The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Device Description

The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Eminent Spine 3D Lumbar Interbody Fusion Systems." This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than outlining acceptance criteria and a detailed study proving the device meets those criteria in the context of a typical AI/medical device performance study.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

The document mentions "acceptance criteria" not for clinical or diagnostic performance, but for mechanical testing.

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Static axial compression per ASTM F2077	Device performs as well as or better than acceptance criteria.
Static axial compression-shear per ASTM F2077	Device performs as well as or better than acceptance criteria.
Dynamic axial compression per ASTM F2077	Device performs as well as or better than acceptance criteria.
Dynamic axial compression-shear per ASTM F2077	Device performs as well as or better than acceptance criteria.
Subsidence per ASTM F2267	Device performs as well as or better than acceptance criteria.
Expulsion	Device performs as well as or better than acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to mechanical testing, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes mechanical testing of an implantable device, not an AI or diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes mechanical testing.

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

This information is not applicable as the document describes mechanical testing of an implantable device, not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes mechanical testing of an implantable device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be established by the physical testing standards (ASTM F2077, ASTM F2267) and their specified measurement methods and acceptable limits. It's not a biological "ground truth" as typically discussed in diagnostic studies.

8. The sample size for the training set

This information is not applicable as the document describes mechanical testing of a physical device, not an AI algorithm.

9. How the ground truth for the training set was established

This information is not applicable as the document describes mechanical testing of a physical device.

Summary of the Study:

The "study" described in this 510(k) summary is a series of mechanical tests designed to ensure the Eminent Spine 3D Lumbar Interbody Fusion Systems possess adequate strength and stability for their intended use. These tests were conducted according to ASTM standards (F2077 for static and dynamic testing, F2267 for subsidence), and an additional test for expulsion. The conclusion is that the device "performs as well as or better than the chosen acceptance criteria," which are implicitly defined by compliance with these ASTM standards and any internal specifications. The purpose of these tests is to demonstrate that the new device is mechanically equivalent to the predicate devices and safe for its intended surgical application, not to evaluate diagnostic performance or AI effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 16, 2023

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

Re: K230219

Trade/Device Name: Eminent Spine 3D Lumbar Interbody Fusion Systems Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 14, 2023 Received: March 14, 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.

{1}------------------------------------------------

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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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. Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230219

Device Name

Eminent Spine 3D Lumbar Interbody Fusion Systems

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
</span> Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a spine-like design in the center, surrounded by a golden, curved shape. The text "EMINENT" is displayed above the word "SPINE" in a smaller font size.

510(k) Summary

Submitted By:	Eminent Spine, LLC2004 Ventura Dr. Suite #100Plano, TX 75093
Date:	05/15/2023
Contact Person:	Jennifer Palinchik, President, JALEX Medical
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
Device Trade Name:	Eminent Spine 3D Lumbar Interbody Fusion Systems
Common Name:	Intervertebral Body Fusion Device
Device Classification Name:	Intervertebral Body Fusion Device with Bone Graft, Lumbar
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	MAX
Primary Predicate Device:	Eminent Spine Interbody Fusion System (K090064)
Additional Predicate Devices:	Eminent Spine 3D Cervical Interbody Fusion System (K212701)CancelleX Porous Titanium Lumbar Interbody Device (K190364)

Device Description:

Indications for Use:

The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Summary of Technological Characteristics:

The Eminent Spine 3D Lumbar Interbody Fusion Systems and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a golden spine with a sword running through it, surrounded by a golden arch. The text "EMINENT" is written above the text "SPINE" in a smaller font.

Design features .
Intended use
Materials ●
Dimensions .
Function ●

Table 1: Dimensions and Technological Characteristics Comparison

Item	Eminent Spine 3DLumbar InterbodyFusion Systems	Eminent SpineInterbody FusionSystem (K090064)	Eminent Spine 3DCervical InterbodyFusion System(K212701)	Comparison
ClassificationName	Intervertebral BodyFusion Device	Intervertebral BodyFusion Device	Intervertebral BodyFusion Device	Equivalent
Regulation	888.3080	888.3080	888.3080	Equivalent
Product Code	MAX	MAX, MQP, ODP	ODP	Intervertebralbody fusiondevice codeequivalent toprimarypredicate
Indications forUse	The Eminent Spine 3DLumbar InterbodyFusion Systems (PLIF,TLIF, and ALIF) areindicated forintervertebral bodyfusion of the lumbarspine, from L2 to S1, inskeletally maturepatients who have hadsix months of non-operative treatment.The device is intendedfor use at either onelevel or two contiguouslevels for the treatmentof degenerative discdisease (DDD) with upto Grade Ispondylolisthesis. DDDis defined as back painof discogenic originwith degeneration ofthe disc confirmed byhistory andradiographic studies.The device system isdesigned for use withsupplemental fixationand autograft tofacilitate fusion.	The Eminent SpineInterbody FusionSystem (Sidewinder,Python andCottonmouth) isindicated forintervertebral bodyfusion of the lumbarspine, from L2 to S1, inskeletally maturepatients who have hadsix months of non-operative treatment.The device is intendedfor use at either onelevel or two contiguouslevels for the treatmentof degenerative discdisease (DDD) with upto Grade Ispondylolisthesis. DDDis defined as back painof discogenic originwith degeneration ofthe disc confirmed byhistory andradiographic studies.The device system isdesigned for use withsupplemental fixation	The Eminent Spine 3DCervical InterbodyFusion System isindicated forintervertebral bodyfusion in skeletallymature patients withdegenerative discdisease (DDD) of thecervical spine at onedisc level from the C2-C3 disc to the C7-T1disc. DDD is defined asdiscogenic pain withdegeneration of the discconfirmed by historyand radiographicstudies. The devicesystem is designed foruse with supplementalfixation and autograft tofacilitate fusion.Patients should have atleast six (6) weeks ofnon-operative treatmentprior to treatment withan intervertebral cage.	Intervertebralbody fusionindicationsequivalent toprimarypredicate

