The KMTI PEEK 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-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK 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 PEEK 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 whenever the device is implanted using the bone screws provided. Should the surgeon choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use inthe lumbar spine must be used. Supplemental fixation, cleared by the FDA for use inthe lumbosacral spine, must be used with implants ≥ 20°.

Device Description

The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System consists of PEEK cages, titanium screws, and a titanium cover plate. The KMTI PEEK SA ALIF System cages are intended to be used with the bone screws, the anterior cover plate assembly (cover plate), and do not require supplementary fixation systems unless less than four bone screws are utilized or cage lordosis is ≥20°. The screws protrude through the interbody portion of the cage implant and stabilize the vertebral body while preventing expulsion of the cage implant. The KMTI PEEK SA ALIF System offers hexalobe drive with both fixed and variable angle screw options. The fixed angle screw option provides a tighter fit with the cage than the variable angle screws while the variable angle screw option provides more clearance between the screw than the fixed screw, which allows for a small amount of screw angulation. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. The cover plate assembly and screw are part of the implant construct.

The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs.

The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only.

AI/ML Overview

The provided text is a 510(k) summary for the Kyocera Medical Technologies, Inc. PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through clinical studies or extensive standalone device performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text, because the submission explicitly states:

"Performance testing was not required in this submission for the modifications proposed."

The primary purpose of this submission is to introduce non-sterile packaging for previously cleared cage sizes. The device's substantial equivalence is based on its technological characteristics being identical to the predicate device, not on new performance data demonstrating its effectiveness against predefined metrics.

However, I can extract what is implied regarding the "proof" of the device meeting its intended purpose for substantial equivalence based on the provided document:

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

Since this is a 510(k) submission focused on substantial equivalence and minor modifications (non-sterile packaging), the "acceptance criteria" are implied by the features demonstrated to be identical to the predicate device. "Device performance" in this context refers to the demonstration of these identical characteristics.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in submission)
Identical Indications for Use	Identical to predicate device
Identical Principle of Operation	Identical to predicate device
Identical Structural Support Mechanism	Identical to predicate device
Identical Materials of Manufacture	Identical to predicate device
Identical Sizes	Identical to predicate device
Sterilization validated for new packaging	Validated according to ISO 17665-1

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

Sample Size for Test Set: Not applicable in the context of performance testing for this submission as "Performance testing was not required." The comparison is based on the inherent design and materials of the device being identical to the predicate.
Data Provenance: Not applicable for performance testing. The "data" pertains to the specifications and design files of the device itself and its predicate.

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)

Not applicable. No "ground truth" establishment by experts for a test set was required for this substantial equivalence submission.

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

Not applicable. No clinical or performance test set requiring adjudication was performed.

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 device is a physical intervertebral body fusion system, not an AI/software device.

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

Not applicable. This device is a physical intervertebral body fusion system, not an algorithm. The "standalone" aspect mentioned in the Indications for Use ("The KMTI PEEK 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") refers to its mechanical functionality as an implant, not standalone algorithmic performance.

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

Not applicable. No performance data requiring "ground truth" was generated for this submission. The "truth" for substantial equivalence is based on the objective technological characteristics being identical to the predicate.

8. The sample size for the training set

Not applicable. No machine learning or AI model was developed or trained for this submission.

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

Not applicable. No machine learning or AI model was developed or trained for this submission.

Summary of "Proof" in this 510(k) Submission:

The "proof" in this document is not derived from clinical trials, observational studies, or performance testing against specific acceptance criteria. Instead, the proof that the device "meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence with minor changes) is based on the following:

Demonstration of Identical Technological Characteristics: The submission explicitly states, "The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device." This is the core "proof."
Validation for Sterilization Changes: For the minor modification of non-sterile packaging, the submission states, "Changes in sterilization were validated according to ISO 17665-1." This ensures that the new packaging method meets international standards for sterilization processes, thereby addressing any potential safety concerns related to the change.

In essence, the device is considered to "meet acceptance criteria" because it is fundamentally the same device as one already cleared by the FDA (the predicate), with a validated change to its packaging.

Summary

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April 21, 2023

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

Re: K230808

Trade/Device Name: PEEK 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: March 23, 2023 Received: March 23, 2023

Dear Mr. 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 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 -S

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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Indications for Use

Submission Number (if known)

K230808

Device Name

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

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}

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10. 510(K) SUMMARY

Submitter's Name:	Kyocera Medical Technologies, Inc.
Submitter's Address:	1200 California StreetSuite 210Redlands, CA 92374
Submitter's Telephone:	909-557-2360
Contact Person:	Nathan Wright MSEmpirical Technologies719-351-0248nwright@empiricaltech.comImage: Empirical Technologies Logo
Date Summary was Prepared:	March 23 2023
Trade or Proprietary Name:	PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Device Classification Name:	Intervertebral Fusion Device with Integrated Fixation, Lumbar
Classification & Regulation #:	Class II per 21 CFR §888.3080
Product Code:	OVD
Classification Panel:	Orthopedic Devices - Spinal Devices (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs.

The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only.

INDICATIONS FOR USE

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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°.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device. Specifically, the following characteristics are identical between the subject and predicates.

Indications for Use
. Principle of Operation
Structural Support Mechanism
Materials of Manufacture ●
Sterilization
Sizes ●

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K180502	S128 Anterior Lumbar Interbody Fusion (ALIF) System	Renovis Surgical Technologies Inc	Primary
K131122	S128 Anterior Lumbar Interbody Fusion (ALIF) System	Renovis Surgical Technologies Inc	Additional

PERFORMANCE DATA

Performance testing was not required in this submission for the modifications proposed. Changes in sterilization were validated according to ISO 17665-1.

CONCLUSION

The overall technology characteristics are identical between the subject and predicates which leads to the conclusion that the PEEK SA ALIF System is substantially equivalent to the predicate device.

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.