The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening

Device Description

The Cardinal Health External Fixation System consists of rod-to pin clamps, rod-to-rod clamps, rods, pins. Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (316L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber reinforced epoxy. The Cardinal Health External Fixation System is provided non-sterile.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance in a study, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document is a 510(k) premarket notification for the "Cardinal Health External Fixation System," which is a regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria.

Here's what the document does provide:

Device Name: Cardinal Health External Fixation System
Indications for Use: Treatment for long bone and pelvic fractures requiring external fixation, including stabilization of soft tissues, polytrauma, pelvic fractures, arthrodeses/osteotomies, neutralization of fractures, non-unions, intra-operative reductions, and leg lengthening.
Predicate Device: Emerge External Fixation System (K140675)
Performance Data (Mechanical Testing): The device underwent testing related to MRI safety and compatibility in accordance with ASTM standards (F2182-11a, F2052-06, F2213-11). It states that the device is "safe and compatible in the MR environment as an 'MR Conditional' device." It also mentions that the predicate device included performance testing per ASTM F1541-02 (2001).
Conclusion on Performance: "In all instances, the External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device." However, the specific acceptance criteria themselves for the functional performance (beyond MRI safety) are not detailed in this document.
Substantial Equivalence Basis: Intended use, basic design, materials, sizing, and performance.

Therefore, I cannot fulfill your request for the specific table, sample sizes, expert details, adjudication methods, MRMC study information, or standalone algorithm performance data as this type of information is not present in the provided text. The document describes a regulatory filing based on mechanical testing for MRI compatibility and comparison to a predicate, not a clinical or performance study with detailed acceptance criteria for a medical device's efficacy or accuracy in diagnosis/treatment.

Summary

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

April 29, 2015

Cardinal Health Ms. Tatyana Bogdan Director, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K150579

Trade/Device Name: Cardinal Health 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: March 5, 2015 Received: March 9, 2015

Dear Ms. Bogdan:

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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Page 2 - Ms. Tatyana Bogdan

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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/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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150579

Device Name

Cardinal Health External Fixation System

Indications for Use (Describe)

The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures
· Polytrauma/multiple orthopedic trauma
· Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
· Arthrodeses and osteotomies with soft tissue problems; failures of total joints
· Neutralization of fractures stabilized with limited internal fixation
· Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
· Unilateral rectilinear bone segment transport or leg lengthening

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

☒ Research Use Only (21 CFR 201.3 Subject to Section 510(k))
☐ Over-The-Counter Use Only (21 CFR 201.3 Subject to Section 510(k))

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

510(k) Number: K150579

Submitter's Name, Address, Telephone Number:

Cardinal Health 1500 Waukegan Road Waukegan IL 60085

Contact Person:

Tatyana Bogdan Director, Regulatory Affairs Phone: 847.887.2325 Facsimile: 847.785.2461 Email: tatyana.bogdan-curvin@cardinalhealth.com

Prepared by:

Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street, NW, 12th Floor Washington, DC 20005 202.552.5800

Date Prepared: March 5, 2015

Device Name: Cardinal Health External Fixation System

Device Classification: Class II; 21 CFR 888.3030

Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

Product Code: KTT

Device Description:

Indications for Use:

The Cardinal Health External Fixation is intended for use to provide treatment for long bone

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and pelvic fractures that require external fixation.

The system can be used for:

. Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma ●
Vertically stable pelvic fractures. or as a treatment adjunct for vertically unstable pelvic ● fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints ●
Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening

Predicate Device:

Emerge External Fixation System (K140675)

Performance Data:

Testing was performed on the Cardinal Health External Fixation System in accordance with ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, ASTM F2052-06, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment, and ASTM F2213-11, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment. Results demonstrate that the Cardinal Health External Fixation System is safe and compatible in the MR environment as an "MR Conditional" device. The predicate 510(k), K140675, included performance testing conducted per ASTM F1541-02 (2001). In all instances, the External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.

Substantial Equivalence:

The Cardinal Health External Fixation System is substantially equivalent to the legally marketed predicate based on intended use, basic design, materials, sizing and performance.

Regulation Number and Section

N/A