The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

· Pseudoarthrosis;
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
Tumors;
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· Failed Previous Fusion

Device Description

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems provide stabilization to the lumbar spine during spinal fusion. These systems include plates, screws, and an instrument set used in the surgical insertion of the implants. The implants are composed of Ti6Al4V ELI Titanium 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 the screws into place with cam screws after insertion. The plates are available in multiple lengths to allow for utilization in fusion operations across L1 to S1 of the lumbar spine. The system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. The instrumentation is used in the placement and fixing of the device.

AI/ML Overview

This document describes the Omnia Medical Coupler-A™ Anterior Lumbar Plate System and Omnia Medical Coupler-L™ Lateral Lumbar Plate System, which are spinal intervertebral body fixation orthoses. The document primarily focuses on demonstrating the substantial equivalence of these devices to a predicate device (Stryker LITe® Plate System K221728) through mechanical testing.

Here's the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Feature/Test	Acceptance Criteria (Predicate Performance)	Reported Device Performance (Omnia Medical Coupler-A™ and Coupler-L™)
Mechanical Testing (Static and Dynamic Compression Bending, Static Torsion) as per ASTM F1717	Not explicitly stated with specific numerical values in this document. The document implies the acceptance criterion is the performance of the predicate device (Stryker LITe® Plate System K221728) or general industry standards for such devices.	"Results support that the subject device performs as well as or better than the chosen acceptance criteria." (Specific numerical results are not provided in this summary.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text. The mechanical testing refers to "subject device" and "predicate device," implying samples of both were tested, but no specific number of units or tests is given.
Data Provenance: Not explicitly stated. Mechanical testing is generally conducted in a laboratory setting. There is no indication of country of origin for this data or if it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is mechanical testing of medical devices, not a clinical study involving ground truth established by expert consensus. The "ground truth" here is the physical performance of the devices under specific forces, measured by laboratory equipment against industry standards (ASTM F1717).

4. Adjudication Method for the Test Set

This information is not applicable as the study is mechanical testing and does not involve human interpretation or adjudication.

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

No, a MRMC comparative effectiveness study was not done. This document pertains to the mechanical safety and performance of spinal implants, not an AI-assisted diagnostic tool.

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

No, this is not an algorithm. This document describes the mechanical testing of a physical medical device (spinal plates and screws).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established by engineering standards and physical measurements. Specifically, the performance of the devices is evaluated against ASTM F1717, an industry standard for "Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model." The acceptance criteria are implicitly derived from the performance of the legally marketed predicate device and the requirements of this standard.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning study.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no "training set" or corresponding ground truth establishment process for a mechanical testing study of this nature.

Summary

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April 12, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K230424

Trade/Device Name: Omnia Medical Coupler-A™ Anterior Lumbar Plate System: Omnia Medical Coupler-LTM Lateral Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 15, 2023 Received: February 17, 2023

Dear Ms. 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) K230424

Device Name

Omnia Medical Coupler-ATM Anterior Lumbar Plate System and Omnia Medical Coupler-L™ Lateral Lumbar Plate System

Indications for Use (Describe)

The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

· Pseudoarthrosis;
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
Tumors;
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· Failed Previous Fusion

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/1 description: The image shows the logo for Omnia Medical. The logo consists of a circular graphic on the left and the words "Omnia Medical" on the right. The graphic is divided into two sections, with the top section being dark blue and the bottom section being gray. The words "Omnia Medical" are stacked on top of each other, with "Omnia" on top and "Medical" on the bottom. The word "Omnia" is in a larger font size than the word "Medical", and both words are gray.

510(k) Summary

Submitted By:	Omnia Medical, LLC6 Canyon Road Suite 300Morgantown, WV 26508
Date:	02/16/2023
Contact Person:	Jennifer Palinchik, President, JALEX Medical
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
Contact Address:	JALEX Medical, LLC27865 Clemens Rd Suite 3Westlake, Ohio 44145
Device Trade Name:	Omnia Medical Coupler-A TM Anterior Lumbar Plate System andOmnia Medical Coupler-L TM Lateral Lumbar Plate System
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:	K221728 Stryker LITe® Plate System
	The primary predicate device has never been subject to a recall.

Device Description:

Indications for Use:

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
· Pseudoarthrosis:
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
· Tumors;
· Trauma (i.e. Fractures or Dislocation)

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Image /page/4/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular graphic on the left, with the text "Omnia" in blue and "Medical" in gray on the right. The graphic appears to be a stylized wave or mountain range.

