The KMTI S141 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Device Description

The Kyocera Medical Technologies, Inc. (KMTI) KMTI S141 Lumbar Interbody Fusion System (also called S141 LIF System) consists of cages which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion. The S141 LIF System includes the Tesera-P, Tesera-T, PEEK Straight TLIF, and PEEK TLIF families. The implants are offered in additively manufactured Titanium Alloy (Titanium-6Aluminum-4Vanadium) per ASTM F2924 and PEEK (Polyetheretherketone) per ASTM F2026.This submission updates the subject titanium alloy material specifications and standards, modifies the additive printing process, and expands the for the previously cleared S141 Lumbar Interbody Fusion System.

The KMTI S141 Lumbar Interbody Fusion System is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. The implants may be inserted via an open or minimally invasive approach. The Tesera P and PEEK PLIF use a posterior approach. The PEEK Straight TLIF, Tesera ST, and Tesera T use an oblique approach. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The superior and inferior surfaces of the Titanium Alloy implant consist of Tesera porous titanium structure to facilitate osseous integration. The superior and inferior surfaces of the S141 PEEK devices have "teeth" to help prevent the device from migration after surgically positioned. Additionally, the S141 PEEK devices contain tantalum markers (per ASTM F560) to assist the surgeon with proper placement of the device. The implants are provided terminally sterilized via gamma irradiation prior to end-user receipt.

AI/ML Overview

This document describes a 510(k) premarket notification for the KMTI S141 Lumbar Interbody Fusion System, which is a medical device for spinal fusion.

Here's the breakdown of the acceptance criteria and the study performed, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Adequate and substantially equivalent mechanical strength for intended use.	Mechanical testing demonstrated adequate and substantially equivalent mechanical strength for its intended use.
Similar intended uses and indications.	Identical to primary predicate device.
Similar technological characteristics.	Nearly identical to predicate devices; minor differences do not raise new safety/effectiveness issues.
Similar principles of operation.	Similar to predicate devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing" was conducted, but does not provide details on the number of devices or iterations tested.
Data Provenance: The testing was conducted by Kyocera Medical Technologies, Inc. within the context of a 510(k) submission to the FDA. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the study presented is a mechanical performance study, not a clinical study involving ground truth established by experts.

4. Adjudication method for the test set

This question is not applicable as the study presented is a mechanical performance study, not a clinical study requiring adjudication of expert opinions.

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 question is not applicable. The device is an intervertebral body fusion system, a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the device is a physical implant, not an algorithm.

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

The "ground truth" for the mechanical testing would be defined by engineering specifications and established performance standards for spinal implants, as derived from the predicate devices and relevant ASTM standards (e.g., ASTM F136, F2924, F2026, F560 mentioned for materials). The device's mechanical strength was compared to these standards and to the performance of predicate devices to establish substantial equivalence.

8. The sample size for the training set

This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

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

This question is not applicable This is a mechanical device, not an AI/machine learning system that requires a training set.

Summary

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August 30, 2021

Kyocera Medical Technologies, Inc. % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212070

Trade/Device Name: KMTI S141 Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2021 Received: August 23, 2021

Dear Nathan Wright:

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

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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,

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

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4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)

K212070

Device Name

Kyocera Medical Technologies, Inc. (KMTI) S141 Lumbar Interbody Fusion System Indications for Use (Describe)

Deqenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

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Submitter's Name:	Kyocera Medical Technologies, Inc.
Submitter's Address:	1200 California St, Suite 210Redlands, CA 92374
Submitter's Telephone:	909-557-2360
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	July 1, 2021
Trade or Proprietary Name:	KMTI S141 Lumbar Interbody Fusion System
Common or Usual Name:	Intervertebral body fusion device
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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The indications for use for the KMTI LIF System are identical to those of the primary predicate.

TECHNICAL CHARACTERISTICS

The purpose of this system is to expand the product line of the KMTI S141 Lumbar Interbody Fusion System with additional sizes offered and to modify the material and manufacturing method for the KMTI S141 devices which were previously cleared. The KMTI S141 Lumbar Interbody Fusion System is made from Ti-6A1-4V ELI per ASTM F136 or Ti-6Al-4V per F2924 or from PEEK per ASTM F2026 with tantalum per ASTM F560. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Indications for Use ●
Structural support mechanism ●
Sizes ●

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K170888, K143126	Renovis S141 Lumbar InterbodyFusion System	Renovis SurgicalTechnologies	Primary
K181655	Renovis S180 Lateral LumbarInterbody Fusion System	Renovis SurgicalTechnologies	Additional
K171657	ShurFit 2C Lumbar InterbodyFusion System	Precision Spine, Inc.	Additional
K113561	TM Ardis® Interbody System	Zimmer TrabecularMetal Technology, Inc.	Additional
K201605	EIT Cellular Titanium® TLIF Cage	EIT Emerging ImplantTechnologies GmbH	Additional

Table 5-1 Predicate Devices

PERFORMANCE TESTING SUMMARY

In support of this Special 510(k) Device Modification Premarket Notification, Kyocera Medical Technologies, Inc. has conducted mechanical testing to demonstrate that the modifications to the

Kyocera Medical Technologies, Inc. S141 Lumbar Interbody Fusion System

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S141 Lumbar Interbody Fusion System provide adequate and substantially equivalent mechanical strength for their intended use.

CONCLUSION

The subject modified KMTI S141 Lumbar Interbody Fusion System is very similar to previously cleared Renovis S141 Lumbar Interbody Fusion System. The subject KMTI S141 Lumbar Interbody Fusion System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the KMTI S141 Lumbar Fusion System is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A