The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace 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 Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System 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.

Device Description

Not Found

AI/ML Overview

The provided text describes a medical device, the Solitaire™ Anterior Spinal System, and its regulatory submission. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested by the prompt (i.e., performance metrics, sample sizes, expert involvement, etc.).

Instead, it's a 510(k) premarket notification for a spinal system, which is primarily focused on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and mechanical performance. The "Performance Testing" section states that "Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance." It then adds, "The design requirements were established based on those of the previously cleared predicate devices."

This indicates that the study involved mechanical testing, but the details of that testing, including specific acceptance criteria, reported performance, sample sizes, or any human-in-the-loop aspects, are not present in this document.

Therefore, I cannot populate the table and answer the specific questions as requested, as the necessary information is not available in the provided text.

Summary of missing information:

No specific acceptance criteria metrics are listed.
No reported device performance values are given.
No sample sizes for test sets or training sets are mentioned.
No data provenance details are provided.
No information on experts (number, qualifications, adjudication) is present, as this was a mechanical test, not an image-based or diagnostic study.
No MRMC comparative effectiveness study or standalone algorithm performance is discussed, as this is a physical medical device, not an AI/software device.
No details on ground truth establishment are available.

Summary

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K062-810 1/2

EBI, L.P./Biomet Spine

Solitaire" Anterior Spinal System

OCT 1 7 2006

SUBMITTER:	EBI, L.P.
ADDRESS:	100 Interpace ParkwayParsippany, NJ 07054
PHONE:	(973) 299-9300
FAX:	(973) 257-0232
CONTACT PERSON:	Debra L. BingDirector, Regulatory Affairs
SUBMISSION PREPARED BY:	Jennifer P. Harakal
DATE PREPARED:	September 8, 2006
TRADE NAME:	Solitaire™ Anterior Spinal System
COMMON NAME:	Vertebral Body Replacement
CLASSIFICATION NAME:	Vertebral Body Replacement
PREDICATE DEVICE:	-Interpore Cross International Anterior Fixation Device(AFD)-Interpore Cross International Expandable PEEK VBRSystem-EBI ESL Spine Spacer System

INTENDED/INDICATIONS FOR USE:

The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace 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 Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System 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.

TECHNOLOGICAL CHARACTERISTICS:

Performance Testing

Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance. The design requirements were established based on those of the previously cleared predicate devices.

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Substantial Equivalence

The Solitaire Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and basic principles of operation. This premarket notification is being submitted to address a design modification, as well operation. This premarker notification is being system. As demonstrated by performance data, as to renect additional components to assess any hew issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, LP % Ms. Debra Bing Director, Regulatory Affairs 100 Interpace parkway Parsippany, New Jersey 07054

OCT 1 7 2006

Re: K062810

Trade/Device Name: Solitaire™ Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Fixation Device Regulatory Class: Class II Product Code: MQP Dated: September 15, 2006 Received: September 19, 2006

Dear Ms Bing:

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, and 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. Debra Bing

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 yours,

Barbara Buchm

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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11 Indications for Use Statement

510(k) Number (if known):

Device Name: Solitaire™ Anterior Spinal System i

Indications for Use:

The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., TIA to L.S) to replace a diseased vertebral body resected or excised for the treament of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the thoracis achieve anterior decompression of the Spinar core tax indicated for treating fractures of the thoracity of the collapsed vertebral body. The Sollaire System is designed to restore the biomechanical integrity of the and lumbar spine. The Soltane System is dosigned to reneve of fusion for a prolonged period.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

K06.2810(koubaue Pueeuno

(Division Sign-Of Division of General. Restorative, and Neurological Devices

510(k) Number K062810

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.