The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

Device Description

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers.

The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called the Skyway Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the kind of performance data (e.g., AI model performance metrics, clinical study outcomes) typically associated with acceptance criteria for novel software-based devices, especially those using artificial intelligence.

The information provided explicitly states: "No performance testing was required for this 510(k)." This is because the submission is a "Special 510(k)" to introduce minor changes (non-sterile plate options and minor geometric modifications) to an already cleared device. Therefore, the questions related to AI model performance, sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment, etc., are not applicable to this specific 510(k) submission.

Based on the provided text, here's an attempt to answer the questions within the scope of what is stated:

Acceptance Criteria and Device Performance for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System (K250486)

As this is a Special 510(k) for minor modifications to an already cleared device, the "acceptance criteria" primarily revolve around demonstrating that the changes do not adversely affect the foundational safety and efficacy already established for the predicate device. The "study" described is a regulatory review process to confirm this, rather than a de novo clinical or performance study of the device's functional performance in a use-case scenario.

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

Acceptance Criteria (Implied for a Special 510(k))	Reported Device Performance (as per document)
A. Equivalence to Predicate Device: Changes do not raise new questions of safety or efficacy compared to the predicate.	"There are no differences between the subject and predicate device which raise questions for safety and efficacy."
B. Sterilization Equivalence: Non-sterile options can be adequately sterilized using established methods.	"The modification to offer non-sterile plates was evaluated to determine that the sterilization set for the subject non-sterile devices is adopted into the sterilization adoption per ISO 17665-1 of a worst-case sterilization set."
C. Geometric Modification Impact: Minor dimensional changes to screw holes and screw heads do not compromise performance.	"to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes." (Implicitly accepted as not raising new safety/efficacy questions).
D. Adherence to Regulations: Compliance with all applicable FDA regulations (e.g., 21 CFR 888.3060, 888.3080).	Device cleared as Class II under 21 CFR 888.3060; also refers to QS regulation, UDI Rule, etc.
Conclusion of Substantial Equivalence: Overall evaluation confirms substantial equivalence.	"The overall technology characteristics and evaluations lead to the conclusion that the Skyway Anterior Cervical Plate System is substantially equivalent to the predicate device."

2. Sample size 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 for this type of submission. No performance testing on a "test set" of clinical data or patient outcomes was conducted or required. The review focused on engineering changes and regulatory compliance.
Data Provenance: Not applicable. The "study" was a regulatory review of engineering specifications and manufacturing process changes (sterilization adoption), not a data-driven performance study.

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)

Number of Experts & Qualifications: Not applicable. Given "No performance testing was required," there was no "test set" requiring ground truth establishment by clinical experts in the context of device performance. The experts involved would be FDA reviewers (e.g., Engineer & Regulatory Specialist Nathan Wright from KMTI, and the FDA's Division of Spinal Devices staff like Colin O'Neill and Maziar Shah Mohammadi), who assess regulatory compliance and engineering specifications against predicate devices.

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

Adjudication Method: Not applicable. There was no "test set" of performance data requiring adjudication. The FDA's review process serves as the "adjudication" against regulatory standards and comparison to predicate devices.

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

MRMC Study: No. This device is not an AI-powered diagnostic tool. It is a physical implant (spinal plate system). Therefore, an MRMC study and AI assistance effect size are not applicable.

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

Standalone Performance: No. This device is a physical implant, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission relates to established engineering principles, material science standards (e.g., ASTM F136 for titanium alloy), and regulatory requirements (e.g., ISO 17665-1 for sterilization). The substantial equivalence claim is the ultimate "ground truth" sought.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. No AI model training was involved for this physical medical device.

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

Ground Truth for Training Set Establishment: Not applicable. No AI model training was involved.

Summary of this Specific 510(k):

This 510(k) clearance (K250486) is a "Special 510(k)" for minor modifications to an existing, already-cleared device. Its purpose is to assure the FDA that changes (adding non-sterile options, minor geometric changes) do not alter the previously established safety and efficacy profiles. Therefore, it does not involve the kind of performance studies, particularly those related to AI model validation, that the questions typically imply. The core "study" is the demonstration of substantial equivalence through regulatory and engineering assessment, not a clinical trial or AI performance evaluation.

Summary

FDA 510(k) Clearance Letter - Skyway Anterior Cervical Plate System

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 10, 2025

Kyocera Medical Technologies, Inc. (KMTI)
℅ Nathan Wright
Engineer & Regulatory Specialist
Empirical Technologies
4628 Northpark Drive
Colorado Springs, Colorado 80918

Re: K250486
Trade/Device Name: Skyway Anterior Cervical Plate System
Regulation Number: 21 CFR 888.3060
Regulation Name: Spinal Intervertebral Body Fixation Orthosis
Regulatory Class: Class II
Product Code: KWQ, OVE
Dated: March 11, 2025
Received: March 11, 2025

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 (the 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 available 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.

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K250486 - Nathan Wright
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250486 - Nathan Wright
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assistance/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,

Maziar Shah Mohammadi

For: Colin O'Neill, M.B.E.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250486

Device Name
Skyway Anterior Cervical Plate System

Indications for Use (Describe)

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

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.

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K250486 510(K) SUMMARY

Submitter's Name: Kyocera Medical Technologies, Inc. (KMTI)
Submitter's Address: 1289 Bryn Mawr Avenue, Suite A
Redlands, California 92374
Submitter's Telephone: 909-557-2360
Contact Person: Nathan Wright, MS, RAC
Empirical Technologies
1-719-351-0248
nwright@empiricaltech.com
Date Summary was Prepared: February 19, 2025
Trade or Proprietary Name: Skyway Anterior Cervical Plate System
Device Classification Name: Spinal Intervertebral Body Fixation Orthosis, Intervertebral Fusion Device with Integrated Fixation, Cervical
Classification & Regulation #: Class II per 21 CFR §888.3060, 21 CFR §888.3080
Product Code: KWQ, OVE
Classification Panel: Orthopedic – Spinal (DHT6B)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

K250486
Page 1 of 2

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K250486
Page 2 of 2

TECHNOLOGICAL CHARACTERISTICS

The subject Skyway Anterior Cervical Plate System has been updated from its previous clearances under K231766 and K243015 to add non-sterile packaged plate options in this submission which were previously only sterile packaged and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes. There are no differences between the subject and predicate device which raise questions for safety and efficacy.

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K243015	Skyway Anterior Cervical Plate System	Kyocera Medical Technologies, Inc.	KWQ, OVE

PERFORMANCE DATA

The modification to offer non-sterile plates was evaluated to determine that the sterilization set for the subject non-sterile devices is adopted into the sterilization adoption per ISO 17665-1 of a worst-case sterilization set. No performance testing was required for this 510(k).

CONCLUSION

The overall technology characteristics and evaluations lead to the conclusion that the Skyway Anterior Cervical Plate System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.