The StaXx® XDL 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 used with autograft or allograft and supplemental spinal fixation.

Device Description

The StaXx® XDL System is composed of wafers that are stacked into an expandable implant to adjust the height of the implant. The implant components are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain tantalum markers for additional visualization under fluoroscopy. The system also includes a delivery device to place and expand the system.

AI/ML Overview

The StaXx® XDL System is a vertebral body replacement device. The provided text indicates that the device's acceptance was based on non-clinical performance testing demonstrating substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of measured performance against a pre-defined threshold. The device is 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).

Here's a breakdown of the information based on the provided text, addressing the points where possible:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" for the StaXx® XDL System or report specific numerical performance outcomes against such criteria. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject StaXx® XDL System is substantially equivalent to the listed predicate devices." The performance evaluation was qualitative in nature, aiming to show similarity to existing approved devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Achieved through testing)
Substantial equivalence to predicate devices for mechanical properties	Demonstrated equivalence through non-clinical testing to ASTM F2077 and ASTM F2267.
Performance in static axial compression	Testing performed.
Performance in dynamic axial compression	Testing performed.
Performance in static torsion	Testing performed.
Performance in dynamic torsion	Testing performed.
Performance in static subsidence	Testing performed.
Performance in static expulsion	Testing performed.
Performance in static shear testing	Testing performed.
Wear debris characteristics	Testing performed.

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

The document refers to "non-clinical testing" and does not specify a "test set" in the context of human or patient data. The testing involved mechanical evaluations of the device itself. Therefore, concepts like sample size, country of origin, or retrospective/prospective data are not applicable in this context.

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

This information is not applicable as there was no human "test set" or diagnostic ground truth established by experts. The evaluation was based on engineering and mechanical performance testing.

4. Adjudication method for the test set:

Not applicable, as there was no human "test set" requiring adjudication.

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. The device is a physical vertebral body replacement system, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is not an algorithmic or AI-based device. The "performance" refers to the mechanical integrity and function of the implant itself.

7. The type of ground truth used:

The "ground truth" in this context is the established performance characteristics and safety profiles of the predicate devices. The study aimed to demonstrate that the StaXx® XDL System's mechanical performance was comparable to these known and approved devices.

8. The sample size for the training set:

Not applicable. There was no "training set" as this is not an AI/machine learning model. The mechanical tests were performed on the device prototypes.

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

Not applicable. There was no "training set." The engineering standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices served as the benchmarks for evaluating the substantial equivalence.

Summary

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K102315

Image /page/0/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A curved line is drawn below the words, suggesting a wave-like motion.

510(k) Summary StaXx® XDL System

AUG 1 9 2011

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise Drive
	Suite 210
	Shelton, CT 06484
Telephone:	203-712-1847
Telefax:	203-944-9493
Contact:	Denise Duchene
Date Prepared:	January 17, 2011

2. Device Information

Trade Name: Common Name: Classification Name: Classification/Code:

StaXx® XDL System Vertebral Body Replacement Spinal Intervertebral Body Fixation Orthosis Class II per 21 CFR 888.3060; MQP

3. Purpose of Submission

The purpose of this submission is to introduce to market a new vertebral body replacement device, the StaXx® XDL System.

4. Predicate Device Information

The StaXx® XDL System described in this submission is substantially equivalent to the following devices:

Predicate Device	Manufacturer	510(k) No.
StaXx® XD System	Spine Wave, Inc.	K052670
StaXx® XD System	Spine Wave, Inc.	K090315
StaXx® XD System	Spine Wave, Inc.	K101288
Nuvasive CoRoent® System	NuVasive, Inc.	K052210
Exactech Octane Device	Exactech, Inc.	K070218
Concorde Bullet Device	DePuy Spine, Inc.	K052746

5. Device Description

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6. Intended Use

7. Comparison of Technological Characteristics

The substantial equivalence of the subject StaXx® XDL System is shown by similarity in intended use, indications for use, materials and performance to the cited predicate devices. The StaXx® XDL System and the predicate devices are manufactured from PEEK-OPTIMA with 6% Barium Sulfate and contain wafers that are stacked into an expandable implant. These devices are all used as vertebral body replacement devices in the thoracolumbar spine.

8. Performance Data

Non-clinical testing was performed to demonstrate that the subject StaXx® XDL System is substantially equivalent to the listed predicate devices. The testing, performed to ASTM F2077 and ASTM F2267, included:

. Static axial compression,
Dynamic axial compression. .
Static torsion.
Dynamic torsion, .
. Static subsidence.
Static expulsion. .
Static shear testing, and .
Wear debris. .

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to predicates, the subject StaXx® XDL System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present anv new issues of safety or effectiveness.

Page 2 of 2

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spine Wave, Inc. % Ms. Denise Duchene Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

AUG 1 9 2011

Re: K102315

Trade/Device Name: StaXx® XDL System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 12, 2011 Received: August 15, 2011

Dear Ms. Duchene:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Denise Duchene

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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):	K102315
Device Name:	StaXx® XDL System

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

KID2315 510(k) Number_

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0000012

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.