The ISKD System is an intramedullary limb lengthening system that provides gradual, controlled osteogenic distraction of the tibia and femur. The ISKD System consists of the telescoping internal limb lengthening device, titanium locking screws, instrumentation and an external handheld Monitor. As the patient performs rotational oscillations of the affected limb during normal ambulation, the ISKD distracts as the distal section of the implant gradually telescopes out of the proximal section. The distraction is controlled by a one-way clutch mechanism and a threaded rod. A small magnet sealed within the ISKD implant rotates simultaneously as the implant distracts. The hand-held external Monitor is similar to an electronic compass and communicates with the magnet by detecting a tracking changes in the magnet poles. The external Monitor enables both patients and physicians to monitor the daily limb lengthening progress. The addition of the 10.7mm lengthener will provide surgeons with a device option for patients requiring a smaller diameter implant.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Orthofix Inc. ISKD Internal Limb Lengthening System (10.7mm), seeking substantial equivalence to a previously cleared 12.5mm version of the same device. This type of regulatory submission focuses on demonstrating equivalence to a predicate device, rather than proving efficacy through clinical outcome studies with predefined acceptance criteria for device performance as would be seen in AI/ML device submissions.

Therefore, the study described is a biomechanical testing study demonstrating the mechanical properties of the new 10.7mm device are comparable to the predicate device, rather than a study evaluating diagnostic or prognostic performance of an AI/ML algorithm.

Here's a breakdown based on the provided input:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from predicate device performance)	Reported Device Performance (10.7mm ISKD)
Mechanical properties necessary to perform intended use as per ASTM 1264 for intramedullary fixation devices.	Successfully completed 4-point bend, fatigue, and torsion testing in accordance with ASTM 1264.
Performs as well as the 12.5mm ISKD lengthener (predicate device).	Performs as well as the 12.5mm ISKD lengthener.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number of devices. The study refers to "mechanical and functional testing" of the 10.7mm lengthener. For biomechanical testing, samples typically refer to a defined number of devices or components tested.
Data Provenance: The testing was conducted by Orthofix Inc. The document implies these were laboratory-based tests on the manufactured devices, not human or animal data. There is no information on country of origin of data beyond it being conducted by the submitter (Orthofix Inc. in McKinney, TX, USA). It is a prospective test in the sense that the new device was manufactured and then tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as this is a biomechanical engineering study, not one requiring expert review of data (e.g., medical images). The "ground truth" is defined by the ASTM standard 1264.

4. Adjudication method for the test set:

This information is not applicable for a biomechanical engineering study. The evaluation likely involved direct measurement against the ASTM standard.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This document describes a medical device (internal limb lengthener), not an AI/ML diagnostic or assistive technology.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this study is the ASTM 1264 Standard Specification and Test Methods for Intramedullary Fixation Devices. The performance of the 10.7mm device was evaluated against the requirements and performance established by this recognized standard, and comparatively against the performance of the 12.5mm predicate device.

8. The sample size for the training set:

There is no training set as this is not an AI/ML study.

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

There is no training set as this is not an AI/ML study.

Summary

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MAY 2 8 2003

K031219
Page 1 of 3

SUMMARY OF SAFETY AND EFFECTIVENESS Orthofix Inc. ISKD Internal Limb Lengthening System

1. GENERAL INFORMATION

Classification Name:	Intramedullary fixation rod
Common Name:	Internal Limb Lengthener
Device Trade Name:	"ISKD":(Intramedullary Skeletal KineticDistractor)
Classification Code(s):	21 CFR Parts 888.3020
Submitter's Name & Address:	Orthofix Inc.1720 Bray Central DriveMcKinney, TX 75069(469) 742-2561
Establishment Registration No:	2183449
Contact Person:	Mary Biggers, RAC469-742-2561
Summary Preparation Date:	April 7, 2003

11. Predicate Device

The Orthofix Inc. ISKD System 10.7mm internal limb lengthener is substantially equivalent in design, function and intended use to the Orthofix Inc. 12.5mm internal limb lengthener. The Orthofix ISKD 12.5mm internal limb lengthener, manufactured by Orthofix Inc. of McKinney, Texas, was originally cleared by FDA under K010322 on May 2, 2001.

111. DEVICE DESCRIPTION

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31219
page 2 of 3

electronic compass and communicates with the magnet by detecting a tracking changes in the magnet poles. The external Monitor enables both patients and physicians to monitor the daily limb lengthening progress. The addition of the 10.7mm lengthener will provide surgeons with a device option for patients requiring a smaller diameter implant.

