The Integra External Fixation System is an 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. Additional indications for the Integra External Fixation System include:

Correction of deformity
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Fusions and replantations of the foot
Charcot reconstruction and Lisfranc dislocations
Ankle distraction (arthrodiastasis)

Device Description

The Integra® External Fixation System is a single-use modular external fixator consisting of the following components: rings, foot plates, compression/distraction struts, half-pin bone screws, straight/olive wires, rods, nuts, bolts, clamps, and other modular fixator components. Special instruments (e.g. wrenches) are required for proper assembly of the apparatus. Adjustment of the fixator is possible during the course of treatment. When properly used by an experienced clinician, the Integra External Fixation System may preserve limb function by minimizing operative trauma to anatomical structures and preserving blood supply.

AI/ML Overview

The Integra External Fixation System is a medical device and the provided text describes its regulatory clearance, not a study of its clinical performance with acceptance criteria typical for AI/software devices. The information available pertains to the mechanical performance of the device compared to a predicate, not clinical outcomes. Therefore, many of the requested categories for AI/software studies are not applicable.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not available or not applicable:

Acceptance Criteria and Study for Integra External Fixation System (K140463)

The provided document describes the FDA 510(k) clearance for the Integra External Fixation System. This is a mechanical device, and the study described focuses on demonstrating its substantial equivalence to a predicate device through mechanical testing. It is not an AI/software device, and therefore, many of the requested metrics related to clinical studies, expert-based ground truth, and human-in-the-loop performance are not applicable or not provided in this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described relate to the mechanical stiffness of the Integra External Fixation System compared to a predicate device.

Acceptance Criteria Objective	Acceptance Criteria	Reported Device Performance
Mechanical Stiffness	"The stiffness of the 2 systems was compared and was statistically equivalent."	"The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of number of devices tested, but it refers to "the construct" of both the predicate and the Integra system. This typically implies a statistically sufficient number of physical devices or components to perform mechanical testing.
Data Provenance: The study was a prospective mechanical testing conducted by the manufacturer
(Ascension Orthopedics/Integra LifeSciences). The country of origin for the data is not specified but would likely be the location where the manufacturer's testing facilities are located (e.g., USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For mechanical device testing, "ground truth" is established by standard engineering principles and validated testing methodologies, not by clinical experts. The testing would be performed by engineers or technicians skilled in biomechanical testing.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation or consensus, typically for diagnostic or prognostic devices. This was a mechanical engineering study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was a mechanical engineering comparison of two external fixation systems, not a clinical study involving human readers or AI assistance in interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not Applicable. This is a mechanical device, not an algorithm. There is no "standalone" algorithmic performance to report.

7. Type of Ground Truth Used

The "ground truth" for this engineering study was the mechanical stiffness measured under dynamic and static loading conditions, as per established biomechanical testing standards. This would be quantified by physical measurements obtained from calibrated testing equipment.

8. Sample Size for the Training Set

Not Applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for this type of device, this question is not relevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

Ascension Orthopedics % Mr. Steven Brown IMDS 560 West Golf Course Road Providence, Utah 84332

Re: K140463 Trade/Device Name: Integra External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. Brown:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3: INDICATIONS FOR USE

510(k) Number (if known): K140463 Device Name: Integra External Fixation System Indications for Use: INDICATIONS FOR USE

Correction of deformity
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Fusions and replantations of the foot
· Charcot reconstruction and Lisfranc dislocations
· Ankle distraction (arthrodiastasis)

AND/OR Prescription Use Over-the-Counter Use (21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

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Section 4: 510(k) SUMMARY

Device Trade Name: Integra External Fixation System

Date: October 1, 2014

Sponsor:

Integra LifeSciences Corporation

Contact Person:

Integra Life Sciences Corp Frederic Testa Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536 609-936-3630 frederic.testa@integralife.com

Manufacturer:

Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 609-936-3630 frederic.testa@integralife.com

Common Name:	External Fixation Device
Device Classification:	Class II
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030)
Regulation:	21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories
Device Regulation Panel:	Orthopedic

