The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.

Device Description

The CYGNUS™ Anterior Cervical Plate System consist of implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. and instrumentation manufactured from stainless steel per ASTM F899. The Anterior Cervical Plate Devices are offered in four configurations of various sizes to accommodate different patient anatomy. The implants will be provided non-sterile and are intended for single use only.

AI/ML Overview

This is a 510(k) premarket notification for the CYGNUS™ Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis. As such, the information provided focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical studies involving human patients or complex AI algorithm performance.

Therefore, many of the requested categories related to AI models, human reader performance, and detailed clinical study design will not be present in this document.

Here's the information that can be extracted or deduced from the provided text:

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

The document refers to "preclinical testing" based on a standard, and concludes substantial equivalence. It does not provide a table with specific acceptance criteria values and reported performance values for each criterion. It broadly states:

	Acceptance Criteria (implied)	Reported Device Performance
Mechanical Performance	Met the requirements of ASTM F1717-15 for static and dynamic compression bending and static torsion. The device should perform equivalently or better than predicate devices to ensure safety and effectiveness for its intended use.	"The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance." Specific numerical results are not provided in this summary.
Material Composition	Implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136; instrumentation from stainless steel per ASTM F899.	Conforms to specified ASTM standards for materials.
Indications for Use	Must be substantially equivalent to predicate devices.	The Indications for Use for the CYGNUS™ system are listed and are deemed substantially equivalent to predicate devices.
Technological Characteristics	Must be substantially equivalent to predicate devices.	Deemed substantially equivalent.
Labeling	Must be substantially equivalent to predicate devices.	Deemed substantially equivalent.
Safety and Efficacy	Should not raise any new questions of safety or efficacy.	"The CYGNUS™ Anterior Cervical Plate System does not raise any new questions of safety or efficacy when compared to the predicate device(s)."

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

This device is not an AI/software device that typically uses test sets of data (like images or patient records). The "test set" here refers to the physical devices tested.

Test Set Description: The device itself (CYGNUS™ Anterior Cervical Plate System) was tested.
Sample Size: Not explicitly stated as a number of individual units tested, but multiple configurations and sizes were likely tested to cover various design parameters. The text mentions the system "are offered in four configurations of various sizes."
Data Provenance: The testing was preclinical mechanical testing performed according to ASTM standards. It's not human patient data, so "country of origin" and "retrospective/prospective" are not applicable in the clinical trial sense.

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)

Not applicable. As this is a mechanical device, ground truth for its performance is established through standardized engineering testing (ASTM F1717-15), not expert interpretation of clinical data.

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

Not applicable. Mechanical testing does not involve adjudication by experts in the context of clinical data interpretation. The results are typically objective measurements from testing machines.

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 is not an AI-powered device, and no MRMC study was conducted.

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

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

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

The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F1717-15), which define acceptable mechanical properties and performance under various loading conditions (static and dynamic compression bending, static torsion). The "truth" is whether the device meets these engineering specifications and performs equivalently to legally marketed predicate devices.

8. The sample size for the training set

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

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

Not applicable. No training set was used.

Summary

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May 9, 2019

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

Re: K190666

Trade/Device Name: CYGNUS™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 13, 2019 Received: March 15, 2019

Dear Mr. 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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,

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190666

Device Name CYGNUSTM Anterior Cervical Plate 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

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	March 13, 2019
IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type	CYGNUS™ Anterior Cervical Plate SystemSpinal Intervertebral Body Fixation Orthosis21 CFR 888.3060Class IIKWQTraditional 510(k)
V. PREDICATE DEVICE	Primary:Synthes CSLP System (K000742)Additional:EBI Anterior Cervical Plate (K001794)Aesculap ABC Plate (K974706)Reference:

MiRus Atlas Plating System (K190415)

VI. DEVICE DESCRIPTION

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VII. INDICATIONS FOR USE

The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7)Pseudarthrosis; (8) Failed previous fusions.

VIII. PREDICATE DEVICE COMPARISON

The documentation provided shows that the CYGNUS™ Anterior Cervical Plate System is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics and labeling.

IX. PERFORMANCE DATA

Static and dynamic compression bending and static torsion were performed adhering to ASTM F1717-15. The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance.

X. CONCLUSONS

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

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.