The KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) 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 Tesera SA ALIF 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 Tesera SA ALIF System is a standalone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

Device Description

The Kyocera Medical Technologies, Inc. Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System is a change to the FDA cleared Kyocera S128 Anterior Lumbar Interbody Fusion (ALIF) System (Ti6Al4V and PEEK cages, Cover Plate, screws and instruments; K131122. K140106. and K180502). Only the Ti6Al4V cages are relevant to this application which describes a change in manufacturing and material standard. There are no other changes in cage dimensions (L, W, H and lordosis), sterilization, packaging or shelf-life. The new system will be marketed as the Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System ("Tesera SA ALIF System") and will include Ti6Al4V cages only.

The Tesera SA ALIF System includes cages of a variety of lengths, widths, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. Tesera SA ALIF System cages are standalone when implanted with the Cover Plate and screws with the exception of implants ≥20° which require supplemental fixation.

The Ti6Al4V is compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
The Tesera SA ALIF System cages that are the subject of this application are gamma sterilized.

The system also includes the previously FDA cleared Cover Plate and screws; previously FDA cleared and new instruments to allow for implant determination, trialing and disc preparation. New instruments are manufactured from stainless steels compliant with ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

AI/ML Overview

This document describes the KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, which is a medical device. The information provided is primarily for a 510(k) premarket notification, indicating the device is substantially equivalent to previously cleared devices. Therefore, the "acceptance criteria" and "device performance" are primarily benchmarks against predicate devices and adherence to relevant ASTM standards, rather than clinical trial results with specific performance metrics like sensitivity or specificity for AI.

Here's an analysis based on the provided text, focused on aspects relevant to device performance and study methodology, even if not directly an "AI" study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Device Performance
Compliance with ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices (Dynamic Shear Compression)	Successful dynamic shear compression testing conducted.
Compliance with ASTM E8/E8M-16 Standard Test Methods for Tension Testing of Metallic Materials	(Not explicitly stated as a test conducted for this submission, but implies material properties meet this standard)
Compliance with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion (for Ti6Al4V material)	Cages are manufactured to ASTM F2924.
Manufacturing change validation	Manufacturing change has been validated.
Substantial equivalence to predicate devices (K131122, K140106, K180502) in terms of indications for Use, dimensions, sizes, packaging, and sterilization.	The Tesera SA ALIF System has the same Indications for Use as the predicate devices. The cages are additively manufactured; have the same dimensions and sizes, are packaged and gamma sterilized the same as the predicate cages.
Absence of new or different issues of safety or effectiveness associated with the new cages.	The change in manufacturing and material standard do not result in new or different issues of safety or effectiveness associated with the new cages.

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

The provided text does not describe a clinical study with a "test set" in the context of an AI device. The performance evaluation is based on bench testing of the device itself and comparison to predicate devices. Therefore, a sample size for a test set of patient data, data provenance, or retrospective/prospective nature is not applicable here. The "sample" in this context refers to the manufactured devices tested. The document does not specify the exact number of devices or test specimens used for the bench testing.

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

Not applicable. This is not an AI study involving human expert ground truth for interpretation of medical images or data. The "ground truth" for this device's performance is established by engineering standards and direct physical testing of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described for the bench testing. Compliance with standards and successful performance are determined by the test results themselves.

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

Not applicable. This is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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 device. The device itself (an interbody fusion system) is "standalone" in the sense that it doesn't require "additional supplementary fixation" in most cases, but this is a physical characteristic, not an algorithmic performance metric.

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

The "ground truth" for the device's technical performance is based on:

Established engineering standards: ASTM F2077-18, ASTM E8/E8M-16, ASTM F2924.
Physical properties and performance characteristics measured during bench testing (e.g., dynamic shear compression).
Comparison to previously cleared predicate devices based on design, materials, manufacturing processes, and intended use.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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

February 4, 2020

Image /page/0/Picture/1 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 and 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.

Kyocera Medical Technologies, Inc. % Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland, Massachusetts 01721

Re: K193320

Trade/Device Name: KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: December 17, 2019 Received: December 18, 2019

Dear Dr. Orton:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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

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.

for

Brent L. Showalter, Ph.D. Assistant Director (Acting) 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) K193320

Device Name

KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System

Indications for Use (Describe)

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)

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}------------------------------------------------

rg Kyocera

Traditional 510(k) Premarket Notification Summary as required by 21 CFR 807.92(a) K193320

A ) Submitted by:	Kyocera Medical Technologies, Inc.1200 California St. Suite 210Redlands, CA 92374Phone: 909-557-2360Fax: 909-839-6269
Official Contact:	Anthony DeBenedictisDivisional Vice President of Quality Assurance
Consultant:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721
B) Classification Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Common Name:	Intervertebral body fusion device
Proprietary Name:	KMTI Tesera SA Anterior Lumbar Interbody Fusion System
Device Class:	Class II
Regulationsand Product Code:	21 CFR 888.3080OVD
Classification panel:	Orthopedic
C) Predicates:	Primary: K131122 Renovis S128 Anterior Lumbar InterbodyFusion (ALIF) SystemSecondary: K140106 Renovis S128 Anterior Lumbar InterbodyFusion (ALIF) System

Fusion (ALIF) System

Secondary: K180502 Renovis S128 Anterior Lumbar Interbody

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

January 31, 2020 D) Date Prepared:

E) Device Description:

The Ti6Al4V is compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
The Tesera SA ALIF System cages that are the subject of this application are gamma sterilized.

F) Intended Use/Indications For Use:
The KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) 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 Tesera SA ALIF 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 Tesera SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized

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

whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

G) Substantial Equivalence Comparison and Discussion

The Tesera SA ALIF System has the same Indications for Use as the predicate devices. The cages are additively manufactured; have the same dimensions and sizes, are packaged and gamma sterilized the same as the predicate cages. The new cages are manufactured to ASTM F2924, which is appropriate for additive manufacturing. The Tesera SA ALIF System cages are additively manufactured using the same technology and material standard as the FDA cleared K181655 Kyocera S180 Lateral Lumbar Interbody Fusion (LLIF) System cages (reference device). The manufacturing change has been validated.

H) Performance – Bench

The new changes were assessed for risk and successful dynamic shear compression testing conducted.

Compliance with Standards or FDA Guidance I)
The Tesera SA ALIF System complies with the following:
ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices .
. ASTM E8/E8M-16 Standard Test Methods for Tension Testing of Metallic Materials
. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007

Conclusion

The change in manufacturing and material standard do not result in new or different issues of safety or effectiveness associated with the new cages.

The Tesera SA ALIF System is substantially equivalent to the predicate devices.

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.