The Athena III 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, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

Device Description

The Athena III 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 III Cervical Plate System are manufactured from titanium alloy (Ti-6AI-V), as per ASTM F136. The system consists of a variety of shapes and sizes of bone plates and screws. Implant components are anodized per AMS 2487A.

AI/ML Overview

This document is a 510(k) premarket notification for the Athena III Cervical Plate System. It describes a medical device, specifically a spinal implant, and seeks to demonstrate its substantial equivalence to a previously cleared predicate device (Athena II Cervical Plate System).

The information provided does not describe an AI/ML medical device, nor does it detail acceptance criteria related to software performance, or a study involving human readers or ground truth determination as typically found in AI/ML performance evaluations. Instead, it focuses on the mechanical performance of a physical implant.

Therefore, I cannot extract the requested information using the prompt's categories, as they are tailored for AI/ML device evaluations.

Here's a breakdown of what is provided regarding acceptance criteria and the study, adapted to the context of this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category (for physical device)	Reported Device Performance
Mechanical Strength & Safety (Static Compression Bending)	Met acceptance criteria (further details in submission, not provided)
Mechanical Strength & Safety (Static Torsion)	Met acceptance criteria (further details in submission, not provided)
Mechanical Strength & Safety (Static Tension)	Met acceptance criteria (further details in submission, not provided)
Mechanical Strength & Safety (Dynamic Compression Bending)	Met acceptance criteria (further details in submission, not provided)
Material Composition	Titanium Alloy (Ti-6Al-4V) per ASTM F136 (Equivalent to predicate)
Manufacturing Processes	Equivalent to predicate
Design Features/Dimensions	Comparable to predicate (modified screw and wing plate design, but overall comparable)
Post-Processing Procedures (Sterility, Shelf-Life)	Equivalent to predicate
Indications for Use	Equivalent to predicate (anterior interbody screw fixation of the cervical spine, C3-C7 levels, for various conditions)
Intended Use & Fundamental Scientific Technology	Same as predicate

2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "a full suite of mechanical testing" but does not specify the sample size for the test articles (cervical plates and screws). The "data provenance" in this context would refer to the testing facility and conditions, which are not detailed here.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the evaluation is for mechanical performance of a physical device, not an AI/ML algorithm requiring expert-established ground truth.

4. Adjudication Method:
This is not applicable as the evaluation is for mechanical performance of a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a physical spinal implant, not an AI/ML system evaluated with human readers.

6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the mechanical properties of the Athena III Cervical Plate System were tested independently. The study involved:

Static compression bending
Static torsion
Static tension
Dynamic compression bending
These tests were performed "as per ASTM F1717," which is a standard specification for spinal plate mechanical testing.

7. Type of Ground Truth Used:
In the context of a physical device, the "ground truth" is defined by established engineering standards and material properties. For this device, the relevant "ground truth" is adherence to:

ASTM F136 (for titanium alloy material)
ASTM F1717 (for mechanical testing methods and likely performance criteria thresholds)
AMS 2487A (for anodization).

8. Sample Size for the Training Set:
This is not applicable as the device is a physical spinal implant and does not involve a training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set for a physical device. The "ground truth" for developing and validating the device is based on mechanical engineering principles, material science, and established regulatory and industry standards for spinal implants.

Summary

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March 7, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

Medyssey USA, Inc. % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd.. Suite #3 Westlake, Ohio 44145

Re: K230301

Trade/Device Name: Athena III Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 2, 2023 Received: February 3, 2023

Dear Jennifer Palinchik:

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,

Colin O'neill -S

Colin O'Neill, M.B.E. 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)

K230301

Device Name Athena III Cervical Plate System

Indications for Use (Describe)

The Athena III Cervical Plate System is interior 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), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

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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Image /page/3/Picture/0 description: The image shows the word "Medyssey" in a serif font. The word is in a dark blue color. Underneath the word are three curved lines in a lighter blue color. The lines appear to be stylized waves.

Special 510(k) Submission -Athena III Cervical Plate System Section VII - 510(k) Summary

Special 510(k) Summary

Applicant:	Medyssey USA, Inc.43176 Business Park DriveSuite 107Temecula, CA 92590 USA
Establishment Registration Number:	3008692185
Date:	February 2, 2023
Contact Person:	Jennifer Palinchik, President
Contact Email:	jpalinchik@jalexmedical.com
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
Device Trade Name:	Athena III Cervical Plate System
Device Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Device Class:	II
Reviewing Panel:	Orthopedic
Regulation Number:	888.3060
Classification Product Code:	KWQ
Predicate Device:	Medyssey USA, Inc. Athena II Cervical Plate System(K183409)

Device Description:

Indications for Use:

The Athena III 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 III Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

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Page 2 of 4 Special 510(k) Submission -Athena III Cervical Plate System Section VII – 510(k) Summary

K230301

Description of Modifications:

The Medyssey Athena III Cervical Plate System is an updated 3rd generation version of a legally marketed previous generation of the device, the Athena II Cervical Plate System. The purpose of this submission is for Medyssey to obtain clearance for design changes that include modification of screw design and a modified wing plate design. Table 7.1 below displays a visual comparison of the modified subject device consisting of the cervical plate and screw alongside the predicate device (not to scale). There were no changes to material or sterilization parameters. These changes and relevant risks are discussed in greater detail within this submission.

