The Atlas Spine Pivoting System is indicated for spinal 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 level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.

Device Description

The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.

AI/ML Overview

The provided text describes the Atlas Spine Pivoting System, an intervertebral body fusion device. The document primarily focuses on its substantial equivalence to predicate devices for 510(k) clearance, rather than a detailed performance study with acceptance criteria and results.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it mentions that "Pre-clinical, mechanical testing was performed… in accordance with ASTM F-2077 and ASTM F-2267." The conclusion states that "Provided documentation demonstrates that the Atlas Spine Pivoting System is substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This implies that the device met performance standards rather than specific, pre-defined acceptance criteria with quantified results within this document.

If we were to infer the "acceptance criteria" from the statement about substantial equivalence, it would be that the mechanical performance (static axial compression, expulsion, subsidence, dynamic axial compression) of the Atlas Spine Pivoting System is comparable to that of legally marketed predicate devices, as assessed by complying with ASTM F-2077 and ASTM F-2267. However, the specific numerical targets and results are not provided in this summary.

Acceptance Criteria (Inferred)	Reported Device Performance (Implied)
Mechanical performance, including static axial compression, expulsion, subsidence, and dynamic axial compression, must meet standards equivalent to legally marketed predicate devices.	"Pre-clinical, mechanical testing was performed on the Atlas Spine Pivoting System. Testing consisted of static testing in a load to failure mode in axial compression; static testing in expulsion; static testing in subsidence; and dynamic axial compression testing to estimate the maximum run out load. Testing was performed in accordance with ASTM F-2077 and ASTM F-2267. Data have been submitted to characterize the performance of the Atlas Spine Pivoting System."
Design, materials, and functional characteristics must be substantially similar to legally marketed predicate devices.	"The intended use, design, materials and functional characteristics of the Atlas Spine Pivoting System and the predicate devices are substantially the same. The height, width, length and lordotic angles of the Atlas Spine Pivoting implant are within the ranges available for the predicate devices."
Indication for Use must be substantially similar to legally marketed predicate devices.	"This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." (Referencing comparison to Novel® Spinal Spacer System, Atlas Spine Spacer, Pivotec Lumbar Interbody Fusion Device).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the mechanical testing. The document states "Testing consisted of static testing..." and "dynamic axial compression testing," implying multiple tests were run, but the number of devices or test iterations is not provided.
Data Provenance: The testing was "Pre-clinical, mechanical testing" performed by the manufacturer, Atlas Spine, Inc. The location of the test facility is not specified beyond the manufacturer's address in Jupiter, FL, USA. This is retrospective data collected for the purpose of a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the pre-clinical mechanical testing described. The "ground truth" here is compliance with engineering standards (ASTM F-2077 and ASTM F-2267), not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

Not applicable. This was mechanical testing against engineering standards.

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. This is a medical device (intervertebral body fusion device), not an AI diagnostic tool.

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

Not applicable. This is a medical device, not an AI algorithm.

7. The type of ground truth used:

For Mechanical Testing: Compliance with established engineering standards (ASTM F-2077 and ASTM F-2267) regarding mechanical properties and performance (e.g., load to failure, expulsion resistance, subsidence resistance, run-out load). The "ground truth" is adherence to these validated test methods and achieving results comparable to predicate devices.
For Substantial Equivalence: Comparison to the design, materials, indications for use, and mechanical function of previously cleared predicate devices (Novel® Spinal Spacer System, Atlas Spine Spacer, Pivotec Lumbar Interbody Fusion Device).

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for the type of testing described here.

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

Not applicable. There is no training set mentioned or implied.

Summary

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AUG 1 0 2010

1 1.1

510(k) SUMMARY

Manufacturer:Address:	Atlas Spine, Inc.1555 Jupiter Park Drive, Suite # 4Jupiter, FL 33458
Telephone:Fax:	561-741-1108561-741-1870
Official Correspondent:Title:	Jeannette G. DaileyVice President Regulatory Affairs &Quality Assurance
Telephone:	561-354-4319
Date Prepared:	June 4, 2010
Device Classification:	Intervertebral body fusion deviceClass II per 21 CFR §888.3080Product Code: MAX
Trade/Proprietary Name:	Atlas Spine Pivoting System
Common Names:	Intervertebral Body Fusion Device [IBFD]
Predicate Device:	Novel® Spinal Spacer SystemAlphatec Spinal, Inc.K080699
	Atlas Spine SpacerAtlas Spine, Inc.K091406
	Pivotec Lumbar Interbody Fusion DeviceCaptiva Spine, Inc.K092017

Device Description:

The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion.

The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an

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insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.

Intended Use:

Performance Data

Pre-clinical, mechanical testing was performed on the Atlas Spine Pivoting System. Testing consisted of static testing in a load to failure mode in axial compression; static testing in expulsion; static testing in subsidence; and dynamic axial compression testing to estimate the maximum run out load. Testing was performed in accordance with ASTM F-2077 and ASTM F-2267. Data have been submitted to characterize the performance of the Atlas Spine Pivoting System.

Discussion of the Technological Characteristics

The intended use, design, materials and functional characteristics of the Atlas Spine Pivoting System and the predicate devices are substantially the same. The height, width, length and lordotic angles of the Atlas Spine Pivoting implant are within the ranges available for the predicate devices. The Atlas Spine Pivoting implant and the predicate devices consist of a single piece that is made from implantable PEEK polymer. The Atlas Spine Pivoting implant, the Novel Spinal Spacer and the Pivotec implant are similarly "crescent" shaped. Each system is intended to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The Atlas Spine Pivoting implant and the predicate devices are placed within the area of removed or resected spine and are functionally complemented by supplemental fixation. Manipulation of the Atlas Spine Pivoting implant, the Novel Spinal Spacer and the Pivotec implant is achieved by a unique tool. The Atlas Spine Pivoting implant and the predicate devices are intended to be used with bone graft.

Conclusion

Provided documentation demonstrates that the Atlas Spine Pivoting System is substantially equivalent to the aforementioned predicate devices. This conclusion is g based on the devices' similarities in indications for use, design, function, materials and mechanical function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Public Health Service

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

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

AUG1 0 2010

Re: K100743

Trade/Device Name: Atlas Spine Pivoting System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 26, 2010 Received: July 27, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleding,

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 of edus in 1111111711 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 Ri gister.

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Page 2 - Ms. Jeannette G. Dailey

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Clarence Buekins

Mark N. Mel kerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

AUG 1 0 2010

Device Name: Atlas Spine Pivoting System

Indications for Use:

The Atlas Spine Pivoting System is indicated for spinial 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 at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.

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)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K100743 510(k) Number_

Page of of

(Posted November 13, 2003)

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.