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 (scollosis, 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

The provided document is a 510(k) summary for the Vertefix® Pedicle Screw Spinal System, which is a medical device for spinal fixation, not an AI/ML-driven diagnostic or therapeutic device. As such, the concept of "acceptance criteria" based on device performance metrics like sensitivity, specificity, or AUC, and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance, is not applicable here.

Instead, this document describes a traditional medical device submission where "acceptance criteria" would refer to demonstrating substantial equivalence to a legally marketed predicate device through engineering performance testing (e.g., biomechanical testing) and material characterization. The "study" proving acceptance criteria would be these engineering tests.

Here’s an explanation tailored to the information provided for this type of medical device:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Demonstration of Substantial Equivalence:	The Vertefix® Pedicle Screw Spinal System was determined to be substantially equivalent to the following predicate devices: OPTIMA™ Spinal System (K051971), Denali™ Spine System (K042635), and XIA™ Spine System Hooks (K001319).
* Design, Function, Materials, Operational Principles, and Intended Use: No significant differences compared to predicate devices that would adversely affect use.	The device's design, function, materials, operational principles, and intended use were deemed substantially equivalent to the predicate devices and other currently marketed spinal fixation systems.
* Biomechanical Performance: Compliance with ASTM F1717 for spinal implant constructs.	Biomechanical testing in accordance with ASTM F1717 demonstrated substantial equivalence to the predicate systems and other marketed systems.
* Material Composition: Fabrication from titanium alloy (Ti-6Al-4v ELI) conforming to ASTM F 136.	Vertefix® Spinal System components are fabricated from titanium alloy (Ti-6Al-4v ELI) that conforms to ASTM F 136.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of device performance in biomechanical testing for spinal implants. The "sample size" would refer to the number of test articles (e.g., pedicle screws, rods) subjected to various mechanical loads as per ASTM F1717. This information is typically detailed in the full test reports, which are not part of this 510(k) summary.
- Data Provenance: Not applicable in the context of biomechanical testing. The tests are conducted under laboratory conditions.
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)
- Not applicable. Ground truth, in the AI/ML context, does not apply to the biomechanical testing of a spinal implant. The "ground truth" for this device is established by engineering standards (e.g., ASTM F1717) and material specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for clinical or interpretation studies, not for the biomechanical assessment of a physical device.
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 not an AI/ML device, and no MRMC study would be performed for a spinal fixation system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this device, the "ground truth" for demonstrating safety and effectiveness lies in its adherence to established engineering standards (like ASTM F1717) for biomechanical performance and material standards (like ASTM F136) for material composition, as well as its substantial equivalence in design and intended use to predicate devices already on the market.
The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.

Summary

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K063453

AUG 3 0 2007

SECTION 4 - 510(k) SUMMARY

[As required by 21CFR807.92]

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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

Elite Surgical Supplies Vertefix® Pedicle Screw Spinal System

Page 4-1

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

October 4, 2006

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

CompanyName:	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	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 § 888.3070Spondylolisthesis SpinalFixation Orthosis (MNH)per 21 CFR § 888.3070Spinal InterlaminalFixation Orthosis (KWP)Per 21 CFR § 888.3050
Device Class:	Class II
Product Code:	MNI, MNH, KWP

man and the state

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

PREDICATE DEVICES
U and I Corporation, OPTIMA™ Spinal System
MNI, MNH, KWQ
(K051971)
K2M Inc, Denali™ Spine System
KWP, MNH, MNI
(K042635)
Howmedica Osteonics Corp. XIA™ Spine System Hooks
MNH
(K001319)

There are no significant differences between the Vertefix® Pedicle Screw Spinal System and the OPTIMA™ System, the Denali146 Spine System, the XIATM Spine System Hooks, 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)]

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

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

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

The Vertefix® Pedicle Screw Spinal System components were biomechanically tested in accordance with 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, 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 F 136. Various sizes of these implants are available for the application.

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Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2007

Elite Surgical Supplies (Pty) Ltd. % Ms. Charise De Barros Agent 503 Commerce Park Drive SE, Suite i Marietta, GA 30060

Re: K063453 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: August 6, 2007 Received: August 9, 2007

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chabane Buelun

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

Enclosure

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SECTION 3 - INDICATIONS FOR USE

Elite Surgical Supplies (Pty) Ltd Applicant K063453 510(k) Number (if known) Vertefix® Pedicle Screw Spinal System Device Name

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

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

OR Over-the-Counter Use_ Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harbare Buclus

Division of General, Restorative, and Neurological Devices

510(k)Number K063453

dicle 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.