The Athena II Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena II Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

Device Description

The Athena II Cervical Plate System is an anterior cervical plating system offered pre-lordosed with large graft visibility windows intended for anterior screw fixation to the cervical spine. The components of the Athena II Cervical Plate System are manufactured from titanium alloy (Ti-6Al-4V) as described in ASTM F136. The Athena II Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.

AI/ML Overview

The provided text is a 510(k) summary for the Athena II Cervical Plate System. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, this document does not describe a study involving an algorithm's performance, human reader studies, or the establishment of ground truth in a medical imaging context.

The information provided pertains to a mechanical medical device (a cervical plate system) and its structural performance, not an AI/ML-driven diagnostic or assistive device. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document discusses pre-clinical testing for the Athena II Cervical Plate System, which focuses on the mechanical integrity and performance of the physical implant itself.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that pre-clinical testing was performed per ASTM F1717-13. The reported performance is a comparison to predicate devices.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Static Compression Bending	Equivalence to predicate devices (ASTM F1717-13)	Substantially equivalent to predicates
Static Torsion	Equivalence to predicate devices (ASTM F1717-13)	Substantially equivalent to predicates
Static Tension	Equivalence to predicate devices (ASTM F1717-13)	Substantially equivalent to predicates
Dynamic Compression Bending to 5MM cycles	Equivalence to predicate devices (ASTM F1717-13)	Substantially equivalent to predicates
Note: The specific numerical acceptance criteria from ASTM F1717-13 itself are not detailed in this summary, but the general principle is "substantial equivalence" to the predicates based on this standard.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a study of an AI/ML device using a test set of medical data. The testing involves mechanical bench testing of physical medical devices. The "test set" would refer to the number of physical samples tested, which is not specified but is typically much smaller than for an AI study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert review of medical images or clinical outcomes, is not relevant to the mechanical testing of a cervical plate.

4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert interpretations of medical data, which is not what this document describes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is not an MRMC study. It is mechanical testing of a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices and the physical properties determined through the tests (e.g., load-bearing capacity, fatigue resistance). This is established via standardized testing protocols (ASTM F1717-13).

8. The Sample Size for the Training Set:
Not applicable. There is no training set for an AI/ML algorithm in this document.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for an AI/ML algorithm in this document.

In summary: The provided document is a 510(k) clearance summary for a spinal implant, focusing on its mechanical pre-clinical performance testing against predicate devices. It does not contain the type of information requested about AI/ML device studies or human reader performance.

Summary

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February 11, 2019

Medyssey USA Inc. % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 3851 Mossy Oak Drive Ft. Myers, Florida 33905

Re: K183409

Trade/Device Name: Athena II Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: December 6, 2018 Received: December 10, 2018

Dear Dr. Jansen:

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

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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/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.

Ronald P. Jean -S

for 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) K183409

Device Name: Athena II 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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

Page 1 of 1

entices (301)-649-6780

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510(k) Summary

Date Prepared:	December 3, 2018
Submitter:	Shawn Kim
	Medyssey USA Inc.
	1550 E. Higgins Road
	Suite 123
	Skokie, IL 60077
	847-427-0200
	888-518-9070 (fax)
Regulatory Contact:	Rich Jansen, Pharm. D.
	Silver Pine Consulting, LLC.
Product
Trade Names:	Athena II Cervical Plate System
Product Class:	Class II
Classification:	21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis
Common Name:	Cervical Plate System
Product Codes:	KWQ
Panel Code:	87

Device Descriptions:

Indications for Use:

Predicate Device(s):

The primary predicate device is the Athena Cervical Plate System (K180022). Additional predicate devices include the Vertebron Cervical Plate (K081567) and the Vectra Cervical Plate System (K050451).

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The Athena II Cervical Plate System was compared to the predicated devices in regards to:

Indications for Use
Materials
Number of levels covered
Plate Dimensions
Screw Dimensions
. Design features and technological characteristics

The Athena II Cervical Plate System is considered to be substantially equivalent to one or all of the predicate devices in all elements of comparison.

Performance Standards:

The pre-clinical testing was performed by an independent laboratory. Testing was conducted per ASTM F1717-13. Testing included:

Test	Result
Static Compression Bending	Substantially equivalent to predicates
Static Torsion	Substantially equivalent to predicates
Static Tension	Substantially equivalent to predicates
Dynamic Compression Bending to 5MM cycles	Substantially equivalent to predicates

Conclusion:

Medyssey concludes that the Athena II Cervical Plate system is substantially equivalent to the 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.