The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 GEO structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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 GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.

AI/ML Overview

The provided text is a 510(k) summary for the GEO™ Structure, a vertebral body replacement device. It mentions "nonclinical tests" and states that "Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use." However, it does not provide specific acceptance criteria or details of the study that proves the device meets those criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "Data regarding the functional performance... indicates that the proposed GEO Structure meets or exceeds all functional requirements," but it does not specify what those functional requirements (acceptance criteria) are, nor does it present the reported performance data in a quantifiable manner. For medical devices, acceptance criteria typically involve biomechanical tests (e.g., compression strength, fatigue life, torsional stability) compared against established standards or predicate device performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document refers to "nonclinical tests" but does not specify sample sizes or data provenance. "Nonclinical tests" usually refer to laboratory bench testing or in-vitro studies, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. This question is relevant for studies involving human interpretation (e.g., imaging studies). The provided document discusses nonclinical performance testing of a physical implant, not diagnostic interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. This is relevant for studies where expert consensus is needed. The document does not describe such a study.

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

Cannot be provided. This describes a clinical study design typically used for AI-powered diagnostic tools. The GEO™ Structure is a physical surgical implant, and the document discusses nonclinical testing of its functional performance, not AI diagnostic assistance.

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

Cannot be provided. This is relevant for AI algorithms. The GEO™ Structure is a physical surgical implant.

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

Cannot be provided. For nonclinical tests of a physical device, ground truth would typically be derived from engineering specifications, material properties, and established biomechanical standards, as opposed to medical diagnoses or patient outcomes. The document does not specify these.

8. The sample size for the training set

Cannot be provided. "Training set" is relevant for machine learning/AI. This document describes a physical medical device and its nonclinical testing.

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

Cannot be provided. Similar to point 8, this is not applicable to the type of device and testing described.

Summary

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510(k) SUMMARY

K020048

SUBMITTED BY

2/6/02

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

(949) 453-3200

January 4, 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: GEOTM Structure

PREDICATE DEVICE

The predicate device is the GEO™ Structure (K010530).

INDICATIONS-FOR-USE

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 GEO structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, with wavy lines below them. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the design, with "SERVICES" at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ms. Lynn M. Rodarti Manager, Clinical and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K020048

Trade/Device Name: GEO™ Structure Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 4, 2002 Received: January 7, 2001

Dear Ms. Rodarti:

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.

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Page 2 - Ms. Lynn Rodarti

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

R. Martin 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

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K 02 0048

Page 1 of 1

510(k) Number (if known):

GEO Structure Device Name:

Indications-For-Use:

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) 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 le admore a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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 A Millican

Division Sign-Off) (Division Sigi-Ori)
Division of General, Resions Divisiourological Devices 1620048

510(k) Number .

Prescription Use (PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-

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.