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 TPS-TL Spinal System is indicated 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 collapsed 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 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 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 provided text describes modifications to an existing medical device, the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System, aiming for substantial equivalence to the previously cleared version (K010989). This document is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device rather than presenting a full de novo clinical study with acceptance criteria and detailed performance metrics as one might find for a novel device.

Therefore, the information you requested about acceptance criteria and a study proving the device meets them, particularly regarding AI/algorithm performance, is largely not present in this document because it pertains to a mechanical spinal implant, not an AI/algorithm-driven device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states that "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." However, it does not explicitly list the quantitative acceptance criteria for these functional requirements (e.g., specific load capacities, fatigue cycles, or displacement limits).

Reported Device Performance:
The document does not include reported device performance values against specific acceptance criteria. It only makes a general statement that the device "meets or exceeds" functional requirements based on "nonclinical tests."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the mechanical tests.
Data Provenance: The document states "nonclinical tests," implying laboratory mechanical testing, not human data. Therefore, country of origin or retrospective/prospective status are not applicable in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a mechanical implant; performance is assessed through engineering and materials testing, not through expert-established ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This device is a mechanical implant.

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 device is a mechanical implant and does not involve AI or human readers for its primary function or assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This document describes a physical medical device (spinal implant), not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a mechanical implant, the "ground truth" for performance is typically established by:

Engineering design specifications
Industry standards (e.g., ASTM F136 for materials, other ASTM standards for mechanical testing of spinal implants)
Performance of the predicate device.

The document refers to "functional requirements" and "mechanical testing," suggesting the ground truth for performance is based on these engineering and standards-based metrics.

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development or testing of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This document does not describe the development or testing of an algorithm or AI.

Summary regarding the provided text:

The provided 510(k) summary is for a physical spinal implant. It focuses on demonstrating substantial equivalence to a predicate device through:

Comparison of indications for use.
Comparison of materials (ASTM F136 Titanium alloy).
Comparison of basic design concept.
General statement of "mechanical testing" and "nonclinical tests" indicating the device "meets or exceeds all functional requirements."

It does not include the detailed performance metrics, acceptance criteria, or study design elements typically associated with the evaluation of AI/algorithm-driven medical devices, for which the requested information would be highly relevant.

Summary

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JAN 1 7 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

December 17, 2001

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:	Spinal Vertebral Body Replacement Device
Common/Usual Name:	Vertebral Body Replacement Device
Product Classification:	Class II
Proprietary Name:	Interpore Cross Telescopic Plate SpacerThoracolumbar (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

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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.

2014145

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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

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

Re: K014145

Trade Name: Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MQP Dated: December 17, 2001 Received: December 18, 2001

Dear Ms. Rodarti:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Lynn Rodarti

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough maing of substantial equivalence of your device to a legally premaired predicated 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 IT you desire specific ad roo for for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Fart 807.10 for his ville in the promotion and advertising of Compliance at (301) 594-1697 - 1657 - 165 - 1639 - 1639. Also, please note the your device, prodo of concerner a by reference to premarket notification" (21CFR Part 807.97). Tegulation ontined, Tribbranding on your responsibilities under the Act may be obtained from the Outcr general mistmation turers, 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,

R. Mark N. Mclellan

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

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KO14145 510(k) Number (if known):

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 Oross Telecoment devices intended for use in the Cystern inplante are columbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal ord treatment of tarnors in Crucific accessful height of a collapsed vertebral body. The and froural trough, and to receive cated for treating fractures of the thoracic and The TPS-TL Spinal System is designed to restore the lumbar spine. fumbal " spine." "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)

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Marlh N melkerson

Division of General, Restorative and Neurological Devices

510(k) Number K014145

A1-2

Regulation Number and Section

N/A