The King Cobra™ 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.

Device Description

The King Cobra™ Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter- length combinations. Plates are available in a variety of lengths.

AI/ML Overview

The provided text describes the "King Cobra™ Cervical Plate System" and its substantial equivalence to a predicate device, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like acceptance criteria for algorithmic performance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable here.

However, I can extract the information related to the device's technical characteristics and the study performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, "acceptance criteria" often refer to performance standards met through specific tests. In this case, the device is a spinal plate system, and its performance is evaluated against mechanical testing standards. The acceptance criterion is that the device performs "as well as or better than the predicate device."

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Design	Same basic design as predicate (plate-based fixation with self-tapping screws)	Possesses the same basic design as predicate.
Material	Same material as predicate (titanium alloy (Ti-6Al-4V) per ASTM F136)	Manufactured from titanium alloy (Ti-6Al-4V) as predicate.
Sizes	Plate and screw sizes encompassed by predicate systems	Sizes are encompassed by those offered by predicate systems.
Intended Use	Same intended use as predicate	Same intended use as predicate.
Mechanical Testing	Performs as well as or better than the predicate device according to ASTM F1717	Performed as well as or better than the predicate device.

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

Sample Size: The document does not specify a "sample size" in the context of human data or test sets. The performance data is based on mechanical testing of the "worst case King Cobra™ construct." The specific number of constructs tested is not detailed.
Data Provenance: Not applicable as this is mechanical testing of a medical device, not a study involving human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as this is mechanical testing of a medical device, not a study establishing ground truth with expert review.

4. Adjudication Method

Not applicable.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical medical device, not an AI/ML system or diagnostic tool typically evaluated with such studies.

6. Standalone Performance Study (Algorithm Only)

Not applicable as this is a mechanical medical device.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance was established by ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), which is an industry standard for mechanical testing of spinal implants. The comparison was against the performance of a predicate device.

8. Sample Size for the Training Set

Not applicable as this is a mechanical medical device, not an AI/ML model that requires training data.

9. How Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows a circular logo with the words "EMINENT SPINE" at the top and "BAD TO THE BONE" at the bottom. In the center of the logo, there is an image of a spine with a skull at the top. The logo is black and white and has a vintage or grunge style.

Eminent Spine, LLC

7200 N 11t 35 Bldg. 1 Georgetown, TX 78626 Phone: (512) 868-5980 Fax: (512) 864-1462

JAN 1 4 2011

8. 510(k) Summary

Date:	15 October 2010
Sponsor:	Eminent Spine LLC 7200 N I-35 Building #1 Georgetown, TX 46037 Phone 512-868-5980 Fax 512-864-1462
Contact Person:	Dave Freehill, President
Proposed Trade Name:	King Cobra™ Cervical Plate System
Device Classification	Class II
Classification Name:	Spinal intervertebral body fixation orthosis
Regulation:	888.3060
Device Product Code:	KWQ
Device Description:	The King Cobra™ Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter- length combinations. Plates are available in a variety of lengths.
Intended Use:	The King Cobra™ 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.
Materials:	The King Cobra™ Cervical Plate System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
Predicate Devices:	Cervical Spine Locking Plate (K945700/K030866)

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Technological Characteristics:

The King Cobra™ Cervical Plate System possesses the same technological characteristics as the predicate. These include

basic design (plate-based fixation system having self-tapping . screws in various sizes),
material (titanium alloy), .
sizes (plate and screw sizes are encompassed by those offered . by the predicate systems) and
intended use (as described above). .

The fundamental scientific technology of the King Cobra™ is the same as the previously cleared device.

Performance Data: Static compression bending and torsion, and dynamic compression bending of the worst case King Cobra™ construct was performed
according to ASTM F1717. The mechanical test results demonstrated that King Cobra™ performs as well as or better than the predicate device.

Page 15

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Eminent Spine, LLC % Backroads Consulting, Inc. Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141

JAN 1.4 2017

Re: K103068

Trade/Device Name: King Cobra™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 15, 2010 Received: October 18, 2010

Dear Dr. Warden:

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. 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

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Page 2 - Karen E. Warden, Ph.D.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf DA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Indications for Use Statement

510(k) Number:_K10 3068

Device Name: King Cobra™ Spinal System

Indications for Use:

The King Cobra™ 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.

Prescription Use X

AND/OR

Over-the-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Or hopedic, and Restorative Devices

510(k) Number_K103068

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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.