The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices 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® Access™ Pelvic Fixator has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic 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® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.

AI/ML Overview

This 510(k) summary describes a device, the EBI® XFIX® Access™ Pelvic Fixator, which is a physical medical device and not an AI/ML powered device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through material changes (carbon fiber bar replacing a titanium bar). Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth, which are typically relevant for AI/ML device evaluations, are not applicable to this submission.

The closest information provided related to device performance is a general statement about compliance with applicable standards and meeting all functional requirements for the modified device.

Here's a breakdown of why each requested point is not present in the provided document, given the nature of the device:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or quantitative performance metrics typically seen for AI/ML devices (e.g., sensitivity, specificity, AUC). The submission's focus is on material equivalence and functional equivalence for a physical fixator.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm for this physical device. The testing likely involved mechanical and material performance tests, not data analysis on patient cases.
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 ground truth, expert consensus, or clinical data analysis in the manner expected for AI/ML.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
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 diagnostic or decision-support device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The information in this 510(k) pertains to a physical medical device (an external fixator) and not an AI/ML algorithm. As such, the specific criteria and study details requested (which are typical for AI/ML device evaluations) are not present in the document. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily by showing that a material change (carbon fiber bar) maintains the device's intended use and functional requirements.

Summary

{0}------------------------------------------------

K011697

JUN 2 7 2001

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® XFIX® Access™ Pelvic Fixator is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

Submitter: EBI, L.P. 1. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Jon Caparotta, RAC Telephone: (973) 299-9022

Date prepared: May 31, 2001

1. Proprietary Name: Common Name: Classification Names:
  EBI® XFIX® Access™ Pelvic Fixator External Fixation Device Single Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030.
Predicate or legally marketed devices that are substantially equivalent: 3.
· EBI® XFIX® DFS® System - Electro-Biology, Inc.
Description of the device: The EBI® XFIX® Access™ Pelvic Fixator has not changed 4. the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI® XFIX® Access™ Pelvic 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® Access™ Pelvic Fixator is attached to the shanks of the bone screws. This submission is for the use of a carbon fiber bar that will replace the current titanium bar.
Intended Use: The EBI® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are ર. unilateral external fixation devices 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.
Materials: The components of the system are manufactured from materials such as Ti-6A1-4V 6. ELI, Aluminum, Stainless Steel, and Carbon Fiber.

{1}------------------------------------------------

Comparison of the technological characteristics of the device to predicate devices: There are 7. no significant differences between the EBI® XFIX® Access™ Pelvic Fixator m and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission of substantial equivalial equivalence to any of the product is not * Any statement made in conjunction with uns submitted without re-markt and to reclassified ion and is not intended only to relate to when the product on the research infringened fities one thit one (Establishment Registration intended to be interpreted as an admission of any outer type of evidence in packs and any works.
and Premarket Notification Procedures, Final Regulation, Preamble, August 23,

{2}------------------------------------------------

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 stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2001

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

Re: K011697

Trade Name: EBI XFIX Access Pelvic Fixator Regulation Number: 888.3030 Regulatory Class: II Product Codes: KTT Dated: May 31, 2001 Received: June 1, 2001

Dear Mr. Caparotta:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally it (x) is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the cherosure) to device Amendments, or to devices that have been reclassified in enacificili dato of the Fredical Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general control provisions of the Act. The general therefore, market the do rece sacjes to quirements for annual registration, listing of devices, control provisions or the fire, 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 (1 Chiarket Approval), it they of Sale, Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially equirement, 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 mispections, the Food and Dation may result in regulatory action. In addition, FDA may publish comply with the Criti regular 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.

{3}------------------------------------------------

Page 2 -- Mr. Jon Caparotta, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific as a vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The classicstions on the promotion and advertising of your device, (2017) 594-4639 f 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 Information on your responsionally tree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Michlberger

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

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

Page 1 of of 1

510(k) Number (if known):

Device Name: EBI® XFIX® Access ™ Pelvic Fixator

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Psmhulelcoms for CAUI

(Division Sign-Off) (Division Bigger Crail, Restorative Divisiourological Devices

510(k) Number_401027

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.