The VELOX Anterior Cervical Plate System is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fision of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

· degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

Device Description

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping bone screws using an anterior approach. The VELOX anterior cervical plate, screws and instruments were designed taking into consideration the whole procedure. Plates are available in a variety of lengths, addressing multiple levels of fixation. The VELOX plate incorporates vision ports that allow visualization of post-operative endplate/graft incorporation. Alignment notches on the cephalad and caudal ends of the plate facilitate precise midline placement and allow for Temporary Pin fixation of the plate. To accommodate normal cervical spine lordosis and, at the same time, minimize the need for additional plate contouring, the VELOX Anterior Cervical Plate comes with a pre-machined lordotic curve. Bone screws are available for fixed angle implantation in a variety of lengths.

AI/ML Overview

The VELOX Anterior Cervical Plate is a medical device and is not subject to acceptance criteria in the same way an AI/ML diagnostic or prognostic device would be. Instead, its approval is based on demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Claim)

The "acceptance criteria" for a medical device like this are primarily demonstrating that its design, materials, and mechanical performance are equivalent or superior to predicate devices. The performance is reported in comparison to these predicates.

Acceptance Criteria Category	Reported Device Performance (VELOX ACP System)
Mechanical Performance (ASTM F1717-12)
Static Compression Bending	Results were equal or higher than predicate systems.
Static Torsion	Results were equal or higher than predicate systems.
Dynamic Compression Bending	Results were equal or higher than predicate systems.

Explanation: In the context of a 510(k) submission for a traditional medical device, "acceptance criteria" are implied by the chosen predicate device's established safety and effectiveness. The manufacturer must demonstrate that the new device meets or exceeds the performance of these predicates.

Study Details (Non-Clinical)

Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in terms of the number of specific test articles. However, the study references "testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests" according to ASTM F1717-12. The ASTM standard itself would specify the number of samples required for each test.
- Data Provenance: The testing was conducted by the manufacturer, SpineCraft, LLC, likely in a laboratory setting. The country of origin for the testing is implied to be within the USA, given the submitter's location in Westmont, IL, USA. This is a prospective non-clinical study designed for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical mechanical performance study, not a clinical study involving human patients or expert interpretation of data. "Ground truth" in this context refers to the measured physical properties and performance characteristics determined by the mechanical tests, not expert consensus on medical conditions.
Adjudication method for the test set:
- Not Applicable. As a non-clinical mechanical test, there is no expert adjudication process. The results are quantitative measurements against established engineering standards.
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 device, not an AI/ML algorithm. No human readers or AI assistance are involved in its primary function or testing for regulatory approval.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
The type of ground truth used:
- Mechanical Test Results against ASTM Standards. The "ground truth" for this device's performance is derived from the objective measurements obtained through standardized mechanical testing (ASTM F1717-12). These results are then compared to the known performance of predicate devices.
The sample size for the training set:
- Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set. The design of the device is based on engineering principles and potentially prior experience with similar devices, but not a data-driven training set in the AI sense.
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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K131521 Page 1 of 2

DEC 2 4 2013

510(k) Summary for the VELOX Anterior Cervical Plate

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the VELOX Anterior Cervical Plate

Date Prepared: 5/17/2013

Submitter:

SpineCraft, LLC 777 Oakmont Lane Westmont, IL 60559 USA Tel: 1 630-920-7300 Fax: 1630-920-7310

Contact Person: Ami Akallal-Asaad Director of Requlatory Affairs. SpineCraft, LLC a.asaad@spinecraft.com

Establishment Registration No: Trade name: Common Name: Classification Name:

Product Code: Classification Panel: 3004717358 VELOX Anterior Cervical Plate System Anterior Cervical Plate Spinal intervertebral body fixation orthosis Per 21 CFR 888.3060 KWQ Class II 87

Predicate or legally marketed devices which are substantially equivalent:

Envision Anterior Cervical Plate System (K020649) / Ortho Development ALTUM Anterior Cervical Plate (K103505) / SpineCraft C-Tek MaxAn Anterior Cervical Plate System (K080646) / Biomet Spine UNIPLATE Anterior Cervical Plate (K042544 / K082273 / K100070) / DePuy CLSP Cervical Plate (K000536) / Synthes

Description of the device:

Materials:

Ti-6Al-4V per ASTM F136 CoCr28Mo6 per ASTM F1537

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Function:

The VELOX Anterior Cervical Plate system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion.

Substantial equivalence claimed to predicate devices

VELOX Anterior Cervical Plate system is substantially equivalent to the Envision Anterior Cervical Plate System (K020649), ALTUM Anterior Cervical Plate (K103505) and MaxAn Anterior Cervical Plate System (K080646) in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the VELOX Anterior Cervical Plate system to these predicate devices.

Intended Use:

The VELOX Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7), The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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),
. spondviolisthesis.
trauma (i.e. fractures or dislocations), ●
. tumors,
deformity, .
pseudarthrosis. .
failed previous fusion, .
. spinal stenosis.

Non-clinical Test Summary:

The following tests were conducted:

ASTM F1717-12, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests. The results of this testing were compared to predicate systems, with the results being equal or higher than the predicate systems.

Clinical Test Summary

No clinical studies were performed

Conclusions Nonclinical and Clinical

The VELOX Anterior Cervical Plate System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a person embracing another person.

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 24, 2013

SPINECRAFT, LLC Ms. Ami Akallal-Asaad Director of Regulatory Affairs 777 Oakmont Lane Westmont, lilinois 60559

Re: K131521

Trade/Device Name: VELOX Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 21, 2013 Received: November 26, 2013

Dear Ms. Akallal-Asaad:

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 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

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ﻟﻬﻢ ﻣﻦ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Page 2 - Ms. Ami Akallal-Asaad

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Indications for Use

510(k) Number (if known) K131521

- ...

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Device Name

VELOX Anterior Cervical Plate System

Indications for Use (Describe)

· degenerative disc disease (as defined by neck pain of discogenion of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),

• tumors,

· deformity,

· pseudarthrosis.

· failed previous fusion,

· spinal stenosis.

Type of Use (Select one or both, as applicable)

P Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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: : : : : :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

on E. Dmitriev.

FORM FDA 3881 (9/13)

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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.