IV. INDICATIONS FOR USE

The ISKD System intended for limb lengthening of the femur and tibia.

V. BIOMECHANICAL TESTING

In order to demonstrate that the 10.7 ISKD Limb Lengthener has the mechanical properties necessary to perform its intended use, and that the ISKD Internal Limb Lengthener performs as well as or better than the predicate device, Orthofix has conducted mechanical and functional testing of the 10.7mm lengthener in accordance with ASTM 1264. Standard Specification and Test Methods for Intramedullary Fixation Devices. These tests consist of 4-point bend, fatigue and torsion testing. The testing was successfully completed demonstrating the 10.7mm lengthener performs as well as the 12.5mm ISKD lengthener.

VI. BIOCOMPATIBILITY

The ISKD Internal Limb Lengthening device and locking screws are made from titanium alloy, Ti6A14V ELI conforming to ASTM F136.

X. Sterilization

The ISKD Internal Limb Lengthener is sterilized by exposure to ethylene oxide gas. The Instrumentation and devices provided non-sterile must be sterilized prior to use using the parameters identified below:

ISKD Non-Sterile Devices/Instruments
Method	Steam Sterilization
Cycle	Pre-Vacuum
Temperature	132° - 135° C [270° - 275°F]
Exposure Time	Minimum of 10 minutes
Sterility Assurance Level (SAL)	10-6
Sterility Validation Method	ANSI/AAMI ST46-1993- PrevacuumSteal Sterilization of Medical Devices

X. SUBSTANTIAL EQUIVALENCE

The 10.7mm ISKD Tibial Internal Limb Lengthener is claimed to be substantially equivalent in design and function to the 12.5mm ISKD Tibial Internal Limb Lengthener. The 12.5mm ISKD received 510(k) clearance under K010322 on May 2, 2001.

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031219
page 3 of 3

Features	ISKD 10.7mm	ISKD 12.5MM
Intended Use	"Limb lengthening of the tibiaand femur"	"Limb lengthening of the tibia andfemur"
MATERIAL	Ti6A14V ELI	Ti6A14V ELI
DESIGN FEATURES	Intramedullary nailTelescoping sectionsOne way clutch design	Intramedullary nailTelescoping sectionsOne way clutch design
METHOD OFFIXATION	4.0 mm & 4.8mm diameterlocking screws	4.8mm diameter locking screws
NUMBER OFFIXATION POINTS	2 proximal/2 distal	2 proximal/2 distal
DESIGN OF ENDS	Blunt	Blunt
CROSSSECTIONAL SHAPE	Circular	Circular
RATE OFLENGTHENING	Physician to determine rate.Dependent upon patientactivity level; .75-1.25 mm/day	Physician to determine rate.Dependent upon patient activity level;.75-1.25 mm/day
CONTROL OFLENGTHENING	Patient's activity level, i.e.,rotational oscillations of thelimb	Patient's activity level, i.e., rotationaloscillations of the limb
MONITORING OFDISTRACTION	External hand held monitor;X-rays for confirmation	External hand held monitor;X-rays for confirmation
SAFETY FEATURES	Automatic stop whenpredetermined length isachieved. And one-way clutchdesign	Automatic stop when predeterminedlength is achieved. And one-wayclutch design
SIZE RANGES(LENGTHS)	10.5 (215-350mm)	12.5 (255-435mm)
INVASIVECOMPONENTS	Intramedullary limb lengthener,Locking screws	Intramedullary limb lengthenerLocking screws

XI. CONCLUSION

Based upon the results of biomechanical testing the ISKD 10.7mm internal limb lengthener has the mechanical properties to perform its intended use of limb lengthening of the tibia and is considered to be substantially equivalent to the predicate device in design, material and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Public Health Service

__ and, and I will be happy to help.

MAY 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Biggers, RAC Manager, Regulatory Affairs Orthofix, Inc. 1720 Bray Central Drive McKinney, Texas 75069

Re: K031219

Trade/Device Name: ISKD (Intramedullary Skeletal Kinetic Distractor) System Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: April 11, 2003 Received: April 17, 2003

Dear Ms. Biggers:

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 (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 - Ms. Kim P. Kelly, MS

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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 N. Malkinson

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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Indication for Use Statement

Page 1 of 1

K0312i9

510(k) Number (if known):

Device Name:

"ISKD" Intramedullary Skeletal Kinetic Distractor

Indications for Use:

The ISKD is indicated for limb lengthening of the tibia and femur.

(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 (Optional Format 1-2-96)

for Mark A. Millerman

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

510(k) Number K0310

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.