The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scoliosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Removal of the implants after the attainment of a solid fusion is optional.

Device Description

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.
The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

AI/ML Overview

This document describes a 510(k) premarket notification for the Vertefix® Pedicle Screw Spinal System, seeking to demonstrate substantial equivalence to a predicate device. As such, the study design focuses on comparative performance against the predicate rather than establishing novel acceptance criteria and reporting performance for an AI-powered device.

Therefore, many of the typical questions for AI acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's an attempt to address the relevant points based on the provided text, and explicitly state when information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Mechanical Performance	Substantial Equivalence to Predicate Device for Construct Testing (ASTM F1717)	"This testing demonstrated substantial equivalence to the predicate systems and other marketed systems."	Original Vertefix system met this. For the modified system (5.5mm rod), specific testing was not repeated because the change was expected to improve performance, but thread pullout testing was performed.
Material Properties	Conformance to ASTM F136 for Titanium alloy (Ti-6Al-4V ELI)	"The Vertefix® Spinal System components are fabricated from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136."	This ensures material safety and performance.
Design and Function	Substantial Equivalence to Predicate Device in terms of intended use, operating principle, and design.	"Further comparison to the predicates also demonstrated substantial equivalence in terms of intended use, operating principle, materials, shelf life and design."	Confirms fundamental similarity to existing, approved devices.
Thread Design Strength	Adequate pullout strength (no specific numerical criteria given)	"Thread pullout testing was however performed to prove the thread design."	This was done for the modified system with the 5.5mm rod.
Safety and Effectiveness	No significant differences that would adversely affect product use compared to predicate.	"There are no significant differences between the Vertefix® Pedicle Screw Spinal System and the approved Vertefix® Pedicle Screw Spinal System or other spinal fixation systems currently being marketed, which would adversely affect the use of the product."	This is the overarching criterion for 510(k) substantial equivalence.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This is a mechanical device, not an AI/software device that uses "data" in the typical sense for a test set. The "testing" referred to is mechanical testing of physical components (e.g., construct testing per ASTM F1717, thread pullout testing). The sample size for these mechanical tests is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of an AI device typically refers to clinical diagnosis or outcome verified by experts. For a mechanical implant device, the "ground truth" is defined by established engineering standards (like ASTM F1717) and successful performance in those tests. Expert consensus for clinical diagnosis is not relevant here.

4. Adjudication method for the test set

Not Applicable. Adjudication methods are relevant for subjective interpretations of data, particularly in clinical assessments where multiple readers might disagree. For mechanical testing against objective standards, adjudication is not a standard practice.

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

Not Applicable. This is a mechanical spinal implant system, not a diagnostic or prognostic AI tool that would assist human readers.

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

Not Applicable. This is a mechanical device. There is no algorithm.

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

The "ground truth" for this device's performance is established by conformance to recognized industry standards (e.g., ASTM F1717) for mechanical testing and the material specifications (ASTM F136). The equivalence to a predicate device, which has already established safety and efficacy through its own testing and clinical use, serves as the primary benchmark.

8. The sample size for the training set

Not Applicable / Not Provided. As a mechanical device, there is no "training set" in the computational sense. The design and testing are based on engineering principles and performance standards, not machine learning.

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

Not Applicable. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Vertefix® Pedicle Screw Spinal System meets its acceptance criteria is primarily a bench-top mechanical evaluation demonstrating substantial equivalence to a legally marketed predicate device.

Original System Testing: The original Vertefix® Pedicle Screw Spinal System underwent construct testing according to ASTM F1717. This testing demonstrated "substantial equivalence to the predicate systems and other marketed systems" in terms of mechanical performance.
Material Conformance: The components are fabricated from Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136, which establishes material quality and safety.
Modified System Justification: For the modified system (with a 5.5mm rod), a full re-test against ASTM F1717 was not performed. The rationale provided was that this change was expected to "perform slightly better than the already tested Vertefix Spinal System." However, thread pullout testing was performed specifically to "prove the thread design" of the modified system.
Comparative Analysis: A comparative analysis against various predicates (including the original Vertefix system) was performed, concluding that there are "no significant differences... which would adversely affect the use of the product" in terms of design, function, materials, operational principles, and intended use.

In essence, the "study" for this 510(k) submission is a combination of prior mechanical testing, material standardization, and a reasoned argument supported by specific additional testing (thread pullout) and comparative analysis to demonstrate that the new device is as safe and effective as a legally marketed predicate.

