The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal Stenosis .
Trauma (i.e. fracture or dislocation) .
Deformity or curvatures (including scoliosis, kyphosis, or lordosis) .
. Spinal Tumors
Pseudoarthrosis or failed previous fusion .
Spondylolisthesis .
Decompression of the spinal following total or partial cervical vertebrectomy .

Device Description

The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The CACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the DeGen Medical Cyclops™ Anterior Cervical Plate System. It describes the device's intended use, technological characteristics, and non-clinical performance testing. However, this document does not contain information about an AI/ML-based medical device. Therefore, it is not possible to describe acceptance criteria or a study proving an AI/ML device meets those criteria from this text.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, function, and mechanical performance rather than clinical performance or AI algorithm assessment.

Therefore, I cannot fulfill the request as the core information regarding an AI/ML device's acceptance criteria, performance study details, ground truth establishment, or human-in-the-loop analysis is absent from the provided text.

Summary

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August 30, 2019

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DeGen Medical INC % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K191786

Trade/Device Name: CyclopsTM 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: July 31, 2019 Received: August 1, 2019

Dear Linda Braddon:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 RPJ

Ronald Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices 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) K191786

Device Name

Cyclops™ Anterior Cervical Plate System

Indications for Use (Describe)

· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal Stenosis .
Trauma (i.e. fracture or dislocation) .
Deformity or curvatures (including scoliosis, kyphosis, or lordosis) .
. Spinal Tumors
Pseudoarthrosis or failed previous fusion .
Spondylolisthesis .
Decompression of the spinal following total or partial cervical vertebrectomy .

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image features the logo for Degen Medical. The logo consists of a stylized graphic above the text "DEGEN MEDICAL". The graphic is composed of three curved lines that converge at a point on the left and terminate in circles on the right. The lines are blue, and the circles are solid blue. The text "DEGEN" is in a bold, sans-serif font, and "MEDICAL" is in a smaller, sans-serif font below it.

510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical Cyclops Anterior Cervical Plate (CACP) is provided below.

Date	July 2, 2019
Sponsor	DeGen Medical, Inc.1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
Trade Name	Cyclops™ Anterior Cervical Plate System
Common Name	Spinal Intervertebral Body Fixation Orthosis
Code -Classification	KWQ21 CFR 888.3060: Class II
Primary Predicate	K150759 Hyper-C Anterior Cervical Plate System
Additional Predicates	K971883 Synthes Small Stature Anterior Cervical Locking Plate SystemK030866, K031276, K926453, K945700 Synthes CSLPK052292 X-Spine Spider Cervical PlateK013877, K121658 Orthofix Hallmark Anterior Cervical Plate SystemK080646, K133518 Biomet Maxan Anterior Cervical Plate System
Device Description	The DeGen Medical Cyclops™ Anterior Cervical Plate Systems (CACP) consists of cervicalplates and bone screws. All implants are intended to provide stabilization of the cervicalvertebrae. The CACP provides anterior fixation from either fixed or variable angleconstruct in self-tapping or self-drilling bone screw options. The system is provided non-sterile and is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
Indications for Use	The DeGen Medical Cyclops™ Anterior Cervical Plate system is intended for use as anaid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™Anterior Cervical Plate system is intended for anterior intervertebral screw fixation ofthe cervical spine at levels C2 to T1. The system is indicated for temporary stabilizationof the anterior spine during the development of cervical spine fusions in patients withfollowing indications:Degenerative Disc Disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies) Spinal Stenosis Trauma (i.e. fracture or dislocation) Deformity or curvatures (including scoliosis, kyphosis, or lordosis) Spinal Tumors Pseudoarthrosis or failed previous fusion Spondylolisthesis Decompression of the spinal following total or partial cervical vertebrectomy
TechnologicalCharacteristics	As was established in this submission, the subject Cyclops™ Anterior Cervical PlateSystem (CACP) is substantially equivalent to other predicate devices cleared by the FDAfor commercial distribution in the United States. The subject device was shown to besubstantially equivalent and has the same technological characteristics to its predicatedevices through comparison in areas including design, intended use, materialcomposition, function, and range of sizes.
Non-ClinicalPerformance TestingConclusion	Non-clinical testing was performed to demonstrate the DeGen Medical Cyclops™Anterior Cervical Plate System (CACP) is substantially equivalent to other predicatedevices in accordance with "Guidance for Industry and FDA Staff, Guidance for SpinalSystem 510(k)s", May 3, 2004. The following tests were performed:Static and dynamic compression testing per ASTM F1717 Static torsion testing per ASTM F1717 Screw strength via ASTM F543 Push-out testing for Screws The results of these studies show the subject DeGen Medical Cyclops™ Anterior CervicalPlate System (CACP) meets or exceeds the performance of the predicate devices, andthe device was therefore found to be substantially equivalent.
SubstantialEquivalence Summary(Conclusion)	Based on the indications for use, technological characteristics, performance testing, andcomparison to predicate devices, the subject DeGen Medical Cyclops™ Anterior CervicalPlate System (CACP) has been shown to be substantially equivalent to legally marketedpredicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for Degen Medical. The logo features a stylized blue graphic above the words "DEGEN" and "MEDICAL", which are stacked on top of each other. The graphic consists of three curved lines, each with a blue circle at the end, resembling a stylized representation of medical technology or innovation.

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.