The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.

Device Description

The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a medical device's performance, nor does it detail a study proving such criteria are met in the context of AI/ML or diagnostic image analysis. Instead, the document is a 510(k) summary for the "Austin Miller External Fixation System," a surgical device used for stabilizing bones.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Intended Use: Bone stabilization for adult and pediatric patients with long bone, feet, and pelvic fractures, non-unions, periarticular fractures, infected fractures/non-unions, joint-bridging immobilization, arthrodeses, and osteotomies.
Device Description: Consists of stainless steel bone pins, composite bars, and titanium clamps.
Technological Characteristics: Similar materials, size, strength, stiffness, assembly, and adjustment methods compared to predicate devices.
Performance Data (Mechanical and MRI Safety):
- Mechanical Testing: Pin pullout and strength testing (following ASTM F1541), grip testing of clamps, and construct testing to failure. These tests aimed to show equivalence or superiority to predicate devices in terms of load-bearing capacity.
- MRI Safety Testing: Force and torque testing in magnetic fields, image distortion testing, radiofrequency induced heating simulation, and radiofrequency induced heating testing. This was done to determine safe conditions for MRI scanning with the device implanted.

Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML-based device or a study with acceptance criteria, ground truth, expert review, or sample sizes in the context of diagnostic performance.

Summary

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February 28, 2019

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Austin Miller Trauma LLC Steve Miller President 3011 Centre Oak Way Suite 102 Germantown, Tennessee 38138

Re: K181528

Trade/Device Name: Austin Miller Large 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, JDW Dated: January 31, 2019 Received: February 1, 2019

Dear Steve Miller:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Peter G.
Allen -S

Digitally signed by Peter G. Allen -S Date: 2019.02.28 23:40:02 -05'00'

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

510(k) Number (if known) K181528

Device Name Austin Miller External Fixation System

Indications for Use (Describe)

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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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

510(k) Summary

I. SUBMITTER

Austin Miller Trauma LLC 3011 Centre Oak Way, Suite 102 Germantown, TN 38138

Phone: (901) 748-2581 Fax: (901) 748-2583

Contact Person:	Steve Miller
Date Prepared:	January 31, 2019

II. DEVICE

Proprietary Name:	Austin Miller External Fixation System
Common Name:	External Fixation System
Classification Name:	Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030) and Smooth or threaded metallicbone fixation fastener (21 CFR 888.3040)
Regulatory Class:	Class II
Product Codes:	KTT and JDW/Orthopedic/87

III. PREDICATE DEVICES

. K082650, Synthes Large External Fixation, MR Conditional
K090658, Synthes Medium External Fixation, MR Conditional ●
K113383, XtraFix External Fixation System ●
K072212, Smith & Nephew Jet-X Bar System Clamps, Bars and Posts MR Cond. ●

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Austin Miller External Fixation System is intended to be used on adult or pediatric patients for stabilization of the long bones, feet, and pelvis. The most common indication is for stabilization of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures,

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infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.

VL COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The principle of operation for the subject and the predicate devices is stabilization of bones through fixation with pins clamped to an external fixation frame built with composite bars. The Austin Miller External Fixation System is similar to legally marketed predicate devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporate similar methods of assembly and adjustment.

VII. PERFORMANCE DATA

Testing was conducted following guidelines from ASTM F1541. Pin pullout and strength testing showed substantial equivalence to predicate designs. Grip testing of the clamps showed that the clamp designs have grip strength at least equivalent to the predicate designs. Construct testing to failure showed the frame was able to support the compressive load up to the limit of the test. All structural testing shows a system performance at least equivalent to the predicate devices.

Simulations and testing were conducted to determine the performance of the system in the Magnetic Resonance environment. Force and torque testing showed limited effect of the magnetic field on the device. Image distortion testing identified the size of the image artifact expected due to the device. Radiofrequency induced heating simulation determined the worst case device construct for heating testing. Radiofrequency induced heating testing demonstrated limited levels of heating with the device placed at the edge of the bore of the MR machine. The labeling has been written to inform the user of the proper conditions in which the device can be safely scanned.

VIII. CONCLUSIONS

The claim of substantial equivalence of the Austin Miller External Fixation System to the predicate devices is based on the comparison of the intended use, device description, and technological characteristics. Austin Miller Trauma LLC considers the External Fixation System to be as safe and as effective, with substantially equivalent performance to the predicate device.

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.