The PEEK CAS 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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

The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. 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 additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

AI/ML Overview

This 510(k) submission (K050861) for the PEEK CAS device does not include a study describing acceptance criteria, device performance, or ground truth establishment based on clinical data or expert evaluations.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices (Interpore Cross Expandable PEEK VBR (K040928) and Interpore Cross NEXUS (K040168)) through:

Same indications for use: The device targets the same clinical conditions and anatomical region as the predicates.
Intended use: The purpose of the device (partial vertebral body replacement) aligns with the predicates.
Similarity in materials of construction: It uses PEEK OPTIMA™ LT1, a medical-grade material, also used in similar devices.
Equivalent biomechanical performance: This typically implies that the device has undergone non-clinical (e.g., in-vitro mechanical) testing to demonstrate its structural integrity and mechanical properties are comparable to the predicate devices and suitable for its intended use. However, the specific details or results of such tests (acceptance criteria, performance data) are not provided in this summary.

Therefore, I cannot populate the table or answer most of your specific questions as the provided text does not contain that information.

Here's what can be inferred or explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text.	Not specified in the provided text, beyond "equivalent biomechanical performance" to predicate devices.

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

Not applicable / Not provided: The document describes a substantial equivalence submission based on device characteristics and intended use, not a clinical study with a "test set" of patient data.

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

Not applicable / Not provided: No clinical ground truth establishment is described.

4. Adjudication method for the test set

Not applicable / Not provided: No clinical test set or adjudication process is described.

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: This is a medical device for vertebral body replacement, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

No: This is a physical implant, not an algorithm or software device.

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

Not applicable / Not provided in the context of clinical performance evaluation: The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior approval and marketing. The PEEK CAS aims to meet this "ground truth" through equivalence in design, materials, and biomechanical performance.

8. The sample size for the training set

Not applicable / Not provided: No computational model or AI training is described.

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

Not applicable / Not provided: No computational model or AI training is described.

Summary of Device and Submission Type:

This 510(k) submission for the PEEK CAS is for a physical implantable medical device used for vertebral body replacement. The primary method for gaining market clearance is by demonstrating substantial equivalence to already approved predicate devices, rather than conducting new clinical trials that would involve the kind of performance data, acceptance criteria, and ground truth establishment you are asking about. The "study" mentioned would primarily consist of engineering and materials testing to show equivalent biomechanical performance.

Summary

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510(k) SUMMARY

K050861 Page I of I

SUBMITTED BY

Wendy Spielberger, RAC Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200

Date Prepared: April 4, 2005

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Common/Usual Name: Product Classification: Product Code: Proprietary Name:

Spinal Intervertebral Fixation Orthosis Vertebral Body Replacement Device Class II MOP PEEK CAS

PREDICATE DEVICE

Interpore Cross Expandable PEEK VBR (K040928) Interpore Cross NEXUS (K040168)

INDICATIONS-FOR-USE

The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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

COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the PEEK CAS is considered substantially equivalent to the legally marketed predicate device.

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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 lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

Ms. Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K050861

Trade/Device Name: PEEK (CAS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 5, 2005 Received: May 6, 2005

Dear Ms. Spielberger:

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 (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. Wendy Spielberger

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" (21 CFR 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,

A. Hyat Clurdie

C. Provost, Ph.D. Acting 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): K050861

Device Name: PEEK CAS

Indications-For-Use:

The PEEK CAS 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stypt. Burch

Page 1 of 1

(Division Division of General, Restorative. and Neurological Devices

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.