The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).

The CPOD/LPOD 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. middle alle posterior upmar over and to be packed into the interior openings of the device prior to implantation.

The CPOD/LPOD is intended to be used with supplemental, internal spinal fixation The Cr OD/El OD is intended to or arm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

Device Description

The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Theken Surgical CPOD / LPOD Vertebral Body Replacement System (CPOD / LPOD VBR)". This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based device evaluations.

Therefore, many of the requested categories for a study proving acceptance criteria (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context, as this is a regulatory submission for a physical medical implant, not an AI/algorithm-based diagnostic or screening tool.

However, I can extract information related to the device's characteristics and the basis for its approval.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance metrics like one would find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is therefore implicitly "equivalent" to that of the predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Implied by Substantial Equivalence)
Intended Use Equivalence	The Theken CPOD / LPOD VBR has essentially the same indications for use as the predicate devices (Tetris™ Spinal Implant, Stackable Cage™ System, Synthes Synex™ System).
Design and Physical Characteristics Equivalence	The device is similar in design, material composition (Titanium Ti-6Al-4V), and construction to the predicate devices. It uses frames with fenestrations and toothed spikes, combined with spacer components, to create an implantable construct.
Material Composition Equivalence	Made of Titanium Ti-6Al-4V (ELI) per ASTM F-136, which is a standard biomaterial also used in similar predicate devices.
Biomechanical Integrity Restoration	Designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, similar to the function of predicate VBR systems.
Compatibility with Supplemental Fixation	Intended to be used with supplemental internal spinal fixation systems as are comparable predicate devices.
Safety and Effectiveness	Believed to have equivalent potential for complications and to be safe and effective based on design, materials, feature comparisons, and mechanical testing, similar to predicate devices.

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

Not Applicable. This is a 510(k) for a physical implant, not a study involving a "test set" of patient data for performance evaluation in the typical sense. Equivalence is established through comparison of design, materials, intended use, and mechanical testing on the device itself.

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

Not Applicable. See point 2. The "ground truth" here relates to engineering principles, material science, and clinical practice for spinal implants. Regulatory bodies (FDA) and potentially design engineers at Theken Surgical/consultants would be the "experts" in this context, evaluating compliance with standards and equivalence.

4. Adjudication Method:

Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not a diagnostic device or an AI assistant for human readers. Therefore, an MRMC study is not relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptability is based on:
- Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR 878.3060 for Vertebral Body Replacement Devices).
- Material Standards: Use of ASTM F-136 compliant Titanium Ti-6Al-4V (ELI).
- Biomechanical Engineering Principles: The design's ability to restore biomechanical integrity.
- Clinical Precedent: The established safety and effectiveness of the predicate devices.
- Mechanical Testing: Though not detailed in the provided text, the document mentions "mechanical testing" as a basis for equivalence. This typically involves in-vitro biomechanical tests simulating physiological loads on the implant.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. This is not an AI/machine learning model.

Summary

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Theken Surgical

CPOD / LPOD VBR System (K032064)

FEB 2,0 2004

510(k) Summary

(21 CFR Part 807.92)

A. Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Contact Person: Date Prepared:

B. Device Information

Trade Name:

Common Name: Classification Name: Device Classification:

Predicate Device: Comparative Device:

Material Composition: Subject Device Description:

Intended Use:

Theken Surgical 283 E. Waterloo Akron, Ohio 44319 330-773-7677 x221 330-773-7697 Tony Perry 12/12/2003

Theken CPOD / LPOD Vertebral Body Replacement System (CPOD / LPOD VBR) Vertebral Body Replacement Device Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 878.3060) Class II (per 21 CFR 878.3060) Panel: Orthopedic, Product Code: MQP, Panel Code: 87 SIGNUS Medical LLC Tetris™ Spinal Implant (K022793) DePuy AcroMed, Inc. Stackable Cage TM System (K990148) Synthes Spine Company, L.P. Synthes SynexTM Spacer System (K003836) Osteotech Inc., VBRTM (K003155) Titanium Ti-6Al-4V (ELI) per ASTM F-136. The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken CPOD / LPOD VBR is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).

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"7- 2

C. Substantial Equivalence

The technological characteristics of the Theken CPOD / LPOD VBR are similar to the following predicate devices:

1. Tetris™ Spinal Implant (K022793), manufactured by SIGNUS Medical LLC and cleared by the FDA on April 8, 2003.
Stackable Cage™ System (K990148), manufactured by DePuy AcroMed, Inc. and cleared by the FDA 2) on September 3, 1999.
1. Synthes Synext System (K003836), manufactured by Synthes Spine Company, L.P. and cleared by the FDA on May 29, 2001.

Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contradictions for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis (adherence to GLP), Theken Surgical believes that sufficient evidence exists to reasonably conclude that the CPOD / LPOD VBR is substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest feathers and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Mr. Tony Perry Theken Surgical 283 East Waterloo Road Akron, Ohio 44319

Re: K032064 Trade Name: Theken Surgical CPOD and LPOD Vertebral Body Replacement Devices Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Device Regulatory Class: II Product Code: MQP Dated: December 2, 2003 Received: December 9, 2003

Dear Mr. Perry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your occurent in the pequivalent (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 approvisions of the Act. The Act. The general controls provisions of the Act include the general on pro recistration, 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 1 car suiteres and regulation, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Act 3 requirements modellage practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Tony Perry

This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally made to the market notification. The I DA Initing of substantial equive 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 the Office of Comphance at (301) 59 + 1657 Part 807.97). You may obtain other general information on reference to promative the Act from the Division of Small Manufacturers, International and your responsibilities under the rion ber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mule M. Mullerson

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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Indications for Use

510(k) Number (if known):

K032064

Device Name:

Theken Surgical CPOD/LPOD VBR

Indications For Use:

The CPOD/LPOD is indicated for use in the thoracolumbar spine (i.c. T1 to L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (e.g. fracture).

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

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)

fo Mark N. Millenson

Division of General. Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K032064

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.