Device Product Code: Orthopedic KTT

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Device Description:

Implants:

Half-pin Bone Screws

The self-drilling half-pin bone screw is 200mm in length and offered in the following sizes: 4mm diameter w/ 20mm thread length, 4mm diameter w/ 30mm thread length, 4mm diameter w/ 40mm thread length, 5mm diameter w/ 30mm thread length. 5mm diameter w/ 40mm thread length. 5mm diameter w/ 50mm thread length, 6mm diameter w/ 30mm thread length, 6mm diameter w/ 40mm thread length, and 6mm diameter w/ 50mm thread length.

K-wires

The wires are offered in the following sizes: 400mm smooth, 400mm olive, and 530mm olive. K-wire washer in 1 size

Single Use Components:

Rings

Full Ring- The full ring is offered in the following sizes: 140mm, 160mm, 180mm, and 200mm.

Half Ring- The half ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.

5/8" Ring- The 5/8" ring is offered in the following sizes: 140mm, 160mm, 180mm, 200mm, and 220mm.

Cross bar - Two lengths

Foot Plates

The foot plate is offered in the following sizes: 140mm, 160mm, and 180mm.

Struts

Struts are offered in the following lengths: long (180-230mm), medium (140-180mm), and short (95-140mm).

Rocker bottom

K-wire holding bolts

Half pin clamps

Extensions:

Threaded rods (20mm through 200mm, hex posts (20mm through 60mm), cubes (1, 2, 3, and 4 hole)

Miscellaneous components:

Washers, nuts, bolts (10mm through 18mm), universal joint, slotted posts ( small and large), and plates ( straight and twisted).

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Reusable Instruments: Wire tensioner Wrenches Wire cutters Wire Benders AO adapters Holding and alignment Blocks Drill guide assembly Drills Provisional Alignment Guides

Materials:

The implants in the Integra External Fixation system are half-pin bone screws and wires and are manufactured from 316L ASTM F138 stainless steel. The rings and footplates are manufactured from anodized aluminum alloy. The wire/half-pin bone screw stopper coin is manufactured from silicone rubber. The rockerbottom frame component is manufactured from Radel plastic, aluminum, and silicone rubber. The reusable instrumentation is manufactured from biocompatible materials, including stainless steel, aluminum, and carbide tips.

Intended Use:

The Integra® External Fixation System is a single-use modular external fixator consisting of rings, half-pin bone screws, wires, and struts and is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.

Indications for Use:

Correction of deformity
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures
· Fusions and replantations of the foot
Charcot reconstruction and Lisfranc dislocations
Ankle distraction (arthrodiastasis)

Technological Characteristics:

There are no technological characteristics that raise new issues of safety or effectiveness.

Assessment of performance data:

The performance of the Integra External Fixation System was verified to be statistically equivalent to that of the predicate device. The predicate construct and Integra External Fixation System construct were tested both dynamically and statically. The stiffness of the 2 systems was

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compared and was statistically equivalent. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.

Legally Marketed Predicate Device:

Biomet® Vision™ FootRing™ System (K093057)

Predicate Indications for Use:

The Biomet® Vision™ FootRing™ System ( K093057) is indicated for

1. Leg lengthening;
1. Osteotomies;
1. Joint arthrodesis;
1. Fracture fixations:
1. Other bone conditions amenable to treatment by the use of external fixation treatment modality:
1. Correction of deformity;
1. Revision procedure where other treatments or devices have been unsuccessful;
1. Bone reconstruction procedures;
1. Fusions and replantations of the foot
1. Charcot foot reconstruction and Lisfranc dislocation;
1. Ankle distraction (arthrodastasis);

Purpose:

The purpose of this Traditional 510(k) submission is to gain clearance for the Integra External Fixation System.

Based upon the similarities of the Integra External Fixation System and the predicate devices studied, the safety and effectiveness of the Integra External Fixation System is substantially equivalent to the predicate devices referenced.

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.