When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the PROTEX™ CT Spinal System is indicated for: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The PROTEX™ CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX™ System, using parallel connectors.

Device Description

The PROTEX™ CT Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, and occipital clamps. The implants are composed of titanium alloy.

AI/ML Overview

This document is a 510(k) summary for the PROTEX™ CT Cervicothoracic Spinal System, a medical device. It focuses on mechanical testing for performance evaluation, not on AI/ML device performance. Therefore, most of the requested information regarding acceptance criteria for AI, study design for AI models, and ground truth establishment is not applicable.

Here's the relevant information based on the provided text:

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

The document states: "Mechanical testing was conducted to evaluate performance as a basis for substantial equivalence." However, it does not explicitly list the acceptance criteria or the specific numerical results of this mechanical testing within the provided text. To determine the acceptance criteria, one would typically refer to the full mechanical testing report that was submitted with the 510(k), which is not included here. The "reported device performance" is implied to have met the necessary thresholds for substantial equivalence to predicate devices, allowing for clearance.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text, but implied to be mechanical performance thresholds for substantial equivalence to predicate devices.	Not explicitly stated in the provided text, but implied to have met the necessary thresholds for substantial equivalence.

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

This information is not applicable as the document describes a mechanical device and its testing, not an AI/ML-based device that would utilize a test set of data.

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)

This information is not applicable for the same reason as above. Ground truth establishment is relevant for algorithm performance validation, not for mechanical device testing.

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

This information is not applicable.

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

This information is not applicable.

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

This information is not applicable.

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

This information is not applicable. The "ground truth" for a mechanical device is typically its physical properties and performance under stress, which are measured directly.

8. The sample size for the training set

This information is not applicable as this is a mechanical device, not an AI/ML model that undergoes training.

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

This information is not applicable.

Summary

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

K056391 9/2

JUL 2 1 2005

= 510(K) Summary

SUBMITTED BY:

Globus Medical Inc. 303 Schell Lane Phoenixville, PA 19460 (610) 415-9000 x218 Contact: Kelly J. Baker

DATE PREPARED:

February 15, 2005

DEVICE NAME:

PROTEX™ CT Cervicothoracic Spinal System

CLASSIFICATION:

Per CFR as follows: 21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis 21 CFR §888.3070 Pedicle Screw Spinal System Product codes KWP and MNI. Panel code is 87. Device classification Class II.

PREDICATE DEVICES:

Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675)

DEVICE DESCRIPTION:

INTENDED USE:

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

Koscill 1½

fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The PROTEX™ CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEX™ System, using parallel connectors.

PERFORMANCE DATA:

Mechanical testing was conducted to evaluate performance as a basis for substantial equivalence.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines representing movement or progress.

Public Health Service

JUL 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kelly Baker, Ph.D. Project Manager, Regulatory Affairs Globus Medical, Inc. 303 Schell Lane Phoenixville, Pennsylvania 19460

Re: K050391

Trade/Device Name: PROTEX™ CT Cervicothoracic Spinal System Regulation Number: 21 CFR 888.3070 and 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system and Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP and MNI Dated: July 8, 2005 Received: July 11, 2005

Dear Dr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allu Cosmetic rice (71ct) that to not requent to the general controls provisions of the Act. The Tou may, therefore, thanks of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 it may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Could cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drive issuates of your device complies with other requirements of the Act that I Dri has made a acterinalations administered by other Federal agencies. You must or any I catales and 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 CI K I at 607), laboring (21 CFR Part 820); and if applicable, the electronic forth in the quality by tickles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Kelly Baker, Ph.D.

This letter will allow you to begin marketing your device as described in your section 510(k) I his letter will anow you to obgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarked notification. "The PDT Intamg of casification 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 If you desire specific advice for your act (240) 276-0120 . Also, please note the regulation entitled, p contact the Office of Comphance at (210) = + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misbranding by reference to premarket notification (in i se Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Abouter Provinces on on the Propport/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement II.

510(k) Number:	K050391
Device Name:	PROTEX™ CT Cervicothoracic Spinal System

Indications:

When intended to promote fusion of the cervical spine and occipito-cervicothoracic junction (occiput-T3), the PROTEX™ CT Spinal System is indicated thorable junotion (oose ase (as defined by neck pain of discogenic origin for: degenerative also also confirmed by patient history and radiographic win't degeneration of the is, spinal stenosis, fracture, dislocation, atlanto/axial Studies), Spondylollothools, Spinal real dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed (11-19) in trouting theracted bone screws are limited to occipital fixation; they in the our noal of fixation of the posterior cervical spine.

The PROTEX™ CT System can also be linked to titanium rod systems ranging The PROTEX - GT System Smm, including the PROTEX™ System, using parallel connectors.

Prescription Use × (Per 21 CFR §801.109) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. A.

Siston Sign-Off) Tivision of General, Restorative ad Neurological Devices

113 Minininer_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.