The 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, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Device Description

The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cervical Plate System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Test)	Reported Device Performance
Static compression bending per ASTM F1717	"sufficient for its intended use"
Static torsion per ASTM F1717	"sufficient for its intended use"
Dynamic compression bending per ASTM F1717	"sufficient for its intended use"

Note: The document states that the mechanical performance data leads to the conclusion that the device is "substantially equivalent" to the predicate device. However, it does not explicitly provide numerical acceptance criteria or specific numerical results for these tests. It only states that the device's strength is "sufficient" and comparable to predicate devices.

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The studies mentioned are mechanical performance tests (in vitro), not clinical studies involving human patients or data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

4. Adjudication Method for Test Set

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a physical medical device (Cervical Plate System) through in vitro testing, not on evaluating the effectiveness of an AI algorithm or human reader performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device described is a physical implant (Cervical Plate System), not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by ASTM F1717 standards for static and dynamic mechanical properties of spinal intervertebral body fixation orthoses. The document states "The Cervical Plate System has been tested in the following test modes: - Static compression bending per ASTM F1717 . - Static torsion per ASTM F1717 ● - Dynamic compression bending per ASTM F1717".

8. Sample Size for Training Set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI or machine learning system that requires training data.

9. How Ground Truth for Training Set Was Established

This information is not applicable for the same reason as above; there is no training set mentioned or implied for this mechanical device.

Summary

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August 25, 2020

Image /page/0/Picture/1 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Eminent Spine, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K201979

Trade/Device Name: Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 15, 2020 Received: July 16, 2020

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 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

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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,

Colin O'Neill, M.B.E. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K201979 Device Name Cervical Plate 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)

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FORM FDA 3881 (7/17)

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5.510(K) SUMMARY

Submitter's Name:	Eminent Spine, LLC
Submitter's Address:	1705 Ohio Dr., Suite 300Plano, TX 75093
Submitter's Telephone:	972-499-3593
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	July 15, 2020
Trade or Proprietary Name:	Cervical Plate System
Common or Usual Name:	Anterior Cervical Plate System
Classification:	Class II per 21 CFR §888.3060Spinal Intervertebral Body Fixation Orthosis
Product Code:	KWQ
Classification Panel:	Orthopedics

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The 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.

TECHNOLOGICAL CHARACTERISTICS

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
Technological Characteristics ●
Materials of manufacture
Sizes

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510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K103068	King Cobra AnteriorCervical Plate	Eminent Spine, LLC	Primary
K133475	Struxxure® AnteriorCervical Plate System	Nexxt Spine	Additional

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Cervical Plate System has been tested in the following test modes:

Static compression bending per ASTM F1717 .
Static torsion per ASTM F1717 ●
Dynamic compression bending per ASTM F1717

The results of this non-clinical testing show that the strength of the Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the 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.