EIT Cellular Titanium® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

Device Description

The purpose of this Traditional 510(k) is to seek marketing clearance for the EIT Cellular Titanium® Lumbar Cage LLIF to be added to the EIT Spine line of lumbar interbody cages. The EIT Cellular Titanium® Lumbar Cage LLIF is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).

The EIT Cellular Titanium® Lumbar Cage LLIF is made from Ti-6AI-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the EIT Cellular Titanium® Lumbar Cage LLIF. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study design and ground truth cannot be extracted directly from this document.

However, I can extract the acceptance criteria related to performance testing that was conducted and the reported device performance in relation to these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Type)	Standard Applied	Reported Device Performance
Static Compression	ASTM F2077	Performance testing per ASTM F2077 and ASTM F2267 was conducted. The document states "The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance." This implies the device met the performance requirements of these standards. The acceptance criteria themselves (e.g., minimum compression strength) are not specified in this document.
Static Compression-Shear	ASTM F2077	Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided.
Dynamic Compression	ASTM F2077	Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided.
Dynamic Compression-Shear	ASTM F2077	Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided.
Expulsion	ASTM F2267	Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided.
Subsidence	ASTM F2267	Similar to static compression, performance testing per ASTM F2077 and ASTM F2267 was conducted, and the device was deemed substantially equivalent to predicates in performance. Specific acceptance criteria are not provided.
Biocompatibility Rationale	ISO 10993	Biocompatibility rationale comparing the materials used (Ti-6AI-4V ELI) to manufacture the device and instruments with confirmed biocompatibility profiles per ISO 10993 was demonstrated. This suggests that the materials chosen are biocompatible and therefore meet relevant acceptance criteria for safety. Specific test results or numeric acceptance values are not provided.
MRI Safety Testing	ASTM F2052-15, ASTM F2213-06, ASTM F2182-11a	Performance testing per ASTM F2052-15, ASTM F2213-06, and ASTM F2182-11a was performed. This implies the device meets the safety requirements for MRI compatibility as defined by these standards. Specific results are not provided but substantial equivalence implies success.
Pyrogenicity Testing	Not Specified	Pyrogenicity testing has been completed on the "worst case" EIT lumbar cages. The document states "Equivalence has been established to these EIT lumbar cages and the EIT Cellular Titanium® Lumbar Cage LLIF subject device cages do not introduce a new "worst case" cage. As a result, the pyrogenicity testing completed for the EIT lumbar cage family is applicable to the EIT Cellular Titanium® Lumbar Cage LLIF devices." This implies the device meets pyrogenicity safety standards. Specific acceptance criteria are not provided.

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

This document describes a 510(k) submission based on mechanical testing and a literature review for an allograft bone material claim. It does not refer to a clinical study with a "test set" of patient data for the device itself.

Sample Size for Test Set: Not applicable in the context of the provided document as no human clinical study "test set" is described for the device. The "test set" would refer to engineered devices for mechanical, biocompatibility, and MRI safety testing.
Data Provenance: Not applicable for a clinical test set. The provenance of the testing for the device's physical properties would be from the manufacturer's labs and contracted testing facilities.

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

Not applicable. The ground truth for the device's mechanical, biocompatibility, and MRI safety performance is established by the specified ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There's no human-interpreted "test set" that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. The document does not describe an MRMC comparative effectiveness study for the EIT Cellular Titanium® Lumbar Cage LLIF.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is based on its ability to meet the specifications of the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical performance, biocompatibility, and MRI safety. The "ground truth" for the claim regarding allogenic bone graft materials comes from a "comprehensive clinical literature review."

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant and there is no mention of a "training set" in the context of machine learning. If referring to manufacturing controls, the sample size would be related to quality control processes.

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

Not applicable. There is no training set described in the provided document.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 12, 2018

EIT Emerging Implant Technologies GmbH % Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20005

Re: K181644

Trade/Device Name: EIT Cellular Titanium® Lumbar Cage LLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 4, 2018 Received: October 5, 2018

Dear Justin Eggleton:

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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Brent Showalter -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

510(k) Number (if known) K181644

Device Name

EIT Cellular Titanium® Lumbar Cage LLIF

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Permitted Use (Part 21 CFR 201 Subpart D)	☑
Over-The-Counter Use (21 CFR 201 Subpart C)	☐

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	EIT Cellular Titanium® Lumbar Cage LLIF
Manufacturer:	EIT Emerging Implant Technologies GmbHEisenbahnstrasse 8478573 Wurmlingen, GermanyPhone: +49 7461 1716900
Contact:	Mrs. Barbara WirthEIT Emerging Implant Technologies GmbHEisenbahnstrasse 8478573 Wurmlingen, Germany
Prepared by:	Mr. Justin EggletonSenior Director, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com
Date Prepared:	October 12, 2018
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	MAX

Indications for Use:

EIT Cellular Titanium® Lumbar Cage LLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Device Description:

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and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with autogenous bone graft and/or allogenic bone graft materials. The EIT Cellular Titanium® Lumbar Cage LLIF is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation. either applied anteriorly or posteriorly (e.g., using posterior pedicle screws).

Primary Predicate Device:

The EIT Cellular Titanium® Lumbar Cage LLIF is substantially equivalent to the SPINEART JULIET® LL Lateral Lumbar Cage in device indications, surgical approach, design, and performance.

Table 1: Primary Predicate Devices
Manufacturer	Device Name	K-Number
SPINEART	JULIET® LL Lateral Lumbar Cage	K161888

Additional Predicate Devices:

The EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, and EIT Cellular Titanium® ALIF Cages (EIT Emerging Implant Technologies, GmbH) (K172888) are substantially equivalent to the subject device with respect to indications, design, additive manufacturing process, and performance.

Performance Testing Summary:

The testing of the EIT Cellular Titanium® Lumbar Cage LLIF and cage-dedicated instruments includes:

Mechanical testing per ASTM F2077 and ASTM F2267: Static compression, static ● compression-shear, dynamic compression, dynamic compression-shear, expulsion, and subsidence
Biocompatibility rationale comparing the materials used to manufacture the device ● and instruments with confirmed biocompatibility profiles per ISO 10993.
MRI Safety Testing per ASTM F2052-15, ASTM F2213-06, and ASTM F2182-● 11a

The subject device, the EIT Cellular Titanium® Lumbar Cage LLIF, can be used with autogenous bone graft and/or allogenic bone graft materials to facilitate fusion. Both the primary and secondary predicate devices are indicated for use only with autogenous bone graft. As a result of the inclusion of allogenic bone graft materials in this submission, a comprehensive clinical literature review was performed to show the clinical performance of allograft bone materials for lumbar interbody fusion.

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Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance. Pyrogenicity testing has been completed on the "worst case" EIT lumbar cages. Equivalence has been established to these EIT lumbar cages and the EIT Cellular Titanium® Lumbar Cage LLIF subject device cages do not introduce a new "worst case" cage. As a result, the pyrogenicity testing completed for the EIT lumbar cage family is applicable to the EIT Cellular Titanium® Lumbar Cage LLIF devices.

Conclusion:

The EIT Cellular Titanium® Lumbar Cage LLIF is substantially equivalent to the cited predicate devices with respect to its indications for use, design, function, materials, and performance.

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.