The C-TEK Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C2 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

Device Description

The C-TEK Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole (C-TEK and C-TEK C-Thru) or slotted hole (C-TEK) design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "C-TEK Anterior Cervical Plate System." This filing focuses on establishing substantial equivalence to a predicate device, primarily through material composition, indications for use, and biomechanical performance. It does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria in the manner requested.

The questions in your prompt are geared towards evaluating an AI-powered diagnostic or assistive device, which requires details about:

Statistical performance metrics (sensitivity, specificity, accuracy).
Test and training datasets (size, provenance, ground truth establishment).
Expert involvement (number, qualifications, adjudication).
Comparative effectiveness studies (MRMC, standalone).

Since the C-TEK Anterior Cervical Plate System is a physical implant (spinal intervertebral body fixation orthosis) made of titanium alloy, these types of evaluations are not applicable. The substantial equivalence for this device would be demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility, and sterilization validations, rather than diagnostic performance metrics against a medical imaging dataset.

Therefore, I cannot fulfill your request as the provided text does not contain the information necessary to describe acceptance criteria or a study proving device performance for an AI/algorithmic device. The document is about a hardware medical implant.

Summary

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

JUL 1 9 2004 510(k) SUMMARY

K041794 1 of

SUBMITTED BY

Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618

(949) 453-3200

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Spinal intervertebral body fixation orthosis
Common/Usual Name:	Appliance, Fixation, Spinal Intervertebral Body
Product Classification:	Class II
Proprietary Name:	C-TEK Anterior Cervical Plate System

PREDICATE DEVICE

Predicate device information is included in this premarket notification.

INDICATIONS-FOR-USE

DEVICE DESCRIPTION

NOTE: This device system is intended for anterior cervical intervertebral body fusion only.

COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the C-TEK Anterior Cervical Plate is considered substantially equivalent to the legally marketed predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2004

Ms. Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K041794

Trade/Device Name: C-TEK C-Thru Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 1, 2004 Received: July 2, 2004

Dear Ms. Spielberger:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{2}------------------------------------------------

Page 2 - Ms. Wendy Spielberger

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K64 1794

C-TEK C-Thru Anterior Cervical Plate System Devicc Name:

Indications-For-Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 of General, Restorative, and Neurological Devices

510(k) Number K041799 Page 1 of 1

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.