The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.

Device Description

The StaXxTM XD System is a vertebral body replacement device composed of wafers that are stacked into an expandable implant to adjust its height. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate. The system also includes a delivery device to implant and expand the system. The device is offered in sizes ranging from 7mm to 30mm.

AI/ML Overview

This document is a 510(k) summary for the StaXx™ XD System, a vertebral body replacement device. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and a comparison of intended use, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable or cannot be extracted from this document.

However, I can provide the available information:

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

Based on the document, the primary "acceptance criterion" presented implicitly is the device's ability to meet "performance requirements for its intended use" through mechanical testing, demonstrating its substantial equivalence to predicate devices. Specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed in this 510(k) summary, as it's for a hardware medical device rather than an AI/software device.

Acceptance Criterion (Implicit)	Reported Device Performance
Meets performance requirements for intended use.	"Mechanical testing demonstrated that the StaXx™ XD System meets the performance requirements for its intended use" and that "the StaXx™ XD System and the predicate devices do not affect the safety or effectiveness of this device." (Page 2)
Substantial equivalence to predicate devices based on design and intended use.	The StaXx™ XD System was demonstrated to be substantially equivalent to the VERTE-STACKTM Spinal System, the Blackstone™ PEEK VBR System, the PEEK Tetris™ System, the Sustain Radiolucent Spacer, and The Wafer System. (Page 1)

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

The document does not describe a clinical "test set" in the context of diagnostic performance or AI model evaluation. The "testing" mentioned is mechanical testing. Therefore, sample size and data provenance in this context are not applicable.

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

Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on clinical diagnoses) is not relevant to this 510(k) summary for a hardware implant.

4. Adjudication method for the test set

Not applicable. There is no clinical test set described that would require an adjudication method.

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 document describes a medical device (spinal implant), not an AI-assisted diagnostic tool.

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

Not applicable. This document is not about an algorithm or software. It describes a physical spinal implant.

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

For the mechanical testing mentioned, the "ground truth" would implicitly be relevant engineering standards and biomechanical properties required for spinal implants. This is not explicitly detailed in the document beyond stating that the device "meets the performance requirements."

8. The sample size for the training set

Not applicable. There is no AI model or "training set" described in this document.

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

Not applicable. There is no AI model or "training set" described in this document.

Summary

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510(k) Summary StaXx™ XD System

APR 2 7 2006

I. Submitter Information

Spine Wave, Inc.
Two Enterprise Drive
Suite 302
Shelton, CT 06484

Telephone:	203-944-9494
Telefax:	203-944-9493

Contact:	Ronald K. Smith
Date Prepared:	March 5, 2006

II. Device Information

Trade name:	StaXx™ XD System
Common name:	Vertebral Body Replacement
Classification:	Class II per 21 CFR 888.3060
Classification Name:	Spinal Intervertebral Fixation Orthosis
Product Code:	MQP

III. Device Information

IV. Intended Use

V. Substantial equivalence

The StaXx™ XD System was demonstrated to be substantially equivalent to the VERTE-STACKTM Spinal System (Medtronic Sofamor Danek, K043566), the Blackstone™ PEEK VBR System (Blackstone Medical, Inc., K041939 and K033702), the PEEK Tetris™ System (SIGNUS Medical LLC, K031757), the Sustain Radiolucent Spacer (Globus Medical Inc., K040284) and The Wafer System (Spine Wave, K033303). In addition, mechanical testing demonstrated

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KC52670
Page 2 of 2

that the StaXx™ XD System meets the performance requirements for its intended that the BlaAx - AD bystem moos any M XD System and the predicate devices do not affect the safety or effectiveness of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR . 7 2006

Spine Wave, Inc. c/o Mr. Ronald K. Smith Director, Quality and Regulatory Affairs Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484

Re: K052670

Trade/Device Name: StaXxTM XD System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP Dated: January 26, 2006 Received: January 27, 2006

Dear Mr. Smith:

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

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Page 2 - Mr. Ronald K. Smith

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), please contact the Office of Compliance at (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours,

Marli A. Milhiss

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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A. Indications for Use

510(k) Number (if known):

StaXx™ XD System Device Name:

Indications for Use:

The StaXx™ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with bone graft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXxTM XD System is the Stryker Xia® Spinal System.

r Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

Allala Mckeen
(Print Name of Officer)

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

510(k) Number K0526

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.