The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial 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 EBI CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI Spinal System, or the EBI Array Spinal System.

Device Description

The CAS Spine Spacer System is design modification of the EBI ESL Spine Spacer System. The EBI CAS Spine System is a vertebral body replacement device consisting of one curved implant. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for more bone growth through the device. The EBI CAS Spine Spacer System is intended for use with the EBI NGC Spinal System, the EBI Omega21™ Spinal System, EBI SpineLink™ II Spinal System, or the EBI Array Spinal System as a supplemental internal fixation system.

AI/ML Overview

The provided 510(k) summary for the EBI CAS Spine Spacer System does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, materials, and function.

The key points from the document regarding performance are:

Mechanical testing: "Mechanical testing comparing the EBI ESL Spine Spacer System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements."

Without specific details on the "applicable standards and guidelines," the "functional requirements," or the results of the "mechanical testing," it's impossible to create the requested table of acceptance criteria and reported device performance.

Therefore, many of the requested sections (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type, training set details) cannot be answered from the provided text.

Based on the available information, here is what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The general criteria would be compliance with applicable standards and functional requirements for spinal fixation devices.	Demonstrated compliance with "applicable standards and guidelines and meets all of its functional requirements" through mechanical testing when compared to a predicate device (EBI ESL Spine Spacer System).

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

Sample size: Not specified. The document mentions "mechanical testing" but does not detail the number of units or any other sample size for this testing.
Data provenance: Not specified, but given it's mechanical testing of a medical device, it would be laboratory-based testing rather than clinical data from a specific country or patient population. It is a retrospective comparison to a predicate device's performance.

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

Not applicable as this was mechanical testing, not a study requiring expert readers to establish ground truth for image interpretation or clinical outcomes.

4. Adjudication method for the test set

Not applicable as this was mechanical testing, not a study requiring adjudication of expert readings.

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

No MRMC comparative effectiveness study was done. This 510(k) pertains to a physical medical implant (spinal spacer), not an AI-powered diagnostic or assistive technology.

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

Not applicable, as this is a physical medical implant and not an algorithm or AI system.

7. The type of ground truth used

For mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and performance standards for spinal implants (e.g., strength, fatigue resistance, stability) as defined by regulatory bodies and relevant ASTM standards. These were presumably used in the "applicable standards and guidelines."

8. The sample size for the training set

Not applicable, as this is a physical medical implant, not an AI system that requires a training set.

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

Not applicable, as this is a physical medical implant.

Summary

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1042268

OCT 2 7 2004

510(k) Summary

This 510(k) Summary for the EBI AIS System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

1. Submitter: Frederic Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
  Contact Person: Frederic Testa, RAC Telephone: 973-299-9300 Fax: 973-257-0232

Date prepared: August 13, 2004

2. Proprietary Name:	EBI CAS Spine Spacer System
Common Name:	Spinal Fixation Device
Classification Name/Code:	Spinal Vertebral Body Replacement Device/MQP

3. Predicate or legally marketed devices that are substantially equivalent:

· EBI ESL Spine Spacer System (K040482)
· EBI Ionic Spine Spacer System (K020887)
1. Description of the device: The CAS Spine Spacer System is design modification of the EBI ESL Spine Spacer System. The EBI CAS Spine System is a vertebral body replacement device consisting of one curved implant. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for more bone growth through the device. The EBI CAS Spine Spacer System is intended for use with the EBI NGC Spinal System, the EBI Omega21™ Spinal System, EBI SpineLink™ II Spinal System, or the EBI Array Spinal System as a supplemental internal fixation system.
1. Intended Use: The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial 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 EBI CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI Spinal System, or the EBI Array Spinal System.
1. Materials: The CAS Spine Spacer System is manufactured from Titanium, Ti-6Al-4V ELI, per ASTM F136.

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1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI CAS Spine Spacer System and other currently marketed spine systems. The EBI CAS Spine Spacer System is substantially equivalent* to the predicate devices in regards to intended use, materials and function. Mechanical testing comparing the EBI ESL Spine Spacer System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements.

Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

MAN SERVICE

Public Health Service

OCT 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K042268

Trade/Device Name: EBI CAS Spine Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: September 28, 2004 Received: September 29, 2004

Dear Mr. Testa:

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 for abound in 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 - Mr. Frederick Testa, RAC

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K0402268

Device Name: EBI CAS Spine Spacer System

Indications For Use:

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., The LDI CAS Spille Dpacer Bystem partial vertebrectomy) of a diseased vertebral body 11- L.) 101 partial replacement (10), for promote to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral of the spinar cord and nearly asser System is also indicated for treating fractures of the body. The EDI CHO Upme Spacer System Spacer System is designed to restore the thoracic and fulliour spine. "The anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. The system must be used in absence of railer for a pNGC Spinal System, EBI Omega 21 Spinal System, EBI SpineLink II Spinal System, or the EBI Array Spinal System.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mullison

Division of General, Restorative, and Neurological Devices

K042268
510(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.