The TPS-TL Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (i.e., T3 to L5). The Intended for accommissindicated to replace a diseased vertebral body(ies) 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 collansed vertebral body(ies). The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The TPS-TL Spinal System is treating trestore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Device Description

The TPS-TL Spinal System implants function as a single construct that combines an anterior plate and a vertebral body spacer which may be telescopically adjusted in situ to the required height. The TPS-TL Spinal System implants are composed of seven components: one (1) female chamber, one (1) male chamber, one (1) set screw, and four (4) bone screws. The TPS-TL Spinal System implants are made from medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI) and are available for one and two levels.

AI/ML Overview

The deferral for this device, K020204, is for the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System. This is a spinal vertebral body replacement device, not an AI/ML powered device. Due to the nature of the device being a physical implant rather than a software algorithm, many of the requested categories related to AI/ML device studies (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable in this context.

Here's the information that can be extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify explicit numerical "acceptance criteria" in the way a performance study for an AI/ML device would. For a medical implant like the TPS-TL Spinal System, acceptance criteria are typically met by demonstrating substantial equivalence to a predicate device through materials, design, indications for use, and mechanical testing. The "reported device performance" refers to the successful completion of these tests.

Acceptance Criteria Category	Reported Device Performance
Functional Requirements	Met or Exceeded: "The test data indicates that the proposed Interpore Cross TPS-TL Spinal System meets or exceeds all functional requirements and support its suitability for use." This implies the device performs its intended mechanical functions (e.g., support, adjustability) adequately.
Biomechanical Integrity Restoration	Demonstrated: Indicated "to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period." While not a direct performance measurement in this section, the device's design and mechanical testing are intended to support this claim.
Substantial Equivalence to Predicate	Achieved: "sufficient evidence exists to reasonably conclude that this device is substantially equivalent to the existing legally marketed implants." This is the overarching acceptance criterion for 510(k) clearance, based on comparisons in design, materials, indications for use, and mechanical testing. The predicate device is the "Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System which was previously cleared under 510(k) K010989." This means the new device's performance aligns with the safety and effectiveness established for the predicate device.
Material Composition	Compliant: Composed of "medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI)." This meets material standards for medical implants.
Indications for Use (IFU)	Consistent: The device treats "the same conditions, have the same precautions and contraindications for use" as the predicate device.
Potential for Complications	Equivalent: Has "equivalent potential for complications associated with the risk of use" compared to the predicate device.
Basic Design Concept (Safety & Effectiveness)	Equivalent: "they both represent a basic design concept in terms of safety and effectiveness."

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

Sample size: Not applicable in the context of an AI/ML test set. The study refers to "test data," but this would be mechanical engineering tests on physical devices (e.g., fatigue testing, compression strength testing), not a dataset of patient information.
Data provenance: Not applicable. The "data" refers to the results of nonclinical mechanical tests, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable: Ground truth in this context would be engineering specifications and validated test methods for mechanical performance. There is no mention of "experts" establishing a clinical "ground truth" for a test set as would be done for an AI/ML device. The "experts" involved would be the engineers designing and testing the device, and those reviewing the results against established standards.

4. Adjudication method for the test set

Not applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among human readers in interpreting clinical data for AI/ML performance studies. This is not relevant for a mechanical device.

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

Not applicable: This is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable: This device is a physical implant and does not involve an algorithm.

7. The type of ground truth used

Not applicable/Implied: For a medical device like this, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136), and validated biomechanical test methods that define acceptable performance and safety. The goal is to demonstrate the device meets these pre-defined physical and mechanical requirements.

8. The sample size for the training set

Not applicable: This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable: As there is no training set for this type of device, ground truth establishment for a training set is not relevant.

Summary

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K020204 p 1/2

FEB 2 1 2002

510(k) SUMMARY

SUBMITTED BY

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

(949) 453-3200

January 21, 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

Spinal Vertebral Body Replacement Device Classification Name: Vertebral Body Replacement Device Common/Usual Name: Class II Product Classification: Interpore Cross Telescopic Plate Spacer Thoracolumbar Proprietary Name: (TPS-TL™) Spinal System

PREDICATE DEVICE

The predicate device is the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System which was previously cleared under 510(k) K010989.

INDICATIONS-FOR-USE

DEVICE DESCRIPTION

The TPS-TL Spinal System implants function as a single construct that combines an anterior plate and a vertebral body spacer which may be telescopically adjusted in

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situ to the required height. The TPS-TL Spinal System implants are composed of seven components: one (1) female chamber, one (1) male chamber, one (1) set screw, and four (4) bone screws. The TPS-TL Spinal System implants are made from medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI) and are available for one and two levels.

COMPARISON TO THE PREDICATE DEVICE

The larger Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System implant is substantially equivalent to the currently available TPS-TL Spinal System implants. All implants are used to treat the same conditions, have the same precautions and contraindications for use, and have equivalent potential for complications associated with the risk of use. In addition, they both represent a basic design concept in terms of safety and effectiveness.

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 implants.

DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System have been generated. The test data indicates that the proposed Interpore Cross TPS-TL Spinal System meets or exceeds all functional requirements and support its suitability for use.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2002

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

Re: K020204

Trade/Device Name: Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 21, 2002 Received: January 22, 2002

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 yours,

Mark N 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

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510(k) Number (if known): KO2O204

Telescopic Plate Spacer Thoracolumbar (TPS-TL) Device Name: Spinal System

Indications-For-Use:

The Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal The Interpore order order replacement devices intended for use in the Oronia information thoracolumbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the indivated to replace a achieve anterior decompression of the spinal cord treatment of tamore in o to restore the height of a collapsed vertebral body. The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and The TPS-TL Spinal System is designed to restore the lumbar spine. lumbur - opino: - The anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Mark n Milken

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

510(k) Number_

KO₂0204

Regulation Number and Section

N/A