Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Atlas Spinc Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer is intended for use in the thoracolumbar spine (TI-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors 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 Spacer is also indicated for treating fractures of the thoracic and lumbar spine.

The Atlas Spine Spacer 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 Spacer 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 Spacer is a rectangular, radiolucent device in various sizes. The device design includes four radiopaque markers, two on the superior surface and two on the inferior surface, in opposing corners, that allow postoperative radiographic confirmation of the device position and orientation.

AI/ML Overview

This 510(k) summary describes a medical device, the Atlas Spine Spacer, which is an intervertebral body fusion device and a vertebral body replacement. It is a traditional medical device, not an AI/ML software device. Therefore, the questions related to AI/ML software performance criteria, ground truth establishment, sample sizes for training/test sets, and expert involvement are not applicable here.

The document indicates that the device's acceptance criteria and performance were established through pre-clinical data per ASTM F2077, demonstrating substantial equivalence to previously cleared devices.

Here's a breakdown of the provided information, focusing on the relevant parts for a non-AI/ML device:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Shown to be substantially equivalent to K063464 and K072226
Same Indications for Use as Predicate Devices	Has the same indications for use as predicate devices
Same Design as Predicate Devices	Has the same design as predicate devices
Same Function as Predicate Devices	Has the same function as predicate devices
Same Material as Predicate Devices	Has the same material as predicate devices
Biomechanical Performance (per ASTM F2077)	Pre-clinical data per ASTM F2077 submitted to characterize device
Ability to restore biomechanical integrity of spinal column	Designed to restore biomechanical integrity of anterior, middle, and posterior spinal column

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A) for an AI/ML device. The performance data cited is pre-clinical (likely mechanical and material testing), not related to clinical or imaging test sets.

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)

Not Applicable (N/A) for an AI/ML device. Ground truth for device performance is established through engineering and material testing standards (ASTM F2077), not expert consensus on diagnostic interpretations.

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

Not Applicable (N/A) for an AI/ML device. Adjudication methods are typically for clinical diagnostic outcomes or image interpretation, not for mechanical device performance.

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 (N/A). This refers to AI/ML software studies. The Atlas Spine Spacer is a physical implant.

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

Not Applicable (N/A). This refers to AI/ML software studies.

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

For the physical device, the "ground truth" for demonstrating performance is derived from engineering and material testing standards (ASTM F2077), ensuring the device meets predefined mechanical and material properties necessary for its intended use and is comparable to predicate devices. This is not a clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not Applicable (N/A). This refers to AI/ML software development.

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

Not Applicable (N/A). This refers to AI/ML software development.

Summary

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510(k) SUMMARY

OCT - 2 2008

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:	Vice President Regulatory Affairs &Quality Assurance
Telephone:	561-354-4319
Device Classification:	Intervertebral body fusion deviceClass II per 21 CFR §888.3080Product Code: ODP, MAXSpinal intervertebral body fixation orthosisClass II per 21 CFR §888.3060Product Code: MQP
Trade/Proprietary Name:	Atlas Spine Spacer
Common Names:	Intervertebral Body Fusion Device [IBFD]Vertebral Body Replacement [VBR]
Predicate Devices:	Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.K063464IMPIX Interbody DeviceMEDICREA TechnologiesK072226

Intended Use:

Page 1 of 2

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The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer 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 Spacer is also indicated for treating fractures of the thoracic and lumbar spine.

Device Description:

Equivalence to Marketed Product

The Atlas Spine Spacer was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function and material.

Performance Data

Pre-clinical data per ASTM F2077 have been submitted to characterize the Atlas Spine Spacer.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2008

Atlas Spine, Inc. % Ms. Jeannette G. Dailey Vice President Regulatory Affairs & Quality Assurance 1555 Jupiter Park Drive, Suite #4 Jupiter, FL 33458

Re: K081880

Trade/Device Name: Atlas Spine Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 1, 2008 Received: July 8, 2008

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

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Page 2 - Ms. Jeannette G. Dailey

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. 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 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 yours,

Mark M. Wilkerson

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): _ Ko81880

use==========================================================================================================================================================================

Device Name: Atlas Spine Spacer

Indications for Use:

Intervertebral Rody Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use (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)

Page 1 of 1

(Posted November 13, 2003)

Division Sign-O Division of Genera and Neurological Devices

510(k) Number

nono 9 a

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.