The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DD), neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.

Device Description

The Omnia Medical Coupler-C Anterior Cervical Plate system includes plates, screws, and an instrument set used to insert the implants. The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and to implant the device.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Omnia Medical Coupler-C Anterior Cervical Plate. This document primarily focuses on establishing "substantial equivalence" of the new device to existing legally marketed predicate devices, rather than a diagnostic device that requires clinical performance studies based on acceptance criteria for accuracy metrics.

Therefore, the provided text does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the performance of a diagnostic or AI-powered device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing which demonstrates the device's physical properties are comparable to legally marketed predicate devices.

Here's the relevant information that can be extracted:

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

The document states:
"Substantial equivalence is supported by the results of mechanical testing, including static and dynamic compression bending, and static torsion per ASTM F1717. Results support that the subject device has demonstrated substantial equivalence."

Acceptance Criteria: Demonstrated "substantial equivalence" based on mechanical testing according to ASTM F1717 guidelines. (The specific numerical criteria for static and dynamic compression bending, and static torsion are not detailed in this document but would be defined by ASTM F1717 and the comparison to predicate devices.)

Reported Device Performance:

Static and dynamic compression bending per ASTM F1717: Results support "substantial equivalence."
Static torsion per ASTM F1717: Results support "substantial equivalence."

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical units of the device subjected to mechanical testing, not a dataset of patient images or clinical data. The provenance of these physical samples is not specified but would typically be manufactured units of the Omnia Medical Coupler-C Anterior Cervical Plate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic device is not relevant for this type of mechanical testing.

4. Adjudication method for the test set: Not applicable.

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 a spinal implant device, not a diagnostic imaging device with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used: Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning or diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (a spinal implant), not a software or diagnostic device. Therefore, the questions related to acceptance criteria for diagnostic accuracy, study design for clinical performance, expert adjudication, or AI performance are not relevant to this specific K223321 submission. The "acceptance criteria" and "study" refer to mechanical testing validating the structural integrity and performance compared to existing devices.

Summary

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March 13, 2023

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

Omnia Medical, LLC % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K223321

Trade/Device Name: Omnia Medical Coupler-C Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 17, 2023 Received: January 19, 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 FDA

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) K223321

Device Name Omnia Medical Coupler-C Anterior Cervical Plate

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)
□ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

Submitted By:	Omnia Medical, LLC6 Canyon Road Suite 300Morgantown, WV 26508
Date:	01/17/2023
Contact Person:	Jennifer Palinchik, President
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
Device Trade Name:	Omnia Medical Coupler-C Anterior Cervical Plate
Common Name:	Spinal Intervertebral Body Fixation Orthosis
Device Classification Name:	Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	KWQ
Primary Predicate Device:	K143626- Zimmer Spine Invizia Anterior Cervical Plate SystemThe primary predicate device has never been subject to a recall.
Additional Predicates:	K113329 K2M Pyrenees Cervical Plate SystemK183056 Globus ASSURE Anterior Cervical Plate SystemK182489 Solco 4CIS® Pinehurst Anterior Cervical Plate System

Device Description:

Indications for Use:

The Ommia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DDD, neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.

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Summary of Technological Characteristics:

The Omnia Medical Coupler-C Anterior Cervical Plate and the predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use ●
Materials .
Dimensions
Function ●

Item	Omnia Coupler Cervical Plate	Zimmer InViZia CervicalPlate (K143626)	Comparison
ClassificationName	Spinal Intervertebral Body FixationOrthosis	Spinal Intervertebral BodyFixation Orthosis	Equivalent
Regulation	21 CFR 888.3060	21 CFR 888.3060	Equivalent
Product Code	KWQ	KWQ	Equivalent
Indicationsfor Use	The Omnia Medical Coupler-C AnteriorCervical Plate is in indicated for use intemporarily stabilizing the anterior spinefrom C2 to T1 during the developmentof cervical spinal fusion in patients withdegenerative disc disease (DDD, neckpain of discogenic origin withdegeneration of the disc confirmed byhistory and radiographic studies),spondylolisthesis, trauma (i.e., fractureor dislocation), spinal stenosis,deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumors,pseudoarthrosis, or failed previousfusion.	The inViZia® AnteriorCervical Plate System isdesigned for anteriorinterbodyscrew fixation of thecervical spine at levels C2-T1.The inViZia® AnteriorCervical Plate System isindicated for use in thetemporarystabilization of the anteriorspine during thedevelopment of cervicalspinal fusions in patientswith degenerative discdisease (as defined by neckpain of discogenicorigin with degeneration ofthe disc confirmed bypatient history andradiographicstudies), trauma (includingfractures), tumors,deformity (defined askyphosis,lordosis or scoliosis),pseudoarthrosis and/orfailed previous fusions.	Equivalent
Description	The Omnia Medical Coupler-C AnteriorCervical Plate system includes plates	The Zimmer SpineAnterior Cervical and	Equivalent

	in the surgical insertion of the implants.The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate in order to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and in placement of the device.	Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths.
Plate Sizes	1 Level: 21-33mm, 2mm increments2 Level: 33-55mm, 2mm increments3 Level: 51-78mm, 3mm increments4 Level: 73-105mm, 4mm increments	1 Level: 18-34mm, 2mm increments2 Level: 34-54mm, 2mm increments3 Level: 48-72mm, 3 mm increments4 Level: 68-92mm, 4mm increments	Equivalent
Plate length(hole-to-hole)	1 Level: 12-24mm, 2mm increments2 Level: 24-36mm, 2mm and 3mm increments3 Level: 42-69mm, 3mm increments4 Level: 64-96mm, 4mm increments	NA	Equivalent
PlateThickness	2mm	<2mm	Equivalent
Screw Sizes	Diameters: 4.0 and 4.5mmLengths: 8-18mm, 2mm increments	Diameters: 4.2 and 4.6 mmLengths: 12-16mm, 2mm increments	Equivalent

Table 1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems

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Mechanical Testing:

Substantial equivalence is supported by the results of mechanical testing, including static and dynamic compression bending, and static torsion per ASTM F1717. Results support that the subject device has demonstrated substantial equivalence.

Conclusion:

Based on the indications for use, technological characteristics, and 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.