Summary

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

K080075

SECTION 4

JAN 28 2008

SECTION 4 - 510(k) SUMMARY

[As required by 21CFR807.92]

Image /page/0/Picture/5 description: The image shows a series of horizontal lines and patterns. There are six distinct rows, each containing a different arrangement of dark and light areas. The top and bottom rows feature solid dark bars, while the middle rows display more complex, textured patterns with varying densities of dark and light elements.

ELITE SURGICAL SUPPLIES (PTY) LTD

P.O. Box 26115 Arcadia Pretoria 0007 South Africa

Contact Person: John O'Toole Contact Title: Managing Director Tel: +27 12 386 0012 Fax: +27 12 386 2745 Email: john@elitesurgical.com

(Please notify via email of correspondence with the Submission correspondent)

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System Page 4-1

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

4.1 Date Prepared [21CFR807.92(a)(1)]

November 16, 2007

4.2 Submitter's Information [21CFR807.92(a)(1)]

Company Name:	Elite Surgical US
Street Address:	503 Commerce Park Drive, Suite I
City:	Marietta
State/Province:	Georgia
Country:	USA
Telephone:	404-408-2396
Facsimile:	770-590-5152
Contact Person:	Charise de Barros
Contact Title:	Agent
Contact Email:	Charise@EliteSurgicalUSA.com

4.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]

Trade Name:	Vertefix® Pedicle Screw SpinalSystem
Common Name:	Pedicle Screw Spinal FixationSystem
Classification Name:	Spinal Pedicle ScrewFixation Orthosis(MNI)per 21 CFR § 888.3070
	Spondylolisthesis SpinalFixation Orthosis (MNH)per 21 CFR § 888.3070
	Spinal InterlaminalFixation Orthosis (KWP)Per 21 CFR § 888.3050
Device Class:	Class II
Product Code:	MNI, MNH, KWP

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System

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

4.4 Identification of Predicate Device(s) [21CFR807.92(a)(3)[

יין///---1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Screw Systemכחומרerteti
18062452------------------------------------------------------------------------------------------------------------------------------------------------------------------------------RE REGIONAL PROPERTY----------

There are no significant differences between the Vertefix® Pedicle Screw Spinal System and the approved Vertefix® Pedicle Screw Spinal System or other spinal fixation systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials, operational principles and intended use.

4.5 Description of the Device [21CFR807.92(a)(4)]

The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

4.6 Intended Use [21CFR807.92(a)(5)]

Removal of the implants after the attainment of a solid fusion is optional.

4.7 Technological Characteristics [21CFR807.92(a){6)]

The original Vertefix® Pedicle Screw Spinal System components were submitted to construct testing according to ASTM F1717.This testing demonstrated substantial equivalence to the predicate systems and other marketed systems. Further comparison to the predicates also demonstrated substantial equivalence in terms of intended use, operating principle, materials, shelf life and design. There are no significant differences between the Vertefix® spinal system, the predicate device,

Elite Surgical Supplies

Vertefix® Pedicle Screw Spinal System

Page 4-3

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

and other systems currently marketed which would adversely affect the use of the product. The Vertefix® Spinal System components are fabricated from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available for the application. The modified system was not again submitted to the ASTM F1717 testion, as the only significant change to the system is the change to a 5.5mm rod. This will make the system perform slightly better than the already tested Vertefix Spinal System. Thread pullout testing was however performed to prove the thread design.

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System Page 4-4

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elite Surgical Supplies Ltd. % Elite Surgical US Ms. Charise De Barros 503 Commerce Park Drive SE, Suite I Marietta, GA 30060

Re: K080075

Trade/Device Name: Vertefix® Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: November 16, 2007 Received: January 11, 2008

Dear Ms. De Barros:

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.

{5}------------------------------------------------

Page 2 - Ms. Charise De Barros

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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milburn

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE

Applicant 510(k) Number (if known) Device Name

Elite Surgical Supplies (Pty) Ltd K080075 Vertefix® Pedicle Screw Spinal System

Indications for Use: The Vertefix® Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine, for the following indications:

. Spondylolisthesis;
. Trauma (e.g. fracture or dislocation):
. Spinal stenosis;
Deformities or curvatures (scoliosis, kyphosis and lordosis); .
. Tumor;
. Pseudoarthrosis; and
Failed previous fusion. ●

Prescription Use OR Over-the-Counter Use X (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(Divi n Sign-Off) Division of General, Restorative, and Necrological Devices

510(k) Number

80078

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System Page 3-1

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.