Hyperlordotic interbodydevices (≥20° lordosis)must be used with atleast anteriorsupplemental fixation.	and autograft tofacilitate fusion.The Eminent SpineSystem of implants isindicated for use toreplace a vertebral bodythat has been resectedor excised (i.e. partialor total vertebrectomy)due to tumor ortrauma/fracture. Theimplant is intended foruse in thethoracolumbar spine(from T1 to L5) and isintended for use withsupplemental internalfixation and autograftor allograft bone. Thesedevices are designed torestore thebiomechanical integrityof the anterior, middleand posterior spinalcolumn even in theabsence of fusion for aprolonged period.
Description	The Eminent Spine 3DLumbar InterbodyFusion Systems areintervertebral bodyfusion systems used inthe spine to replace acollapsed, damaged, orunstable disc. The 3DLumbar InterbodyFusion Systems (PLIF,TLIF, and ALIF) arecomprised of varioussizes and configurationsto accommodateindividual patientanatomy. Theconfigurations aredesigned to provide thesurgeon with differentsurgical approachoptions, and packedwith autogenous bonegraft to facilitate fusion.	The Eminent SpineInterbody FusionSystem is comprised ofvarious sizes andconfiguration toaccommodateindividual patientanatomy. Theconfigurations aredesigned to provide thesurgeon with differentsurgical approachoptions.	The Eminent Spine 3DCervical InterbodyFusion System iscomprised of varioussizes and configurationto accommodateindividual patientanatomy. The device isa hollow rectangularshaped block, which isavailable in a parallel orlordotic configurations.The device is hollow toallow for placement ofbone graft. There areteeth on the superiorand inferior surfaces ofthe device to inhibitmovement of thedevice.	Equivalent toprimarypredicate

	surfaces of each devicegrip the endplates of theadjacent vertebralbodies to aid inexpulsion resistance.The device is intendedto provide mechanicalsupport to theimplanted level untilbiologic fusion isachieved.
Footprints	PLIF: 22-31 mm x 9-12mmTLIF: 28-34 mm x 11mmALIF: 32-42 mm x 21-28 mm	Python (PLIF): 22-31mm x 9-12 mmSidewinder (TLIF): 28-31 mm x 11 mmCottonmouth (ALIF):32-42 mm x 21-28 mm	14x12 mm, 15x13 mm,17x12 mm,17x14 mm, 19x16 mm	Equivalent toprimarypredicate
Heights	PLIF: 6-18 mmTLIF: 6-18 mmALIF: 10-20 mm	Python (PLIF): 6-18mmSidewinder (TLIF): 6-18 mmCottonmouth (ALIF):10-20 mm	5-12 mm	Equivalent toprimarypredicate
Lordotic angle	6°, 12°, 18°, 24°, 30°(depending on model)	6°, 12°, 18°, 24°, 30°(depending on model)	0°, 6°	Equivalent toprimarypredicate
Material	Ti-6Al-4V per ASTMF3001	PEEK Optima LT1 andTi-6Al-4V ELI perASTM F136	Ti-6Al-4V per ASTMF3001	Equivalent toadditionalpredicate

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a twisted blade, positioned vertically. The sword is surrounded by a golden, semi-circular frame, and the words "EMINENT SPINE" are written in a serif font below the sword.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a golden spine with a sword running through it, surrounded by a golden, curved frame. The text "EMINENT" is written in a serif font above the word "SPINE", which is in a smaller font.

Mechanical Testing:

Substantial equivalence is supported by the results of mechanical testing, including static axial compression, static axial compression-shear, dynamic axial compression, dynamic axial compressionshear per ASTM F2077, subsidence per ASTM F2267, and expulsion. 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

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.