The AURORA™ Screw System is a bone screw system consisting of solid and cannulated screws for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist. The screws are available in different diameters from Ø2.7mm to Ø7.5mm, are solid or cannulated with lengths ranging from 18mm to 160mm. All screws are manufactured from Ti-6AI-4V ELI alloy (ASTM F136-13). Optional washers are available for certain screws; the washers are also made from Ti-6AI-4V ELI alloy (ASTM F136-13). The screws and washers are intended to be implanted until bone healing. Implants are single use and the system is provided non-sterile.

AI/ML Overview

This document is a 510(k) Premarket Notification from MiRus, LLC to the FDA for their AURORA™ Screw System. It seeks to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, the AURORA™ Screw System is a medical device, specifically a bone screw system, not an AI/ML powered device. Therefore, the questions related to acceptance criteria and studies for AI/ML device performance (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this submission.

The acceptance criteria and performance data for this type of device are primarily focused on mechanical testing and engineering analysis to demonstrate the device's physical properties and safety.

Here's the information that can be extracted from the provided document regarding acceptance criteria and performance data for the AURORA™ Screw System:

Acceptance Criteria and Device Performance (Non-AI Device)

Acceptance Criteria Category	Description	Reported Device Performance/Validation Method
Mechanical Performance	The device must meet the mechanical performance requirements for bone fixation fasteners to ensure adequate strength and durability for its intended use (repair of fractures, fusions, and osteotomies of bones and bone fragments).	Mechanical testing (ASTM F543) was performed and submitted.
Biocompatibility	The materials used (Ti-6AI-4V ELI alloy) must be biocompatible for implantation in the human body.	Not explicitly detailed as "acceptance criteria" but implied by the use of ASTM F136-13 compliant material, which is a standard for biocompatible titanium alloy.
Substantial Equivalence	The device must be demonstrated as substantially equivalent to legally marketed predicate devices in terms of intended use, indications for use, materials, technological characteristics, and labeling, without raising new questions of safety or efficacy.	Predicate device comparison and Engineering Analysis were conducted. The conclusion states that the device "does not raise any new questions of safety or efficacy when compared to the predicate device(s)" and "is substantially equivalent in mechanical performance, indications for use, intended use, technological characteristics, materials and labeling."
Manufacturing Quality	The device must be manufactured under good manufacturing practice (GMP) requirements (21 CFR Part 820).	Not part of the performance data section, but a general regulatory requirement that MiRus, LLC must comply with (as stated in the FDA letter).
Sterility	(Implied) If provided sterile, it must meet sterility requirements. However, the document states "implants are single use and the system is provided non-sterile."	Not applicable as the system is provided non-sterile.

Since this is a non-AI/ML medical device submission, the following AI/ML specific questions are not addressed by the provided document:

Sample sizes used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the 510(k) premarket notification for a traditional bone screw system, not an AI/ML-powered device. The reported performance data focused on mechanical testing (ASTM F543) and engineering analysis to demonstrate substantial equivalence to predicate devices, which is standard for this class of non-AI medical devices.

Summary

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December 18, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.

MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway SE, Suite 108 Marietta, Georgia 30067

Re: K182989

Trade/Device Name: AURORA™ Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 26, 2018 Received: October 29, 2018

Dear Jordan Bauman:

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,

Image /page/1/Figure/5 description: The image shows a digital signature. The signature is for Jesse Muir -S. The date of the signature is December 18, 2018, and the time is 14:54:04 -05'00'.

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

Enclosure

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5. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known)

K182989

Device Name

AURORA™ Screw System

Indications for Use (Describe)

The AURORA™ Screw System is intended to aid in the repair of fractures, fusions and osteotomies of bones and bone fraqments.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17) Page 1 of 1

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6. 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus™™, LLC2150 Newmarket Parkway SESuite 108Marietta, Georgia 30067Tel: (678)-324-6272Fax: (678) 401-5607
II. OFFICIAL CORRESPONDENT	Jordan BaumanDirector of Regulatory Affairs and QualityMiRus™™, LLC2150 Newmarket Parkway SESuite 108Marietta, Georgia 30067Tel: (678)-324-6272Fax: (678) 401-5607
III. DATE PREPARED	October 26, 2018
IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	AURORA™ Screw SystemFixation Bone Screw System21 CFR §888.3040: Smooth or threadedmetallic bone fixation fastenerClass IIHWCTraditional 510(k)
V. PREDICATE DEVICE	Osteomed Cannulated Screw System (K151021 -primary predicate)MAXTORQUE™ Screw System (K131324)MAXTORQUE™ MINI Cannulated Screw System(K082574)CSS Cannulated Screw System (K060428)

VI. DEVICE DESCRIPTION

The screws are available in different diameters from Ø2.7mm to Ø7.5mm, are solid or cannulated with lengths ranging from 18mm to 160mm. All screws are manufactured from

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Ti-6AI-4V ELI alloy (ASTM F136-13). Optional washers are available for certain screws; the washers are also made from Ti-6AI-4V ELI alloy (ASTM F136-13).

The screws and washers are intended to be implanted until bone healing. Implants are single use and the system is provided non-sterile.

VII. INDICATIONS FOR USE

The AURORA™ Screw System is intended to aid in the repair of fractures, fusions and osteotomies of bones and bone fragments.

VIII. PREDICATE DEVICE COMPARISON

The documentation provided shows that the MiRus™ AURORA™ Screw System is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics and labeling.

IX. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Mechanical testing (ASTM F543) ●
Engineering Analysis .

X. CONCLUSONS

The MiRus™ AURORA™ Screw System does not raise any new questions of safety or efficacy when compared to the predicate device(s). The AURORA™ Screw System has demonstrated that it is substantially equivalent in mechanical performance, indications for use, intended use, technological characteristics, materials and labeling to legally marketed predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.