The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine VBR can be packed with bone. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

Device Description

The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumber vertebral body after complete or partial vertebrectomy.

The device design includes radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

AI/ML Overview

The provided text is a 510(k) summary for the Atlas Spine Vertebral Body Replacement device, which is a medical implant. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study design for performance evaluation.

Therefore, the document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria as typically expected for a diagnostic AI/ML device or a device requiring new clinical performance data.

The device, the Atlas Spine Vertebral Body Replacement (VBR), is a physical implant, not a diagnostic or AI-driven system. Its clearance is based on substantial equivalence to predicate devices. This means that its safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's a breakdown based on the categories you requested, highlighting why most of the information is not applicable to this type of submission:

A table of acceptance criteria and the reported device performance:
- N/A. The submission does not define specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, etc., nor does it report performance in that manner. The "performance" is implicitly deemed equivalent to the predicate devices through design, material, and intended use comparison.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. There is no "test set" in the context of evaluating performance for a new diagnostic algorithm or a device requiring specific clinical performance data. The device's safety and effectiveness are assessed through its substantial equivalence to existing devices.
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):
- N/A. No ground truth establishment by experts is described as this is not a diagnostic device and no new clinical performance study requiring such ground truth is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no test set or clinical performance study described.
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:
- N/A. This device is a physical spinal implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physical spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No ground truth is established or used in this submission beyond the demonstration that the device's design, materials, and intended use are substantially equivalent to a predicate device.
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no training set mentioned or applicable.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set.

In summary, the provided 510(k) summary for the Atlas Spine Vertebral Body Replacement device focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a performance study with acceptance criteria, test sets, or ground truth as would be relevant for a diagnostic or AI-driven medical device undergoing a different type of review.

Summary

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Atlas Spine Vertebral Body Replacement

510(k) Summary

Atlas Spine

FEB 2 6 2007

Atlas Spine Vertebral Body Replacement

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Atlas Spine, Inc. 1555 Jupiter Park Dr., #4 Jupiter, FL 33458 Telephone (561) 741-1108 Fax (561) 741-1870

Official Contact:

Representative/Consultant:

Jeannette G. Dailey

Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego. CA 92130 Telephone (858) 792-1235 Fax (858) 792-1236

DEVICE NAME

Classification Names: Spinal intervertebral body fixation orthosis Trade/Proprietary Name: Atlas Spine Vertebral Body Replacement

Common Name:

Spinal vertebral body replacement device

DEVICE CLASSIFICATION

FDA has classified spinal intervertebral body fixation orthoses as Class II devices (21CFR 888.3060). The product code for spinal vertebral body replacement device is MQP. These devices are reviewed by the Orthopedic Spine Devices Branch.

INTENDED USE

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510(k) Summary

K66 3205

height of a collapsed vertebral body. The Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine.

DEVICE DESCRIPTION

The device design includes radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

EQUIVALENCE TO MARKETED PRODUCT

Atlas Spine, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Atlas Spine VBR is substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.

The intended use, design, materials and functional characteristics of the Atlas Spine VBR and the predicate devices are substantially the same. The height, width, length, and lordotic angle of Atlas Spine VBR are within the ranges available for one or more of the predicate devices. Each system is intended to be used to provide support after resection or removal of a damaged, collapsed, or unstable vertebral body due to tumor, fracture, or other disease. The subject device and predicate devices are placed within the area of removed or resected spine and are functionally complemented by supplemental internal fixation. The subject device and the predicate devices are intended to be used with bone graft. The Atlas Spine VBR and predicate devices are made from implantable PEEK polyetheretherketone) polymer.

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2007

Atlas Spine Inc. % Ms. Jeannette G. Dailey Vice President, Regulatory Affairs 1555 Jupiter Park Dr., Suite #4 Jupiter, Florida 33458

Re: K063205

Trade/Device Name: Atlas Spine Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 19, 2007 Received: January 22, 2007

Dear Ms. Dailey:

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.

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Page 2 - Ms. Jeannette G. Dailey

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark McMullen

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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Indications for Use

510(k) Number (if known): K()63205

Device Name: Atlas Spine Vertebral Body Replacement

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millenson

(Division Sign-Off) Division of General, Restorative, on Neurological Devices

310(k) Number

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.