in terms of intended use, materials (titanium, stainless steel, aluminum), and function. This type of submission typically does not include new clinical performance studies or specific accuracy/performance metrics, as it relies on the established safety and effectiveness of the existing predicate device. The submission explicitly states there are "no significant differences."

Summary

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K001358

510(k) Summary of Safety & Effectiveness

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

1. Submitter: EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person: Jon CaparottaTelephone: (973) 299-9022
Date prepared: April 27, 2000
2. Proprietary Name:	EBI XFIX® DFS® Metaphyseal CorrectionSystem
Common Name:	External Fixation Device
Classification Names:	Single/Multiple Component Metallic BoneFixationAppliances and Accessories, 21 CFR 888.3030

1. Predicate or legally marketed devices that are substantially equivalent:
- EBI XFIX® DFS® System EBI, L.P. �
1. Description of the device: The EBI XFIX® DFS® Metaphyseal Correction System has not changed the Indications for Use or fundamental scientific technology of the previously cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX® DFS® Metaphyseal Correction 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® Metaphyseal Correction System is

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attached to the shanks of the bone screws. This submission is for additional components.

1. Intended Use: The EBI XFIX® DFS® Metaphyseal Correction 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.
1. Materials: The components of the System may be manufactured from materials such as titanium, stainless steel, and aluminum.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI XFIX® DFS® Metaphyseal Correction System and other currently marketed external fixation 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 to whether the product can be lawfully marketed without pre-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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Jon Caparotta Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054-1079

Re: K001358

Trade Name: EBI XFIX® DFS® Metaphyseal Correction System Regulatory Class: II Product Code: KTT Dated: April 27, 2000 Received: April 28, 2000

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, FDA 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.

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.

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Page 2 - Mr. Jon Caparotta

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dona R. Lochner

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

1_of_1 Page

510(k) Number (if known): との01ろ58

Device Name: EBI XFIX® DFS® Metaphyseal Correction System

Indications For Use:

The EBI XFIX® DFS® Metaphyseal Correction 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

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Dune R. Lochner

vision Sign-Off Division of General Restorative Devices 510(k) Number K 001358

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.