When used with or without the CONDUIT™ Lateral Switch Plate, the EIT Cellular Titanium® LLIF Cage is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features 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 allogeneve 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 with an intervertebral cage.

Device Description

The CONDUIT™ Lateral Switch Plate ("Plate") is an optional device that connects to the EIT Cellular Titanium® LLIF Cage ("Cage") and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws ("Screws"). The subject device is not considered to be supplemental fixation. Both the Plate and Screws are manufactured from ASTM F136 titanium alloy (Ti-6A1-4V ELI). The Plate is supplied sterile in one- and two-hole configurations in a variety of sizes to attach to one or both adjacent vertebral bodies.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the CONDUIT™ Lateral Switch Plate. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Important Note: The provided document is a 510(k) summary for a mechanical orthopedic implant (CONDUIT™ Lateral Switch Plate) for spinal fusion, not an AI/software as a medical device (SaMD) or a device that typically involves human readers interpreting images, ground truth establishment through expert consensus (radiologists), or MRMC studies. Therefore, many of the requested points related to AI/imaging device validation (e.g., sample size for test/training set in an AI context, expert qualifications, adjudication methods, MRMC studies, effect size of human readers with/without AI, standalone AI performance) are not applicable to this type of device and its non-clinical testing methodology.

The acceptance criteria described here are for demonstrating substantial equivalence based on mechanical, material, and biological safety standards, not diagnostic accuracy or clinical effectiveness in the way an AI medical device would be evaluated.

Acceptance Criteria and Device Performance Study (Non-Clinical)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, the "acceptance criteria" are based on meeting established industry standards for mechanical performance, biocompatibility, and MRI safety, demonstrating similar performance to predicate devices. The document does not provide specific numerical acceptance thresholds within the text itself, but rather states that tests were performed in accordance with the standards and that results demonstrate compliance or substantial equivalence.

Criteria Category	Specific Test	Acceptance Criteria (Implied by Standards)	Reported Device Performance
Mechanical Performance	Dynamic Axial Compression (ASTM F2077-18)	Device withstands specified dynamic axial loads without failure, demonstrating sufficient strength and durability.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
	Dynamic Compression Shear (ASTM F2077-18)	Device withstands specified dynamic compression shear loads without failure.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
	Static Axial Compression analysis (ASTM F2077-18)	Device withstands specified static axial loads without permanent deformation or failure.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
	Static Compression Shear analysis (ASTM F2077-18)	Device withstands specified static compression shear loads without permanent deformation or failure.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
	Subsidence analysis (ASTM F2267-04)	Device demonstrates acceptable resistance to subsidence into vertebral bodies under load.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
	Expulsion analysis	Device demonstrates acceptable resistance to expulsion from the intervertebral space.	"performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices"
Biocompatibility	Biological Evaluation (ISO 10993-1:2018)	Device materials are biocompatible and do not pose unacceptable biological risks (e.g., cytotoxicity, sensitization, irritation).	"The results demonstrate the subject devices comply with the applicable requirements of ISO 10993-1:2018"
MRI Safety	MRI Safety Testing (ASTM F2052-15, F2182-17, F2119-07, F2182-19e2)	Device exhibits acceptable MRI compatibility (e.g., minimal artifact, safe temperature rise, acceptable magnetic field interactions).	"evaluated and tested in accordance with... ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2"

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

Sample Size: The document does not specify the exact number of test samples (e.g., number of plates tested) for each mechanical test. For devices cleared via 510(k), testing is typically performed on a sufficient number of samples (e.g., 3-6 or more) per configuration to demonstrate compliance with the chosen standard. These are non-clinical (
in vitro) tests, not tests on patient data.
Data Provenance: The data provenance is in-vitro laboratory testing. There is no patient-specific data or country of origin mentioned for the "test set" as this is not a study using clinical data. The tests are performed on the device prototypes themselves.

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

Not Applicable. For mechanical device testing for 510(k) clearance, "ground truth" is not established by medical experts like radiologists. Ground truth is defined by the objective measurements and pass/fail criteria of the ASTM/ISO standards for mechanical, material, and biological properties. The "experts" involved would be engineers and scientists performing and interpreting the laboratory tests according to the standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used for "reading" studies involving human interpretation of medical images or data. For mechanical device testing, the results are quantitative measurements against predefined (standardized) physical acceptance criteria. There is no subjective interpretation requiring adjudication.

