The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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

This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.

AI/ML Overview

This 510(k) summary focuses on the EBI® ESL® PEEK-OPTIMA® Spine System, a vertebral body replacement device. The document states that the primary purpose of this submission is to add PEEK spacers to an existing system and demonstrate substantial equivalence to predicate devices through mechanical testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria or detailed results of device performance in a table format. It broadly mentions "Mechanical testing demonstrated comparable mechanical properties to the predicate components."

Therefore, a table cannot be constructed from the given text.
Sample size used for the test set and the data provenance:

The document mentions "Mechanical testing," but does not specify the sample size used for these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study described is mechanical testing of a medical device, not a study involving human interpretation of data where "ground truth" would be established by experts.
Adjudication method for the test set:

This information is not applicable as the study described is mechanical testing, not a study requiring adjudication of expert opinions.
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 applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI systems where human interpretation is involved. This submission is for a spinal implant, and the supporting data is mechanical testing, not a clinical study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This device is a physical implant, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable in the context of mechanical testing. The "ground truth" for mechanical testing would be established by engineering standards and validated testing methodologies, not by expert consensus, pathology, or outcomes data in the traditional sense. The standard for evaluation is "comparable mechanical properties to the predicate components."
The sample size for the training set:

This information is not applicable. There is no mention of a "training set" in the context of the mechanical testing conducted for this device. Training sets are relevant for AI algorithms.
How the ground truth for the training set was established:

This information is not applicable for the same reasons as point 8.

Summary

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K061016

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510(k) Summary EBI® ESL® PEEK-OPTIMA® Spine System

JUN - 8 2006

Proprietary Name:	ESL® PEEK-OPTIMA® Spine System
Common Name:	Vertebral Body Replacement Device
Classification Name:	Spinal Intervertebral Fixation Orthosis, 21CFR §888.3030
Product Code:	MQP
Predicate Device(s):	EBI® ESL® Spine Spacer SystemInterpore Cross International PEEK CAS
Contact Information:	Jennifer Harakal, Regulatory Affairs SpecialistEBI, L.P.100 Interpace ParkwayParsippany, NJ 07054Phone: 973-299-9300 x2156
Date Summary Prepared:	May 15, 2006

Indications for Use

The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L.5) for partial replacement 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 ESL® PEEK Spine Spacer System is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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

This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.

Substantial Equivalence

The subject ESL PEEK-OPTIMA Spine System is similar to its predicate devices with respect to intended use and basic design. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

EBI, LP % Ms. Jennifer P. Harakal Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K061016

Trade/Device Name: EBI® ESL® PEEK-OPTIMA® Spine System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 17, 2006 Received: May 18, 2006

Dear Ms. Harakal:

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 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 - Ms. Jennifer P. Harakal

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/industry/support/index.html.

Sincerely yours,

Hucker Lemar no

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): ﮪ / ○ / ﻁ / ○ / ﻁ / ○ / ﻁ / ○ / ﻁ / ﻁ / ○ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ /

Device Name: EBI® ESL® PEEK-OPTIMA® Spine System

Indications For Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D AND/OR

Over-The-Counter

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Huber Romer

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

510(k) Number K061016

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.