Deformities osis, Kyphosis or Lordosis)
Failed Previous Fusion

Summary of Technological Characteristics:

The Omnia Medical Coupler-A™ Anterior Lumbar Plate System, Omnia Medical Coupler-L™ Lateral Lumbar Plate System and the predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use
Materials
Dimensions ●
Function ●

Table 8.1: Dimensions and Technological Characteristics Comparison Lumbar Plate Systems
Item	Omnia Medical Coupler-A™ andCoupler-L™ Lumbar Plate Systems	Stryker LITe® PlateSystem(K221728)	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 Coupler-A™ and Coupler-L™Lumbar Plate Systems are indicated foruse via a lateral or anterolateral surgicalapproach above the bifurcation of thevessels or via an anterior approachbelow the bifurcation of the greatvessels in the treatment of lumbar andlumbosacral (L1-S1) spine. The systemis intended to provide additional supportduring fusion in skeletally maturepatients in the treatment of the followingacute and chronic instabilities ordeformities:Degenerative Disc Disease (definedas back pain of discogenic originwith degeneration of the discconfirmed by patient history andradiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures orDislocation) Deformities (i.e. Scoliosis, Kyphosisor Lordosis)	The LITe® PlateUniversal, Sacral, 2 Screwand 4 Screw Plates areindicated for use via alateral or anterolateralsurgical approach abovethe bifurcation of thevessels in the treatment ofthe thoracic andthoracolumbar (T1-L5)spine or via an anteriorapproach below thebifurcation of the greatvessels in the treatment oflumbar and lumbosacral(L1-S1) spine. The systemis intended to provideadditional support duringfusion in skeletally maturepatients in the treatment ofthe following acute andchronic instabilities ordeformities:Degenerative DiscDisease (defined asback pain of discogenicorigin withdegeneration of the disc	Equivalent

	• Failed Previous Fusion	confirmed by patienthistory andradiographic studies);• Pseudoarthrosis;• Spondylolysis;• Spondylolisthesis;• Spinal stenosis;• Tumors;• Trauma (i.e. Fracturesor Dislocation)• Deformities (i.e.Scoliosis, Kyphosis orLordosis)• Failed Previous Fusion
Description	The Coupler-ATM and Coupler-LTMLumbar Plate Systems providestabilization to the lumbar spine duringspinal fusion. These systems includeplates, screws, and an instrument setused in the surgical insertion of theimplants. The implants are composed ofTi6Al4V ELI Titanium per ASTMF136. The screws are inserted into thevertebral body through correspondingholes in the plate to achieve fixation. Ascrew locking system is incorporated inthe plate allowing the surgeon to lockthe screws into place with cam screwsafter insertion. The plates are availablein multiple lengths and levels to allowfor utilization in fusion operationsacross L1 to S1 of the lumbar spine. Thesystem instrumentation is manufacturedfrom surgical grade stainless steel andother surgical grade materials. Theinstrumentation is used in the placementand fixing of the device.	The previously cleareddevices consist of a varietyof plate systems designedto provide support acrossimplanted levels in thecervical, thoracolumbar,and lumbosacral spine untilfusion is achieved.	Equivalent
Plate Sizes-Anterior	Anterior Lumbar Plate, L1-L5, 30mm-40mm Length, 21mm WidthAnterior Lumbar Plate, L5-S1, 30mm-40mm Length, 21mm Width	21-37mm 1 LevelUniversal Plate, 26mmWidth21-37mm 1 Level SacralPlate, 21/26mm Widths	Equivalent
PlateThickness-Anterior	3.75mm	3.5mm Universal Plates4.0mm Sacral Plates	Equivalent
Plate Sizes-Lateral	Lateral Lumbar Plate, L1 – L5, 30mm-40mm Length, 18mm Width	2-Screw Lateral:Length - 16mm-28mmWidth – 17 mm4-Screw Lateral:Length - 18mm-28mm	Equivalent
		Width – 21mm
Plate Thickness-Lateral	3.75mm	2-Screw Lateral – 4.5 mm4-Screw Lateral – 4.5 mm	Equivalent
Screw sizes	5.5mm and 6.0mm diameters, varying lengths	5.0mm and 5.5mm diameters, varying lengths	Equivalent
Material	Ti6A14V per ASTM F136	Ti6A14V	Equivalent

Table 8 1: Dimensions and Technological Characteristics Comparison Lumbar Plate Systems

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Image /page/5/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in navy blue and gray, followed by the words "Omnia Medical" in a serif font. The word "Omnia" is in navy blue, and the word "Medical" is in gray.

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Image /page/6/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray abstract wave-like design on the left, followed by the words "Omnia" in blue and "Medical" in gray on the right. The text is in a simple, sans-serif font.

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 performs as well as or better than the chosen acceptance criteria.

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.