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

No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive medical device, often AI-based, on reader performance using medical images. This device is a mechanical orthopedic implant, and such a study is not relevant to its clearance.

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

Not Applicable. This is not an algorithm or AI-based device. "Standalone performance" here would refer to the mechanical device's performance in isolation, which is precisely what the listed mechanical and material tests (e.g., axial compression, shear, subsidence) evaluate.

7. The Type of Ground Truth Used

Engineering Standards and Specifications: The "ground truth" for this device's performance is defined by adherence to specific, published, and internationally recognized engineering standards (ASTM and ISO). These standards specify test methods, fixtures, loading conditions, and acceptance criteria (implied or explicit) for the mechanical and biological properties of implantable devices. The "truth" is whether the device meets these pre-defined, objectively measurable criteria.

8. The Sample Size for the Training Set

Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a mechanical implant; there is no AI algorithm being trained. The "design and development" process would involve iterative prototyping and testing, but not a "training set" in the machine learning sense.

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

Not Applicable. As there is no AI algorithm and thus no "training set," this question is not relevant. The design and validation of this mechanical device rely on engineering principles, materials science, and testing against established performance standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2022

Medos International, SARL % LiJuan He Associate Director, Regulatory Affairs DePuy Spine 325 Paramount Dr. Raynham, Massachusetts 02767

Re: K221325

Trade/Device Name: CONDUIT™ Lateral Switch Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: July 27, 2022 Received: July 28, 2022

Dear LiJuan He:

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

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

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 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,

Brent Showalter, Ph.D. 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

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

Indications for Use

510(k) Number (if known) K221325

Device Name CONDUIT™ Lateral Switch Plate

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the DePuy Synthes logo. The logo consists of a red figure-eight-like symbol on the left, followed by the words "DePuy Synthes" in gray. Below the company name, it says "THE ORTHOPAEDICS COMPANY OF" in smaller gray font, followed by "Johnson & Johnson" in red script.

510(K) SUMMARY

A.	Submitter Information
	Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
	Contact Person:Telephone:Email:	LiJuan He978-406-7629lhe10@its.jnj.com
B.	Date Prepared	August 19, 2022
C.	Device Name
	Trade/Proprietary Name:	CONDUIT™ Lateral Switch Plate
	Device Classificationand Regulation:	Class II per 21 CFR §888.3080
	Product Codes:	MAX, OVD
D.	Predicate Device Names
	Primary Predicate:	Nuvasive Modulus XLIF (K192760)
	Additional Predicate:	EIT Cellular Titanium® Lumbar Cage LLIF(K181644); EIT Cellular Titanium® CervicalCage (K201605)

E. Device Description Summary

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

Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes, a company that specializes in orthopedics. The logo features a red abstract symbol on the left, followed by the company name in gray, with the words "THE ORTHOPAEDICS COMPANY OF" in smaller gray font underneath. Below that is the Johnson & Johnson logo in red script.

F. Indented Use/Indications for Use

The EIT Cellular Titanium® LLIF Cage with a microscopic roughened surface and micro and nano-scale features 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 nonoperative treatment prior to treatment with an intervertebral cage.

G. Indications for Use Comparison

The subject device (Plate) with the EIT Cellular Titanium® Lumbar LLIF Cage and screws comprise an implant system which has indications for use similar to those of the predicate devices.

F. Non-Clinical Test Summary and Conclusions

1. Mechanical Testing
  The following tests and analyses were performed on the subject device system to demonstrate that the CONDUIT™ Lateral Switch Plate is substantially equivalent to other predicate devices:
· Dynamic Axial Compression (ASTM F2077-18)
· Dynamic Compression Shear (ASTM F2077-18)
· Static Axial Compression analysis (ASTM F2077-18)
· Static Compression Shear analysis (ASTM F2077-18)
· Subsidence analysis (ASTM F2267-04)
Expulsion analysis
1. The subject devices were evaluated and tested in accordance with ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process. The results demonstrate the subject devices comply with the applicable requirements of ISO 10993-1:2018
1. MRI Safety Testing per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2

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

Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, The Orthopaedics Company of Johnson & Johnson. The logo features a red symbol resembling a stylized spine or interconnected loops on the left. To the right of the symbol is the company name "DePuy Synthes" in a bold, gray sans-serif font. Below the company name, in a smaller font, is the text "THE ORTHOPAEDICS COMPANY OF" followed by "Johnson & Johnson" in a red, cursive script.

The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing per testing standards.

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.