The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) 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. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Device Description

The Atlas Spine VBR is generally rectangular in shape with anterior and posterior walls that are concentric arcs. The device is available in various sizes with an anterior height ranging from 10mm to 18mm and anterior width of 28mm while providing 0 or 5 degrees of lordosis. The posterior aspect is tapered, or bulleted, for ease of insertion. All devices are 20.0mm in length. The device design includes four radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

AI/ML Overview

This document describes a 510(k) premarket notification for the Atlas Spine Vertebral Body Replacement (VBR) device. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials or detailed performance studies to establish acceptance criteria for novel device performance.

Therefore, many of the requested elements for a study proving device performance (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not typically present or required in a 510(k) submission for a device demonstrating substantial equivalence. The primary "study" is often a comparison of the new device's design, materials, and intended use against a legally marketed predicate device.

Based on the provided text, here's what can be extracted and what cannot:

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

This information is not provided in the document. A 510(k) for substantial equivalence usually doesn't specify new, quantifiable acceptance criteria for device performance beyond meeting the characteristics of the predicate device. The "performance" demonstrated is that the device is substantially equivalent to the predicate.

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 provided because a specific "test set" in the context of a new performance study (e.g., clinical trial) is not described. The submission relies on a comparison to a predicate device.

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 provided. Ground truth established by experts is not relevant in this 510(k) context.

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

This information is not provided.

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 provided. An MRMC study is not relevant to this type of device and submission. The device is a physical spinal implant, not an AI diagnostic tool.

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

This information is not provided. This refers to AI algorithms, which is not applicable here.

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

This information is not provided.

8. The sample size for the training set:

This information is not provided. Training sets are generally associated with machine learning models, which are not applicable to this physical device submission.

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

This information is not provided.

Summary of what is present in the document relevant to how the device meets "acceptance criteria" (understood here as "criteria for substantial equivalence"):

The document argues that the Atlas Spine VBR meets the acceptance criteria for substantial equivalence through a comparison to its predicate device, Atlas Spine Vertebral Body Replacement (K063464).

Here's how the "study" (the 510(k) submission) proves the device meets these criteria:

Intended Use: The intended use of the Atlas Spine VBR is directly compared and found to be "substantially the same" as the predicate device. Both are for use in the thoracolumbar spine (T1-L5) for partial or complete replacement of a diseased vertebral body (tumors, fractures) to achieve decompression, restore height, and maintain biomechanical integrity. Both are intended to be used with supplemental spinal fixation systems and packed with bone.
Design: The device's design (generally rectangular, anterior and posterior walls with concentric arcs, various sizes: 10mm-18mm anterior height, 28mm anterior width, 0 or 5 degrees lordosis, 20.0mm length, tapered posterior aspect, four radiopaque markers) is presented and compared against the predicate as being "substantially the same" in design principles.
Materials: Both the subject device and the predicate devices are made from implantable PEEK (polyetheretherketone) polymer, establishing material equivalence.
Functional Characteristics: It is stated that the "functional characteristics... are substantially the same." Both systems provide support after resection/removal of a damaged/collapsed/unstable vertebral body and are complemented by supplemental internal fixation.

Conclusion from the document:

The FDA reviewed the 510(k) submission (K071497) and determined that the Atlas Spine Vertebral Body Replacement is substantially equivalent to legally marketed predicate devices, thereby allowing it to be marketed. This determination implies that the device "meets the acceptance criteria" as defined by the 510(k) process for substantial equivalence.

Summary

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Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement

510(k) SUMMARY

Manufacturer:	Atlas Spine, Inc.
Address:	1555 Jupiter Park Drive, Suite #4Jupiter, FL 33458
Telephone:	561-741-1108
Fax:	561-741-1870
Official Correspondent:	Jeannette G. Dailey
Title:	VP Regulatory Affairs
Telephone:	561-354-4319
Device ClassificationName:	Spinal intervertebral body fixation orthosis
Trade/Proprietary Name:	Atlas Spine Vertebral Body Replacement
Common Name:	Spinal vertebral body replacement device
Classification:	Class II per 21 CFR §888.3060
Product Code:	MQP
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Device:	Atlas Spine Vertebral Body ReplacementK063464

Intended Use:

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Device Description:

Equivalence to Marketed Product

Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine VBR is substantially equivalent in indications and design principles to the 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. 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 the predicate devices are made from implantable PEEK [polyetheretherketone] polymer.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Atlas Spine, Inc. % Mrs. Jeannette Dailey Vice President, Regulatory Affairs 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458

Re: K071497

Trade/Device Name: Atlas Spine Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 30, 2007 Received: May 31, 2007

Dear Mrs. 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 mav 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 - Mrs. Jeannette 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) 2760-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours

Enclosure

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Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Vertebral Body Replacement

Indications for Use

510(k) Number (if known):

Device Name: Atlas Spine Vertebral Body Replacement

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number	1071497
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(Posted November 13, 2003)

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.