Subject Device:Athena III CervicalPlate System	Predicate Device:Athena II CervicalPlate System
Image: Athena III Cervical Plate System and screw	Image: Athena II Cervical Plate System and screw

Table 7.1: Device Comparison

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Special 510(k) Submission -Athena III Cervical Plate System Section VII – 510(k) Summary

Summary of Technological Characteristics:

The Athena III Cervical Plate System and the predicate have the same intended use and fundamental scientific technology. Table 7.2 below outlines a tabular comparison of the modified device and the predicate Athena II Cervical Plate System to evaluate any differences in characteristics and features that may impact safety or effectiveness.

	Modified Subject Device	Predicate Device	Comparison
Trade Name	Athena III Cervical Plate System	Athena II Cervical Plate System	Equivalent
Manufacturer	Medyssey	Medyssey	Equivalent
ClassificationName	Spinal Intervertebral BodyFixation Orthosis	Spinal Intervertebral BodyFixation Orthosis	Equivalent
510(k)Number	n/a	K183409	Equivalent
Product Code	KWQ	KWQ	Equivalent
RegulationNumber	888.3060	888.3060	Equivalent
RegulationMedicalSpecialty	Orthopedic	Orthopedic	Equivalent
Materials	Titanium Alloy (Ti6AL4VELI)	Titanium Alloy (Ti6AL4VELI)	Equivalent
Indications forUse	The Athena Cervical III PlateSystem is intended for anteriorinterbody screw fixation of thecervical spine. The system isindicated for use in thetemporary stabilization of theanterior spine during thedevelopment of a solid spinalfusion in patients withdegenerative disc disease (asdefined by neck pain ofdiscogenic origin withdegeneration of the discconfirmed by patient history andradiographic studies), trauma(including fractures), tumors,deformity (defined as kyphosis,lordosis, or scoliosis),pseudoarthrosis, and/or failedprevious fusions. The Athena IIICervical Plate System can beimplanted in the sub-axialcervical spine from C3 throughC7 levels.	The Athena II Cervical PlateSystem is intended for anteriorinterbody screw fixation of thecervical spine. The system isindicated for use in thetemporary stabilization of theanterior spine during thedevelopment of a solid spinalfusion in patients withdegenerative disc disease (asdefined by neck pain ofdiscogenic origin withdegeneration of the discconfirmed by patient historyand radiographic studies),trauma (including fractures),tumors, deformity (defined askyphosis, lordosis, orscoliosis), pseudoarthrosis,and/or failed previous fusions.The Athena II Cervical PlateSystem can be implanted in thesub-axial cervical spine fromC3 through C7 levels.	Equivalent

Table 7.2: Comparison of Subject and Predicate Device

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Image /page/6/Picture/1 description: The image shows the word "Medysey" in a bold, sans-serif font. The word is in a dark blue color. Underneath the word are three curved lines, also in dark blue, that appear to be stylized waves. The overall design is simple and clean, with a focus on the text and the wave-like graphic element.

Special 510(k) Submission -Athena III Cervical Plate System Section VII - 510(k) Summary

	Modified Subject Device	Predicate Device	Comparison
DeviceDescription	The Athena III Cervical PlateSystem is an anterior cervicalplating system offered pre-lordosed with large graftvisibility windows intended foranterior screw fixation to thecervical spine. The componentsof the Athena III Cervical PlateSystem are manufactured fromtitanium alloy (Ti-6Al-4V) asdescribed in ASTM F136. TheAthena III Cervical Plate Systemconsists of a variety of shapesand sizes of bone plates andscrews. Implant components areanodized per AMS 2487A.	The Athena II Cervical PlateSystem is an anterior cervicalplating system offered pre-lordosed with large graftvisibility windows intended foranterior screw fixation to thecervical spine. The componentsof the Athena II Cervical PlateSystem are manufactured fromtitanium alloy (Ti-6Al-4V) asdescribed in ASTM F136. TheAthena II Cervical Plate Systemconsists of a variety of shapesand sizes of bone plates andscrews. Implant components areanodized per AMS 2487A.	Equivalent

These aspects of the subject device were determined to be equivalent to the previous generation of the device as the two systems compare similarly in:

Regulatory Characteristics and Intended Use/Indications for Use
Device Function/Performance
Materials and Manufacturing Processes ●
Design Features/Dimensions
. Post-Processing Procedures, including Sterility and Shelf-Life Characteristics

Mechanical Testing:

A full suite of mechanical testing was performed to evaluate performance of the modifications to the cervical plates and screws in an effort to verify strength and safety. Substantial equivalence is supported by the results of mechanical testing, including static compression bending, static torsion, static tension, and dynamic compression bending as per ASTM F1717. Results and discussion of the testing is further discussed within the submission.

Conclusion:

Based on the indications for use, technological characteristics, mechanical testing, and overall comparison with the predicate device, the subject device has demonstrated substantial equivalence.

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.