The Integra® External Fixation System is an external fixation device 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. The modifications to the device include material and minor design updates to the Universal Wire Fixation Bolt and Slotted Posts which do not affect the safety and effectiveness of the device. An update was also made to the position of the olive on the 530mm olive wire. Lastly, the sharpness of the olive wire and k-wire were modified.

AI/ML Overview

The provided text describes a 510(k) submission for the Integra® External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that establishes acceptance criteria for a novel device's performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this specific document. This document details modifications to an existing device and confirms that these modifications do not negatively impact its safety and effectiveness compared to the predicate.

However, I can extract information related to the performance comparison and the "acceptance criteria" as defined by substantial equivalence to the predicate device.

Here's a breakdown of the available information based on your request:

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

For a 510(k) submission, the "acceptance criteria" for the modified device (Integra® External Fixation System K160830) is that its performance should be statistically equivalent to the predicate device (Integra® External Fixation System K140463) for the specific elements that were modified.

Acceptance Criteria (for modified components)	Reported Device Performance (K160830)
Stiffness statistically equivalent to predicate	Stiffness was statistically equivalent to predicate.
Acceptable Torsional Strength	A torsional strength test was performed. (Result implicitly positive, otherwise substantial equivalence would be denied).
Acceptable Static Wire Retention	A static wire retention test was performed. (Result implicitly positive).
Acceptable Dynamic Wire Retention	A dynamic wire retention test was performed. (Result implicitly positive).
Olive wire position validation	Validation performed, no further verification needed.
Wire sharpness validation	Validation performed, no further verification needed (no effect on part strength).

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

Sample Size: The document does not specify the exact sample sizes used for the dynamic, static, and torsional tests. It mentions "constructs were tested" implying multiple samples of the modified components.
Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer as part of their design control and validation processes. It is prospective testing aimed at proving specific performance characteristics of the modified components.

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)

This is not applicable. The "ground truth" here is the physical and mechanical performance of the device components, measured through engineering tests, not an interpretation by medical experts. The evaluation is based on objective measurements and comparison to predefined engineering standards or the performance of the predicate.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are quantitative and typically assessed against pre-defined engineering thresholds or comparative data from the predicate device.

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 device is an external fixation system (a physical medical device), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant here.

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

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

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

The "ground truth" for the performance assessment of the modified components is their measured mechanical properties and physical characteristics (e.g., stiffness, tensile strength, wire retention forces, olive position, sharpness). These are objective engineering measurements compared against the predicate device's corresponding properties.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 6, 2016

Ascension Orthopedics % Ms. Jayana Kenana Regulatory Associate Integra LifeSciences 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K160830

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: June 7, 2016 Received: June 8, 2016

Dear Ms. Kenana:

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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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/ResourcesforYou/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,

Vincent J. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Integra® External Fixation System

Indications for Use (Describe)

· 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)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510k Summary

Device Trade Name:	Integra® External Fixation System
Date:	March 23, 2016
Sponsor:	Integra® LifeSciences Corporation

Contact Person: Integra Life Sciences Corp Jayana Kenana Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, NJ 08536 609-936-2657 jayana.kenana@integralife.com

Manufacturer:

Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 609-936-2657 jayana.kenana@integralife.com

Common Name:	External Fixation Device
Device Classification:	Class II
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories (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)

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Miscellaneous components:

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

Reusable Instruments:

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

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:

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)

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 (Integra External Fixation System, K140463). The

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material change done to the wire fixation bolt on the Integra External Fixation System construct were tested both dynamically and statically. The performance testing done on the wire fixation bolt was applied to the material change of the slotted posts to 17-4 SS. The stiffness of the 2 systems was compared and was statistically equivalent. A torsional strength test, static wire retention test, and dynamic wire retention test was performed. Validation was performed on the shift of position of the olive on the olive wire and it was concluded that further verification testing was not needed. Validation was performed on the sharpness of the wires and because this modification has no effect on part strength no further verification testing was performed.

Legally Marketed Predicate Device:

Integra® External Fixation System (K140463)

Predicate Indications for Use:

The Integra® External Fixation System (K140463) is indicated 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)

Purpose:

The purpose of this Special 510(k) submission is to gain clearance for the Integra® External Fixation System device modifications including the material change and design updates performed on the Universal Wire Fixation Bolt and Slotted Post. The submission also introduces the minor modifications to the olive location on the olive wire and the sharpness on the olive wire and k-wire.

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 device 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.