The Interpore Cross International AFD 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 Interpore Cross International AFD is also indicated for treating fractures of the thoracic and lumbar spine. The Interpore Cross International AFD 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 Interpore Cross International AFD is a titanium alloy spacer for vertebral body replacement. It has a predominately hollow center and outer ring with screws for fixation into the vertebral bodies. The hollow center allows for the addition of bone graft material. In addition, there are ridges on the superior and inferior surfaces of the implant to enhance placement and prevent expulsion.

AI/ML Overview

The provided text describes a 510(k) summary for the Interpore Cross International Anterior Fixation Device (AFD). This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text, addressing your specific points:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Functional Requirements (various mechanical tests)	"Mechanical testing, including static axial compression, torsional loading, shear compression and expulsion testing indicates that the proposed Interpore Cross International AFD meets or exceeds all functional requirements and supports its suitability for use."
Material Safety and Biocompatibility	Implied to be acceptable as "the use of established well known materials" is mentioned in comparison to the predicate device.
Biomechanical Integrity Restoration	"The Interpore Cross International AFD 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." This is a stated design goal that the mechanical testing is presumed to support.

Missing Information: The specific numerical targets for each mechanical test (e.g., minimum compression strength in Newtons) and the actual numerical results achieved by the AFD are not detailed in this summary. The summary only gives a qualitative statement that the device "meets or exceeds all functional requirements."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical testing. "Data regarding the functional performance... has been generated" implies a test set was used, but the quantity of devices tested for each mechanical assessment is not mentioned.
- Data Provenance: The study is non-clinical mechanical testing, performed by Interpore Cross International. No information is given regarding country of origin of data or whether it's retrospective/prospective, as these terms are typically applied to human clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical mechanical engineering study, not involving human experts for ground truth establishment in the way clinical studies do. The "ground truth" is defined by established engineering and biomechanical standards for spinal implants.
Adjudication method for the test set:
- Not applicable. This was mechanical testing, not requiring adjudication by human experts.
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 for vertebral body replacement, not an AI-assisted diagnostic or imaging device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone mechanical testing was done (the device itself was tested). However, "standalone" in this context typically refers to an algorithm's performance without human interaction, which is not relevant for this physical implant.
The type of ground truth used:
- The ground truth for the mechanical testing was based on "all functional requirements," which are derived from established engineering standards and biomechanical principles for spinal implants. These would typically include industry standards and possibly internal company specifications for static axial compression, torsional loading, shear compression, and expulsion.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an algorithm that requires a "training set" in the machine learning sense. The design and manufacturing process would involve iterative testing and refinement, but this isn't a "training set" like in AI.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7. The "ground truth" for the performance specifications of the device would be based on biomechanical considerations and regulatory requirements, influencing the device's design and engineering.

Summary

{0}------------------------------------------------

022143
page 1 of 2

510(k) SUMMARY

SUBMITTED BY

Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

JAN 2 3 2003

(949) 453-3200

July 1, 2002

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Vertebral Body Replacement Common/Usual Name: Vertebral Body Replacement Product Classification: Class II Proprietary Name: Interpore Cross International Anterior Fixation Device (AFD)

PREDICATE DEVICE

The predicate device is the GEO™ Structure that is currently manufactured and distributed by Interpore Cross International.

INDICATIONS-FOR-USE

DEVICE DESCRIPTION

{1}------------------------------------------------

COMPARISON TO THE PREDICATE DEVICE

The Internore Cross International AFD is substantially equivalent to the GEO Structure that is currently manufactured and distributed by Interpore Cross International. Both implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and have equivalent potential for complications for the risk of use. In addition, they both represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. Based on the basic design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis, Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to the existing legally marketed device.

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed Interpore Cross International AFD has been generated. Mechanical testing, including static axial compression, torsional loading, shear compression and expulsion testing indicates that the proposed Interpore Cross International AFD meets or exceeds all functional requirements and supports its suitability for use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, with three wave-like lines above them.

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wendy Spielberger Senior Clinical Regulatory Coordinator Interpore Cross International 181 Technology Drive Irvine, CA 92618-2402

Re: K022143

Trade/Device Name: Interpore Cross International Anterior Fixation Device Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: Class II Product Code: MQP Dated: November 20, 2002 Received: November 21, 2002

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.

{3}------------------------------------------------

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 (301) 594-4659. 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 may be obtained 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 N Milken

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

{4}------------------------------------------------

510(k) Number (if known): K022143

Device Name: Interpore Cross International Anterior Fixation Device (AFD)

Indications-For-Use:

The Internore Cross International AFD 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 Interpore Cross International AFD is also indicated for treating fractures of the thoracic and lumbar spine. The Interpore Cross International AFD 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milken

ivision Sign-Off) Division of General. Restorative and Neurological Devices

KO22145 · 10(k) Number_

Prescription Use (PER 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.