The EBI® DynaFix® Vision® FootPlate System intended for use in the treatment of the HDP by na in and other osteotomies, arthrodesis, fracture fixation, and other bone bond tone able to treatment by the use of the external fixation modality.

Device Description

External Fixation Device

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Conforms to design specifications	"the FootPlate System conforms to its design specifications."
Functions as intended	"In all instances, the FootPlate System functioned as intended"
Test results obtained as expected	"the test results obtained were as expected."
Mechanically sound (static)	Mechanical testing verified static design specifications.
Mechanically sound (fatigue)	Mechanical testing verified fatigue design specifications.
Safe and effective as predicate devices (DFS and Vision Systems)	"Performance data demonstrate that the FootPlate System is as safe and effective as the DFS System and Vision System."
No new issues of safety or effectiveness compared to predicate devices	"The minor technological differences... raise no new issues of safety or effectiveness."

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

The document describes mechanical testing rather than a study involving human or animal subjects and data provenance. For the mechanical testing performed:

Sample Size for Test Set: Not explicitly stated as a number of devices. The study mentions that an "Engineering Rationale was written to demonstrate that the mechanical testing conducted represented the worst case construct and why further testing on the additional sizes of FootPlate System components is unnecessary." This implies that representative samples of the FootPlate System, likely the worst-case configuration, were tested.
Data Provenance: Not applicable as this was mechanical testing of a medical device, not a clinical study on patients.

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. Ground truth as typically understood in studies involving expert review (e.g., medical image analysis) is not relevant for this type of mechanical device testing. The "ground truth" here is the physical performance and adherence to engineering specifications, which is assessed through standardized mechanical tests.

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

Not applicable. Adjudication methods are typically used in studies where human experts are making judgments that need to be reconciled (e.g., clinical diagnoses). This was mechanical testing, where performance is measured objectively.

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 510(k) summary for a mechanical external fixation device, not a diagnostic or AI-powered device. Therefore, an MRMC study or AI assistance evaluation is not relevant.

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

Not applicable. This is not an AI algorithm or software device.

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

The "ground truth" for this device's performance is its physical and mechanical properties measured against predefined design specifications and engineering standards. This includes:

Static design specifications
Fatigue design specifications
Expected functional performance

These aspects are evaluated through controlled mechanical testing.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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

K052239

SEP 2 1 2005

510(k) SUMMARY

EBI, L.P.'s

EBI® DynaFix® Vision® FootPlate System

SUBMITTER:	EBI, L.P.
ADDRESS:	100 Interpace ParkwayParsippany, NJ 07054
PHONE:	(973) 299-9300
FAX:	(973) 257-0232
CONTACT PERSON:	Peter Allan
DATE PREPARED:	August 16, 2005
TRADE NAME:	EBI® DynaFix® Vision® FootPlate System
COMMON NAME:	External Fixation Device
CLASSIFICATION NAME:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories, 21 CFR 888.3030
CLASSIFICATION #:	Class II
PREDICATE DEVICES:	EBI® XFIX® DFS® System, EBI® XFIX® Vision®Fixation System, Howmedica OsteonicsCorporation Hoffmann® II Foot Ring

INTENDED/INDICATIONS FOR USE:

Intended for use in the treatment of bone conditions including osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation modality.

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

TECHNOLOGICAL CHARACTERISTICS:

Performance Data

Mechanical testing of the FootPlate System was conducted which demonstrates that the FootPlate System conforms to its design specifications. Additionally, an Engineering Rationale was written to demonstrate that the mechanical testing conducted represented the worst case construct and why further testing on the additional sizes of FootPlate System components is unnecessary. Mechanical testing was performed on the FootPlate System to verify the static and fatigue design specifications. In all instances, the FootPlate System functioned as intended and the test results obtained were as expected.

Substantial Equivalence

The FootPlate System is as safe and effective as the DFS and Vision Systems and has the same intended uses and similar indications, technological characteristics and principles of operation as its EBI® predicate device. The minor technological differences between the FootPlate System and its EBI® predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the FootPlate System is as safe and effective as the DFS System and Vision System. Thus, the FootPlate System is substantially equivalent. Additionally, the FootPlate System has the same intended anatomical use as the Hoffmann® II Foot Ring predicate device.

K052239

6²/₂ 14

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

Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.

Public Health Service

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Allan EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K052239 Trade/Device Name: EBI® DynaFix® Vision® FootPlate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: August 16, 2005 Received: August 17, 2005

Dear Mr. Allan:

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 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) 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Peter Allan

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mailteing your device of your device to a legally premarket nother in the PDF Intellig of basification 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), please If you desire specific advice for your don't to the news note the regulation entitled, a Contact the Office of Complance in (21 trip Part 807.97). You may obtain MISofanding by reference to premailters under the Act from the Division of Small other general information on your response 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 N. Malkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EBI® DynaFix® Vision® FootPlate System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over The Counter Use_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

\\DC - 71403/0600 - 1352963 v6

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.